Early Symptom Improvement Research Articles

Does Early Improvement in Anxiety Symptoms in Patients with Major Depressive Disorder Affect Remission Rates? A Post-Hoc Analysis of Pooled Duloxetine Clinic Trials

Objectives: Patients with major depressive disorder (MDD) and a comorbid anxiety disorder or significant anxiety symptoms have decreased functioning, increased risk of suicidality, and worse post-treatment outcomes. This pooled analysis of 8 duloxetine MDD trials was designed to determine whether early improvement in anxiety symptoms predicts MDD remission. Methods: Eight trials were pooled. Patients with a baseline 17-item Hamilton Rating Scale for Depression (HA-MD17) anxiety/somatization factor score ≥7 were considered to have anxious depression. Early response on the HAMD17 total score was defined as a 20% reduction at weeks 2 or 4, a 30% reduction at weeks 2 or 4, or a 50% reduction at weeks 2 or 4 in the HAMD17 anxiety subscale. Each category was analyzed separately for all patients. MDD remission is a score of ≤7 on the HAMD17 total score at study endpoint. Results: The early responder group in each analysis showed greater numerical improvement at endpoint on the HAMD17 total score than the nonresponder group. Duloxetine showed statistically significantly greater improvement than placebo in most nonresponder and responder subgroups. There were no statistically significant interaction effects for the difference between duloxetine and placebo for any of the anxious categories. Conclusion: Although patients who responded in the various response categories had greater numerical improvement and greater remission rates than nonresponding patients, the response and nonresponse groups did not differ statistically regarding the treatment effect of duloxetine. Therefore, early improvement in anxiety symptoms was not a predictor of greater endpoint remission of depressive symptoms for duloxetine treatment.

EPA-0204 – Early improvement of depressive symptoms and reduction of prefrontal cordance as predictors of response to venlafaxine ER in patients with resistant depression

Previous studies demonstrated the role of early improvement of depressive symptoms and change of QEEG prefrontal cordance in the outcome prediction of antidepressant treatment in depressive patients. The aim of study was to compare change of prefrontal QEEG theta cordance at week 1 and reduction of depressive symptoms at week 2 in the prediction of response to venlafaxine ER in patients with resistant depression. All patients (n=43) were hospitalized at Prague Psychiatric Center and were treated with venlafaxine for 4 weeks or more. Depressive symptoms were assessed using MADRS at baseline, week 2 and at the end of study. EEG data were monitored at baseline and after week 1. Cordance was computed at 3 frontal electrodes in theta frequency band. There were no significant differences between change of cordance at week 1 and reduction of depressive symptoms at week 2 in predictive ability in terms of AUC of ROC analysis (0.78±0.07 vs 0.74±0.08; p=0.75). Using ≥20% reduction of MADRS and reduction of cordance value as indicators of response we did not detect significant difference in their predictive parameters. The model combining both measures yielded value of AUC ROC analysis 0.86 (nonsignificantly better than individual predictors). Positive and negative predictive values of proposed models were 0.93 and 0.75. Both parameters were identified as predictors with comparable ability to differentiate between responders and non-responders. This study was supported by a grant from Internal Grant Agency of Ministry of Health of Czech Republic No. NT 14287 and grant RVO-PCP/2013

The New Nitinol Conformable Self-Expandable Metal Stents for Malignant Colonic Obstruction: A Pilot Experience as Bridge to Surgery Treatment

