Clinical Global Impression Severity Subscale Research Articles

Reliability and validity of the Estonian version of the Clinical Institute of Withdrawal Assessment for Alcohol scale

Aims Our aim was to adapt the Clinical Institute of Withdrawal Assessment for Alcohol scale (CIWA-Ar) into Estonian and test its reliability and validity. Methods A total of 72 patients with alcohol withdrawal syndrome participated in the study. In order to assess the interrater reliability, at first assessment the CIWA-Ar was simultaneously completed by two nurses. In order to assess the sensitivity of the CIWA-Ar to the changes in the severity of the withdrawal syndrome, as well as its correlations to several indices characterizing the subjects’ current condition, the CIWA-Ar, the Clinical Global Impression Severity subscale (CGI-S), the visual analogue scales for the assessment of the general feeling of malaise, anxiety and depression were filled in and the vital signs were measured at inclusion, in 4 h and after the withdrawal syndrome had been resolved. Results The intraclass correlation coefficient (ICC) for the Estonian version of the CIWA-Ar total score, used as an indicator of interrater reliability, was excellent. The CIWA-Ar had significant correlations with the psychiatrists’ CGI-S ratings of the severity of the patient’s condition at all assessment points. Significant correlations were also found between CIWA-Ar and patients’ self-ratings, the highest correlations found with self-rated anxiety and general feeling of malaise. CIWA-Ar total score did not correlate with simultaneously measured heart rate, systolic and diastolic blood pressure at the first assessment. At the second assessment, heart rate had a significant correlation with the CIWA-Ar total score. Conclusion Our study provides confirmation that the CIWA-Ar tool is well applicable in the Estonian language and culture setting.

Efficacy and safety of duloxetine in painful diabetic peripheral neuropathy: a systematic review and meta-analysis of randomized controlled trials

BackgroundPainful diabetic peripheral neuropathy (PDPN) is a key concern in clinical practice. In this systematic review and meta-analysis, we compared duloxetine and placebo treatments in terms of their efficacy and safety in patients with PDPN.MethodsFollowing the PRISMA guidelines, we searched the Cochrane Library, PubMed, and Embase databases for relevant English articles published before January 11, 2021. Treatment efficacy and safety were assessed in terms of pain improvement, patient-reported health-related performance, and patients’ quality of life.ResultsWe reviewed a total of 7 randomized controlled trials. Regarding pain improvement, duloxetine was more efficacious than placebo (mean difference [MD] − 0.89; 95% confidence interval [CI] − 1.09 to − 0.69; P < .00001). Furthermore, duloxetine significantly improved the patients’ quality of life, which was assessed using the Clinical Global Impression severity subscale (MD − 0.48; 95% CI − 0.61 to − 0.36; P < .00001), Patient Global Impression of Improvement scale (MD − 0.50; 95% CI − 0.64 to − 0.37; P < .00001), and European Quality of Life Instrument 5D version (MD 0.04; 95% CI 0.02 to 0.07; P = .0002). Severe adverse events were rare, whereas nausea, somnolence, dizziness, fatigue, constipation, and decreased appetite were common; approximately, 12.6% of all patients dropped out because of the common symptoms.ConclusionsDuloxetine is more efficacious than placebo treatments in patients with PDPN. The rarity of severe adverse events indicates that duloxetine is safe. When a 60-mg dose is insufficient, 120 mg of duloxetine may improve PDPN symptoms. Our findings may help devise optimal treatment strategies for PDPN.Systematic review registrationPROSPERO CRD42021225451

Prospective, Open Trial of Adjunctive Triple Chronotherapy for the Acute Treatment of Depression in Adolescent Inpatients.