Introduction. Self-expandable metal stents (SEMS) are a nonsurgical option for treatment of malignant colorectal obstruction also as a bridge to surgery approach. The new nitinol conformable stent has improved clinical outcomes in these kinds of patients. We report a pilot experience with nitinol conformable SEMS placement as bridge to surgery treatment in patients with colorectal obstruction. Materials and Methods. Between April and August 2012, we collected data on colonic nitinol conformable SEMS placement in a cohort of consecutive symptomatic patients, with malignant colorectal obstruction, who were treated as a bridge to surgery. Technical success, clinical success, and adverse events were recorded. Results. Ten patients (7 male (70%)), with a mean age of 69.2 ± 10.1, were evaluated. The mean length of the stenosis was 3.6 ± 0.6 cm. Five patients (50%) were treated on an emergency basis. The median time from stent placement to surgery was 16 days (interquartile range 7–21). Technical and clinical success was achieved in all patients with a significant early improvement of symptoms. No adverse events due to the SEMS placement were observed. Conclusion. This pilot study confirmed the important role of nitinol conformable SEMS as a bridge to surgery option in the treatment of symptomatic malignant colorectal obstruction.

Early Symptom Improvement and Discontinuation of 5-α-Reductase Inhibitor (5ARI) Therapy in Patients With Benign Prostatic Hyperplasia (BPH)

Pharmacological treatment options for benign prostatic hyperplasia (BPH) commonly include α-blocker (AB) and 5-α-reductase inhibitor (5ARI) agents, which have separate but important attributes that carry clinical implications in terms of improvement of lower-urinary tract symptoms (LUTS) and clinical disease progression. This study hypothesized that administering AB therapy concomitantly with newly started 5ARI treatment would reduce the likelihood of 5ARI discontinuation through early symptom improvement. This retrospective analysis of the PharMetrics Integrated Medical and Pharmaceutical Database included men aged ≥50 years with ≥1 medical claim of BPH diagnosis and ≥1 prescription claim of a 5ARI with or without an AB. Patients initiating 5ARI monotherapy were propensity score matched with patients initiating combination AB + 5ARI therapy (1:1), with 5ARI time to discontinuation (30-day gap in treatment) compared between groups utilizing survival analysis techniques. The percentage of patients adherent to 5ARI therapy based on medication possession ratio (MPR) was assessed. After 180 days of follow-up, 61.7% of the combination therapy arm versus 59.2% of the monotherapy arm remained on therapy. Combination therapy patients were 10% less likely to discontinue 5ARI treatment (hazard ratio = 0.904; P = .006) and were more likely to be adherent when adherence was defined as MPR ≥70% and ≥75%. Based on an assessment of claims data, initiating AB with 5ARI therapy is associated with a lower rate of 5ARI discontinuation compared with 5ARI monotherapy. Early symptom relief from AB therapy may contribute to a lower discontinuation rate for concomitant 5ARI therapy.

Early clinical response as a predictor of subsequent response to ixekizumab treatment: results from a phase II study of patients with moderate-to-severe plaque psoriasis

Early identification of responsiveness to biologic treatments in psoriasis has significant clinical and economic implications. To evaluate whether early clinical improvements in Psoriasis Area and Severity Index (PASI) scores could predict subsequent clinical responses in patients treated with ixekizumab, an anti-interleukin-17 monoclonal antibody. This post hoc analysis was derived from a phase II study in patients with moderate-to-severe plaque psoriasis (n = 114) who received multiple doses of ixekizumab 10, 25, 75 or 150 mg subcutaneously over 20 weeks. PASI score improvements from baseline to weeks 2, 4 and 6 were evaluated to determine the optimal threshold for predicting subsequent PASI responses at week 12. Early clinical improvement in disease symptoms at weeks 4 and 6 was predictive of ≥ 75% improvement in PASI score (PASI 75) at week 12 with ≥ 90% predictability. A 40-50% improvement in PASI (PASI 40 to PASI 50) from baseline to weeks 4 and 6 was the optimum range for predicting PASI 75 response at week 12. For all doses combined, achieving PASI 40 at week 4 or week 6 was associated with high negative predictive values (NPVs) (80% and 95%, respectively) and positive predictive values (PPVs) (89% and 84%, respectively). For all doses combined, achieving PASI 50 at week 4 or week 6 was associated with NPVs of 71% and 89% and PPVs of 94% and 89%, respectively. Sensitivity analysis with the high-dose group (75 and 150 mg) results confirmed these findings. Early clinical responses (and nonresponse) may help predict later clinical responses in patients treated with ixekizumab.

Use of Mental Health Telemetry to Enhance Identification and Predictive Value of Early Changes During Augmentation Treatment of Major Depression

Standard clinical trial methodology in depression does not allow for careful examination of early changes in symptom intensity. The purpose of this study was to use daily "Mental Health Telemetry" (MHT) to prospectively record change in depressive and anxiety symptoms for depressed patients receiving augmentation treatment, and determine the extent and predictive capacity of early changes. We report results of a 6-week, open-label study of the addition of quetiapine XR (range, 50-300 mg) for adult patients (n = 26) with major depressive disorder who were nonresponsive to antidepressant treatment. In addition to regular study visits, all participants completed daily, wirelessly transmitted self-report ratings of symptoms on a Smartphone. Daily and 3-day moving average mean scores were calculated, and associations between early symptom change and eventual response to treatment were determined. Improvement in depressive and anxiety symptoms was identified as early as day 1 of treatment. Of the total decline in depression severity over 6 weeks, 9% was present at day 1, 28% at day 2, 39% at days 3 and 4, 65% at day 7, and 80% at day 10. Self-report rating of early improvement (≥20%) in depressive symptoms at day 7 significantly predicted responder status at week 6 (P = 0.03). Clinician-rated depressive and anxiety symptoms only became significantly associated with responder status at day 14. In conclusion, very early changes in depressive symptoms were identified using MHT, early changes accounted for most of total change, and MHT-recorded improvement as early as day 7 significantly predicted response to treatment at study end point.

The longitudinal interplay between negative and positive symptom trajectories in patients under antipsychotic treatment: a post hoc analysis of data from a randomized, 1-year pragmatic trial

BackgroundSchizophrenia is a highly heterogeneous disorder with positive and negative symptoms being characteristic manifestations of the disease. While these two symptom domains are usually construed as distinct and orthogonal, little is known about the longitudinal pattern of negative symptoms and their linkage with the positive symptoms. This study assessed the temporal interplay between these two symptom domains and evaluated whether the improvements in these symptoms were inversely correlated or independent with each other.MethodsThis post hoc analysis used data from a multicenter, randomized, open-label, 1-year pragmatic trial of patients with schizophrenia spectrum disorder who were treated with first- and second-generation antipsychotics in the usual clinical settings. Data from all treatment groups were pooled resulting in 399 patients with complete data on both the negative and positive subscale scores from the Positive and Negative Syndrome Scale (PANSS). Individual-based growth mixture modeling combined with interplay matrix was used to identify the latent trajectory patterns in terms of both the negative and positive symptoms. Pearson correlation coefficients were calculated to examine the relationship between the changes of these two symptom domains within each combined trajectory pattern.ResultsWe identified four distinct negative symptom trajectories and three positive symptom trajectories. The trajectory matrix formed 11 combined trajectory patterns, which evidenced that negative and positive symptom trajectories moved generally in parallel. Correlation coefficients for changes in negative and positive symptom subscale scores were positive and statistically significant (P < 0.05). Overall, the combined trajectories indicated three major distinct patterns: 1) dramatic and sustained early improvement in both negative and positive symptoms (n = 70, 18%), 2) mild and sustained improvement in negative and positive symptoms (n = 237, 59%), and 3) no improvement in either negative or positive symptoms (n = 82, 21%).ConclusionsThis study of symptom trajectories over 1 year shows that changes in negative and positive symptoms were neither inversely nor independently related with each other. The positive association between these two symptom domains supports the notion that different symptom domains in schizophrenia may depend on each other through a unified upstream pathological disease process.