The aim of this pilot study was to explore the feasibility and proof of concept of triple chronotherapy (TCT) as a nonpharmacological adjunctive treatment in the acute management of depression in the adolescent population. Thirty-one adolescents with nonpsychotic moderate-to-severe depression were included in the study. The 4-day TCT intervention comprised one night of sleep deprivation followed by 3 days of sleep phase advancement and daily bright light therapy. Primary outcomes were feasibility and depression, as measured by the Hamilton Depression Scale-17 (HAMD-17). Secondary outcomes included severity of illness, anxiety, self-harm, insomnia, and suicidality. Twenty-nine (94%) adolescents completed the 4-day TCT intervention. Twenty-six (84%) of the 31 enrolled patients experienced a reduction in depressive symptoms of at least 50% from baseline; 24 (77%) achieved remission, defined as a HAMD-17 score less than 8. The mean depression score was severe before the start of the intervention ( \documentclass{aastex}\usepackage{amsbsy}\usepackage{amsfonts}\usepackage{amssymb}\usepackage{bm}\usepackage{mathrsfs}\usepackage{pifont}\usepackage{stmaryrd}\usepackage{textcomp}\usepackage{portland, xspace}\usepackage{amsmath, amsxtra}\usepackage{upgreek}\pagestyle{empty}\DeclareMathSizes{10}{9}{7}{6}\begin{document} $$\overline X$$ \end{document} = 21.8 ± 3.8) and dropped below the remission threshold by day 4 ( \documentclass{aastex}\usepackage{amsbsy}\usepackage{amsfonts}\usepackage{amssymb}\usepackage{bm}\usepackage{mathrsfs}\usepackage{pifont}\usepackage{stmaryrd}\usepackage{textcomp}\usepackage{portland, xspace}\usepackage{amsmath, amsxtra}\usepackage{upgreek}\pagestyle{empty}\DeclareMathSizes{10}{9}{7}{6}\begin{document} $$\overline X$$ \end{document} = 4.4 ± 5.1; p < 0.001); the mean depression score was mild at 1 week (n = 17; \documentclass{aastex}\usepackage{amsbsy}\usepackage{amsfonts}\usepackage{amssymb}\usepackage{bm}\usepackage{mathrsfs}\usepackage{pifont}\usepackage{stmaryrd}\usepackage{textcomp}\usepackage{portland, xspace}\usepackage{amsmath, amsxtra}\usepackage{upgreek}\pagestyle{empty}\DeclareMathSizes{10}{9}{7}{6}\begin{document} $$\overline X$$ \end{document} = 9.3 ± 5.2; p < 0.001) and 1 month (n = 10, \documentclass{aastex}\usepackage{amsbsy}\usepackage{amsfonts}\usepackage{amssymb}\usepackage{bm}\usepackage{mathrsfs}\usepackage{pifont}\usepackage{stmaryrd}\usepackage{textcomp}\usepackage{portland, xspace}\usepackage{amsmath, amsxtra}\usepackage{upgreek}\pagestyle{empty}\DeclareMathSizes{10}{9}{7}{6}\begin{document} $$\overline X$$ \end{document} = 7.8 ± 5.2; p < 0.001). Severity of illness scores according to the Clinical Global Impressions severity subscale improved from a mean of 5.3 at baseline to 3.1 following the TCT intervention (p < 0.0001); the effect was sustained through the 1-week postdischarge and the 1-month follow-up. Secondary outcomes showed significant improvement following the 4-day TCT intervention; improvement was sustained through the 1-week and 1-month follow-up periods. This pilot study determined TCT to be a feasible, safe, rapid, and potentially effective adjunctive treatment for depression in the adolescent population.

Characteristics, diagnoses, illness course and risk profiles of inpatients admitted for at least 21 days to an Australian private psychiatric hospital.

To perform a clinical and risk audit of private hospital inpatients staying in hospital at least 21 days. Of 492 admissions for ≥21 days in 2016, 40 were randomly selected for audit. Characteristics, illness severity and course using the Clinical Global Impression severity (CGI-S) subscale and improvement (CGI-I) subscale, and clinical risk profiles were ascertained at admission, day 15 and discharge by two psychiatrists. The cases were 65% female, age 50.0±16.2 years (range 24-86), 43% in relationships, and 28% on disability support. The length of stay was 29±7 days. On admission 88% were severely or markedly ill on the CGI-S subscale. Thirty-nine of 40 cases had ≥3 psychiatric diagnoses: 93% depression, 48% bipolar, 15% schizophrenia. High risk was present in suicide risk (48%), illness-induced dysfunction risk (78%) and physical risk (28%). By day 15, 63% were not improved or marginally worse. Suicide ratings were unimproved. By the time of discharge, illness severity and risk ratings were significantly reduced. Private hospital inpatients staying ≥21 days were predominantly female and had severe, diagnostically complex illnesses and high risk ratings. Most were still seriously unwell after 15 days. Patients improved significantly by the time of discharge (though were by no means recovered), indicating that the duration of hospitalisation was appropriate.