Psychotherapy credibility ratings: Patient predictors of credibility and the relation of credibility to therapy outcome

Objective: The current investigation examined the relation between credibility ratings for adult psychotherapies and a variety of patient factors as well as the relation between credibility ratings and subsequent symptom change. Method: A pooled study database that included studies evaluating the efficacy of cognitive and psychodynamic therapies for a variety of disorders was used. For all studies, a three-item credibility scale was administered at session 2. Patient variables at baseline were used to predict early treatment credibility. Results: Early symptom improvement, age, education, and expectation of improvement were all significantly predictive of credibility scores at session 2. In one combined multiple regression model controlling for treatment, study, and early symptom change, age, education, and expectation of improvement remained significantly predictive of credibility scores. Credibility was predictive of subsequent symptom change even when controlling for age, education, expectation of improvement, and early symptom improvement. Conclusions: These findings suggest that age and education, in addition to expectations of improvement and the amount of early symptom improvement, may influence the patient's perceptions of the credibility of a treatment rationale early in the treatment process and that credibility ratings predict subsequent symptom change.

Early and sustained improvement with vilazodone in adult patients with major depressive disorder: post hoc analyses of two phase III trials

Objective:To retrospectively examine the timing of depressive symptom improvement in patients treated with vilazodone, a selective serotonin reuptake inhibitor (SSRI) and 5-HT1A partial agonist.Research design and methods:Post hoc analyses were conducted on pooled data from two phase III, multicenter, 8 week, double-blind, randomized, controlled trials (RCTs) of vilazodone 40 mg/day or placebo in adult patients with major depressive disorder (MDD).Clinical trial registration:ClinicalTrials.gov identifier: NCT00285376.ClinicalTrials.gov identifier: NCT00683592.Main outcome measures:Montgomery–Åsberg Depression Rating Scale (MADRS) total score least squares (LS) mean change from baseline to Week 8; MADRS single items LS mean change from baseline; MADRS responder analyses: response = ≥50% reduction in baseline score; cumulative response = proportion of patients at each assessment who achieved response that was sustained at all subsequent weeks; sustained response = ≥50% reduction in baseline MADRS total score at last two visits; and sustained response plus MADRS score ≤12 at the last two visits of the study.Results:LS mean difference (LSMD) and 95% confidence interval (95% CI) for change from baseline to Week 8 was significantly greater in favor of vilazodone versus placebo (−2.8 [−4.1 to −1.4]; p < 0.0001); differences between vilazodone and placebo were statistically significant beginning at Week 1. Early improvement in depressive symptoms was suggested by statistically significant separation from placebo on seven of ten MADRS single items as early as Week 1 or Week 2. A significantly greater proportion of vilazodone patients achieved response using all responder criteria, with early and sustained improvement consistently observed.Conclusions:Early and sustained improvement of depressive symptoms was retrospectively observed in patients treated with vilazodone; early findings may be related to overall treatment outcomes.

Efficacy and Safety of the Coadministration of Tadalafil Once Daily with Finasteride for 6 Months in Men with Lower Urinary Tract Symptoms and Prostatic Enlargement Secondary to Benign Prostatic Hyperplasia

Medical treatment for men with lower urinary tract symptoms and prostatic enlargement secondary to benign prostatic hyperplasia is 5α-reductase inhibitor monotherapy or coadministration with an α-blocker. We assessed the effects of tadalafil 5 mg coadministered with finasteride 5 mg during 26 weeks on lower urinary tract symptoms and sexual symptoms. In an international, randomized, double-blind, parallel study of men 45 years old or older who were 5α-reductase inhibitor naïve and had an I-PSS (International Prostate Symptom Score) of 13 or greater and prostate volume 30 ml or greater, 350 were treated with placebo/finasteride and 345 received tadalafil/finasteride for 26 weeks. Changes in lower urinary tract symptoms secondary to benign prostatic hyperplasia were assessed with the I-PSS, erectile dysfunction improvements were assessed with the IIEF-EF (International Index of Erectile Function-Erectile Function) in sexually active men and safety was assessed by evaluating adverse events. Least squares mean changes from baseline in I-PSS after 4, 12 and 26 weeks of tadalafil/finasteride coadministration were -4.0, -5.2 and -5.5, respectively. Corresponding values for placebo/finasteride coadministration were -2.3, -3.8 and -4.5 (p ≤ 0.022 at all visits favoring tadalafil/finasteride coadministration). I-PSS subscores (storage and voiding) and quality of life index were also numerically improved with tadalafil/finasteride coadministration. Least squares mean changes from baseline in IIEF-EF with tadalafil/finasteride coadministration were 3.7 after 4 weeks, and 4.7 after 12 and 26 weeks. Corresponding values for placebo/finasteride coadministration were -1.1, 0.6 and -0.0 (p <0.001 at all visits favoring tadalafil/finasteride coadministration). Tadalafil/finasteride coadministration was well tolerated and most adverse events were mild/moderate. The coadministration of tadalafil/finasteride provides early improvement in lower urinary tract symptoms in men with benign prostatic hyperplasia and prostatic enlargement. Tadalafil/finasteride coadministration also improves erectile function in men who have comorbid erectile dysfunction.

An early improvement in depressive symptoms predicts symptomatic remission of schizophrenia treated with quetiapine

The aim of this study was to determine whether an early improvement in depressive symptoms is a predictor of symptomatic remission in schizophrenia. Patients with DSM-IV schizophrenia diagnosis who received antipsychotic treatment but did not fulfill Andreasen's symptomatic remission criteria were recruited. Each patient received quetiapine with a flexible dose strategy of 300-800 mg daily for 4 weeks after a 1-week washout period of previous antipsychotics. Remission was defined by Andreasen's criteria, which includes eight items of the Positive and Negative Symptom Scale with scores of less than three in each item. Seventy-five patients completed the study. Of these, 27 (36%) achieved symptomatic remission after treatment with quetiapine. A significant improvement in depressive symptoms was found in both the remission and the nonremission groups, although the improvement was less pronounced in the nonremission group at the endpoint. Binary logistic regression analysis showed that age (β=-0.07, P=0.02) and early improvement in depressive symptoms within the first 3 days were predictive of symptomatic remission (β=-0.27, P=0.01) for the treatment of schizophrenia. Our data suggest that an early improvement in depressive symptoms in the treatment of schizophrenia is crucial for symptomatic remission.

The relationship between disease activity and depressivesymptoms severity and optimism—results from the IMPROVED study

To assess depressive symptoms severity and dispositional optimism in patients with recent onset arthritis both before and after 4 months treatment. Two hundred twenty-two patients with recent onset RA and undifferentiated arthritis in the IMPROVED study filled out the Beck Depression Inventory (BDI-II) to assess depressive symptoms severity and the Life Orientation Test Revised (LOT-R) to measure optimism before and after 4 months of treatment. All patients were treated with methotrexate 25 mg/week and prednisone 60 mg/day (tapered to 7.5 mg/day in 7 weeks). Linear regression analysis was used to assess the association between the disease activity score (DAS) and its components (tender joint count, general well-being measured with a visual analogue scale (VAS), swollen joint count, and erythrocyte sedimentation rate) with the BDI-II an LOT-R scores. In general, depressive symptoms were mild. The DAS was an independent predictor of depressive symptoms scores both at baseline and after 4 months follow-up, in particular tender joint count and VAS global health. Disease activity was not associated with the level of optimism. Nevertheless, patients who achieved clinical remission improved significantly more in both depression score and optimism score than patients who did not. Patients with early arthritis report improvement in depressive symptoms and optimism with improvement in disease activity and achieving clinical remission. Depression scores are associated with pain and unwell being but not with swollen joint counts and inflammatory parameters.