Effects of tandospirone augmentation in major depressive disorder patients with high anxiety: A multicenter, randomized, parallel-controlled, open-label study

BackgroundHigh levels of anxiety symptoms are common in individuals with major depressive disorder (MDD). Adjunctive anxiolytics are widely used in such patients; however, only a few studies have examined the strategy using tandospirone. This study aimed to evaluate the efficacy and safety of adjunctive tandospirone in individuals with MDD and high level of anxiety symptoms. MethodsA multicenter, randomized, parallel-controlled, open-label study was conducted to evaluate the efficacy and safety of tandospirone coupled with selective serotonin reuptake inhibitors (SSRIs) in patients with MDD and high level of anxiety symptoms. Two hundred and forty-five patients fulfilling the DSM-IV-TR criteria for MDD were randomly assigned to 6 weeks of either SSRIs and tandospirone or SSRIs alone treatment. The efficacy was measured by HAMA total scores, HAMD-17 total scores, and Clinical Global Impressions severity subscale (CGI-S) score. ResultsAfter a 6-week follow-up, two hundred and thirty patients completed this study. Tandospirone coupled with SSRIs significantly improved depressive and anxiety symptoms compared to monotherapy with SSRIs as assessed by HAMD-17 total score (P = 0.003), HAMA total score (P = 0.010), and CGI-S score at week 6 (P = 0.003). The incidence rate of treatment-emergent adverse events (TEAEs) was similar in both groups; the therapy was well-tolerated. ConclusionsShort-term tandospirone augmentation was effective and well-tolerated in this study. Addition of tandospirone may improve outcomes in MDD patients with high anxiety.

An 8-Week Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Cariprazine in Patients With Bipolar I Depression.

The authors evaluated the efficacy, safety, and tolerability of cariprazine, an atypical antipsychotic candidate, in adult patients with acute bipolar I depression. This was an 8-week multinational, multicenter, randomized, double-blind, placebo-controlled, parallel-group, fixed-dose study in adult patients with bipolar I disorder experiencing a current major depressive episode. Patients were randomly assigned (1:1:1:1) to receive placebo or cariprazine at 0.75, 1.5, or 3.0 mg/day. The primary and secondary efficacy parameters were change from baseline to week 6 on the Montgomery-Åsberg Depression Rating Scale (MADRS) and the Clinical Global Impressions severity subscale (CGI-S), respectively, analyzed using a mixed-effects model for repeated measures on the modified intent-to-treat population. The intent-to-treat population comprised 571 patients (141 in the placebo group and 140, 145, and 145 in the cariprazine 0.75-, 1.5-, and 3.0-mg/day groups). Cariprazine at 1.5 mg/day showed significantly greater improvement on MADRS total score change from baseline to week 6 compared with placebo; the least squares mean difference was -4.0 (95% CI=-6.3, -1.6; significant after adjustment for multiple comparisons). Cariprazine at 3.0 mg/day showed greater MADRS score reduction than placebo (-2.5, 95% CI=-4.9, -0.1; not significant when adjusted for multiple comparisons). The 0.75 mg/day dosage was similar to placebo. A similar pattern for significance was observed on the CGI-S (1.5 mg/day: least squares mean difference=-0.4, 95% CI=-0.6, -0.1; 3.0 mg/day: -0.3, 95% CI=-0.5, -0.0). The most common adverse events (≥10%) in cariprazine-treated patients were akathisia and insomnia; weight gain was slightly higher with cariprazine than with placebo. Cariprazine at 1.5 mg/day demonstrated consistent efficacy compared with placebo across outcomes and was generally well tolerated, suggesting efficacy for the treatment of bipolar I depression.