Pretreatment anterior cingulate activity predicts antidepressant treatment response in major depressive episodes

Major depressive disorder leads to substantial individual and socioeconomic costs. Despite the ongoing efforts to improve the treatment for this condition, a trial-and-error approach until an individually effective treatment is established still dominates clinical practice. Searching for clinically useful treatment response predictors is one of the most promising strategies to change this quandary therapeutic situation. This study evaluated the predictive value of a biological and a clinical predictor, as well as a combination of both. Pretreatment EEGs of 31 patients with a major depressive episode were analyzed with neuroelectric brain imaging technique to assess cerebral oscillations related to treatment response. Early improvement of symptoms served as a clinical predictor. Treatment response was assessed after 4 weeks of antidepressant treatment. Responders showed more slow-frequency power in the right anterior cingulate cortex compared to non-responders. Slow-frequency power in this region was found to predict response with good sensitivity (82 %) and specificity (100 %), while early improvement showed lower accuracy (73 % sensitivity and 65 % specificity). Combining both parameters did not further improve predictive accuracy. Pretreatment activity within the anterior cingulate cortex is related to antidepressive treatment response. Our results support the search for biological treatment response predictors using electric brain activity. This technique is advantageous due to its low individual and socioeconomic burden. The benefits of combining both, a clinically and a biologically based predictor, should be further evaluated using larger sample sizes.

Effects of the Temporary Placement of a Self-Expandable Metallic Stent in Benign Pyloric Stenosis

Background/AimsThe use of self-expandable metallic stents (SEMS) is an established palliative treatment for malignant stenosis in the gastrointestinal tract; therefore, its application to benign stenosis is expected to be beneficial because of the more gradual and sustained dilatation in the stenotic portion. We aimed in this prospective observational study to evaluate the efficacy and safety of temporary SEMS placement in benign pyloric stenosis.MethodsTwenty-two patients with benign stenosis of the prepylorus, pylorus, and duodenal bulb were enrolled and underwent SEMS placement. We assessed symptom improvement, defined as an increase of at least 1 degree in the gastric-outlet-obstruction scoring system after stent insertion.ResultsNo major complications were observed during the procedures. After stent placement, early symptom improvement was achieved in 18 of 22 patients (81.8%). During the follow-up period (mean 10.2 months), the stents remained in place successfully for 6 to 8 weeks in seven patients (31.8%). Among the 15 patients (62.5%) with stent migration, seven (46.6%) showed continued symptomatic improvement without recurrence of obstructive symptoms.ConclusionsDespite the symptomatic improvement, temporary SEMS placement is premature as an effective therapeutic tool for benign pyloric stenosis unless a novel stent is developed to prevent migration.

Early improvement as a predictor of acute treatment outcome in manic or mixed episodes in bipolar-1 disorder: A pooled, post hoc analysis from the asenapine development program

ObjectiveTo assess whether early symptom improvement predicts later treatment outcome in acute manic/mixed episodes of bipolar I disorder using Young Mania Rating Scale (YMRS) or Clinical Global Impression scale, bipolar disorders (CGI–BP) assessments. MethodsData were pooled from two 3-week randomized controlled studies with asenapine (ASE; n=372), olanzapine (OLA; n=391), or placebo (PL; n=197). Early improvement was defined as reduction of YMRS total scores (≥15%, ≥20%, ≥25%) or CGI–BP severity scores (≥1 point change) at days 2, 4, and 7. Treatment outcome at week 3 was defined as response (YMRS: ≥50% score reduction; CGI–BP severity: “minimally ill” or better) or remission (YMRS total score ≤12; CGI–BP severity: “not at all ill”). Odds ratios (ORs) and predictive performance statistics were calculated. ResultsEarly improvement occurred in a substantial percentage of patients and was associated with significantly increased ORs for response or remission. For ASE, results were significant as early as day 2 on all measures of YMRS and CGI-severity of mania assessment. For all treatments sensitivity and negative predictive values increased from days 2 to 7 for all YMRS and CGI–BP measures, while specificity values decreased. ConclusionIn acute manic/mixed episodes, early improvement within 1 week of treatment was associated with significantly increased ORs of endpoint response or remission. While only a subset of early improvers reach the endpoint treatment goals, absence of improvement within week 1 of treatment initiation strongly predicts the unlikely success of subsequent treatment. Further, CGI-based predictors had predictive properties similar to those based on the YMRS scale.

The daily response for proton pump inhibitor treatment in Japanese reflux esophagitis and non-erosive reflux disease

We investigated comparison according to reflux esophagitis and non-erosive reflux disease about “daily” symptom improvement for proton pump inhibitor treatment. We enrolled 57 reflux esophagitis and 90 non-erosive reflux disease patients. They took rabeprazole 10 mg/day for 28 days and completed “daily” in the Frequency Scale for the Symptoms of GERD from baseline until day 14, and after 28 days of treatment. The efficacy endpoint was the improvement rates in Frequency Scale for the Symptoms of GERD, based on baseline. Frequency Scale for the Symptoms of GERD was decreased in reflux esophagitis and non-erosive reflux disease (p<0.001) and was significantly lower in reflux esophagitis than in non-erosive reflux disease from the first day of treatment (p<0.05). Symptomatic improvement rates were also significantly higher in reflux esophagitis (50.3 ± 44.9%) than in non-erosive reflux disease (31.7 ± 43.2%) from the first day of treatment (p<0.0001). The symptomatic improvement rates in reflux esophagitis were significant increased from the second day of treatment until after 28 days of treatment (p = 0.0006), however, these in non-erosive reflux disease were significant increased from third days until after 28 days of treatment (p = 0.0002). In non-erosive reflux disease, the improvement of dysmotility symptom was particularly gradual as well as of reflux symptom, too. As for results of prediction of proton pump inhibitor response (completed symptom resolution) form early symptom improvement within 1 week, it was able to predict proton pump inhibitor response from the symptom improvement rate on 3 days in reflux esophagitis and on day 7 in non-erosive reflux disease. In conclusion, the prediction of the proton pump inhibitor response in non-erosive reflux disease was slow in comparison with reflux esophagitis. The cause was gradual improvement of dysmotility symptom.

Early improvement of psychotic symptoms with lithium monotherapy as a predictor of later response in mania

Although lithium has been the first line agent in the treatment of bipolar disorder (BD), few studies have evaluated lithium's efficacy in mania with psychosis and its association with later response. Furthermore, given the widespread concern about antipsychotic side effects, answering a question about whether lithium alone can manage to treat both psychotic and non-psychotic mania seems a very relevant one. The present study addresses the antipsychotic efficacy of lithium monotherapy in acute mania and early improvement of psychotic symptoms as a predictor of later response of manic symptoms. Forty-six patients presenting a manic episode (32 with psychotic features and 14 subjects without psychotic features) were treated for 4 weeks with lithium monotherapy and evaluated weekly using the Young Mania Rating Scale (YMRS). Subjects with rapid cycling, substance abuse/dependence, or mixed episodes were excluded. The overall antimanic efficacy of lithium in psychosis vs. non-psychosis groups was evaluated. In addition, early improvement of psychotic symptoms and its prediction of subsequent response (>50% decrease in total YMRS scores) or remission were evaluated. Lithium showed a similar efficacy in both psychosis and non-psychosis mania. Early improvement of psychotic symptoms was associated with clinical response and remission at endpoint.

Therapeutic alliance in two treatments for adolescent anorexia nervosa

The aim of this study was to examine the relationship between therapeutic alliance and treatment outcome (remission status) in family-based treatment (FBT) and adolescent-focused therapy (AFT) for adolescents with anorexia nervosa (AN). Independent observers rated audiotapes of early therapy sessions using the Working Alliance Inventory-Observer Version (WAI-o). Outcome was defined using established cut-points for full and partial remission. To control for effects of early symptom improvement, changes in weight- and eating-related psychopathology prior to the alliance session were calculated and entered as a covariate in each analysis. Participants in AFT had significantly higher alliance scores; however, overall scores were high in both therapies. The alliance was not a predictor of full remission for either treatment, though it was a non-specific predictor for partial remission. Therapeutic alliance is achievable in adolescents with AN in both AFT and FBT, but demonstrated no relationship to full remission of the disorder.

A community-based study of enduring eating features in young women.

We conducted a prospective exploration of the temporal course of eating disorder (ED) symptoms in two cohorts of community women. One hundred and twenty-two young women (Cohort 1) identified in a general population based survey with ED symptoms of clinical severity agreed to participate in a 5-year follow-up study. A comparative sample (Cohort 2) of 706 similar aged self-selected college women (221 with disordered eating) was recruited one year later. Both ED groups were given a health literacy package in the first year. ED symptoms, health related quality of life, and psychological distress were assessed annually with the Eating Disorder Examination Questionnaire, the Short Form—12 Health Survey and the Kessler Psychological Distress Scale, respectively. Forty percent (Cohort 1) and 30.3% (Cohort 2) completed questionnaires at each year of follow-up. In both groups, there was early improvement in ED symptoms which plateaued after the first year, and participants retained high EDE-Q scores at 5 years. BMI increased as expected. Mental health related quality of life scores did not change but there were small improvements in psychological distress scores. The findings suggest little likelihood of spontaneous remission of ED problems in community women.

Effects of Immunotherapy on the Distribution and Clonality of TCR Vγ and Vδ Subfamily T Cells in Allergic Rhinitis Patients

Effects of Immunotherapy on the Distribution and Clonality of TCR Vγ and Vδ Subfamily T Cells in Allergic Rhinitis PatientsThe aim of this study was to investigate the changes in the peripheral specific IgE level, distribution of TCR Vg and Vd subfamily T cells and mRNA expressions of TCR Vg I-III following specific immunotherapy (SIT) with house-dust-mite extract in allergic rhinitis (AR) patients. Ten AR patients undergoing SIT with house-dust-mite extract for 1 year were recruited. Quantitative analysis of immunofluorescence was performed to detect the serum specific IgE (sIgE) level before and after SIT; RT-PCR-genescan analysis was employed to detect the mRNA expressions of TCR Vg (I-III) and Vd (1-8) in the peripheral mononuclear cells followed by analysis of T cell clonality. Real-time quantitative PCR was applied to detect the expressions of TCR Vg I-III genes. Ten healthy volunteers served as controls. For AR patients, SIT treatment could improve the symptoms, but the serum sIgE level was not markedly decreased. Before SIT, the expressions of TCR Vg I-III gene were similar between AR patients and controls (P&gt;0.05) but markedly decreased after SIT in AR patients (P&lt;0.05 in TCR VgI and VgII). The expressions of TCR Vd (1-8) before and after SIT were 5.3±0.82 and 4.9±0.57, respectively, and that in healthy controls was 5.2±1.40. Vd1, 2, 3 and 6 were the most common genes found in these patients. Significant difference in the TCR Vd6 subfamily T cells was found between the two groups. Polyclonal or biclonal proliferation was found in the T cells of patients before SIT and in healthy controls, but oligoclonal proliferation in only 1 subject before SIT. After SIT, the proportion of patients with oligoclonal proliferation of T cells (6/10) was markedly increased (P&lt;0.05). SIT for 1 year could alter the expressions of TCR Vg I-III genes, the distribution of TCR Vg and Vd T cells and the ways in which T cells proliferate. The early improvement of symptoms following immunotherapy might not be related to the serum sIgE content in AR patients, but associated with the TCR gd T cells, especially the TCR V d6 T cells.