Effects of switching from olanzapine to aripiprazole on the metabolic profiles of patients with schizophrenia and metabolic syndrome: a double-blind, randomized, open-label study.

BackgroundPatients with schizophrenia suffer high rates of metabolic derangements on some antipsychotic medications that predispose them to cardiovascular diseases. Keeping this fact in mind, we planned this open-label study to see the effect on various metabolic parameters after switching stable schizophrenia subjects, who had developed metabolic syndrome on olanzapine, to aripiprazole.MethodsSixty-two patients with schizophrenia who were stable on olanzapine and were fulfilling modified National Cholesterol Education Program (NCEP) Adult Treatment Panel III (ATP-III) criteria for the presence of metabolic syndrome were enrolled on the study. Patients were randomly assigned either to switch to aripiprazole or to stay on olanzapine, on a 1:1 basis. Cross-tapering over a period of 1 month was done while switching patients to aripiprazole. Laboratory assessment for metabolic parameters was done at baseline, 8 weeks, and 24 weeks after enrollment; efficacy assessment was done using the Positive and Negative Syndrome Scale (PANSS) at baseline and 24 weeks, the Clinical Global Impressions severity subscale (CGI-S) at baseline, and the Clinical Global Impressions improvement subscale (CGI-I) at 24 weeks.ResultsAll parameters of metabolic syndrome (waist circumference, blood pressure, triglyceride level, fasting blood glucose, and high-density lipoprotein cholesterol) kept deteriorating in the stay group, compared with a continuous improvement in the switch group over time. At the end of the study, 26 patients (100%) from the stay group and 15 patients (42.8%) from switch group met the modified NCEP ATP-III criteria for presence of metabolic syndrome (P<0.001). There were no statistically significant differences between groups in psychopathology changes as measured by the PANSS total score and CGI-I scores.ConclusionClinically stable patients with schizophrenia who are taking olanzapine and who have evidence of metabolic syndrome can be successfully switched to aripiprazole, with improvement in various parameters of metabolic syndrome and without any significant change in efficacy measures.

Effect of OROS Methylphenidate on Encopresis in Children with Attention-Deficit/Hyperactivity Disorder

Although encopresis shows a high rate of comorbidity in patients with attention-deficit/hyperactivity disorder (ADHD), the etiologic origin of this relationship and the effect of ADHD drugs on encopresis are unclear. In this chart review, we explored the effect of OROS long-acting methylphenidate (MPH) treatment on encopresis in children with ADHD. We also evaluated the relationship between the clinical variables of ADHD and encopresis. The sample consisted of 21 children and adolescents (20 boys and 1 girl) with encopresis and coexisting ADHD 7-15 years of age. Their clinical characteristics and baseline (visit 1) and end of the second months' (visit 2) Conners' Parent Rating Scale (CPRS) subscores were recorded. Retrospective clinician determinations were made using the Clinical Global Impressions-Severity subscale (CGI-S) for encopresis severity and the Clinical Global Impressions-Improvement subscale (CGI-I) for encopresis response. According to the CGI-I, 14 subjects (71.4 %) showed much or very much improvement in their encopresis at the second visit. All of the CPRS scores showed a significant reduction during the second visit. No association was found between the CGI-I score and the changes in any of the CPRS scores. Baseline oppositional defiant disorder (ODD) and conduct disorder (CD) scores were correlated with the CGI-S score; however, no association was found between core ADHD symptom severity and the CGI-S score. With regard to the encopresis outcome, the baseline CD score was negatively correlated with the CGI-I score, and the baseline ODD score was prone to show a negative correlation with the CGI-I score. These results suggest that coexisting behavioral problems may be a vulnerability factor based on the severity of encopresis, and that MPH treatment may have a positive effect on encopresis in children and adolescents with ADHD.

Modulation of motor cortex excitability in obsessive-compulsive disorder: An exploratory study on the relations of neurophysiology measures with clinical outcome

Low-frequency repetitive transcranial magnetic stimulation (rTMS) to supplementary motor area (SMA) showed clinical benefit in obsessive-compulsive disorder (OCD). Here we tested whether clinical improvement was associated with enhanced cortical inhibition as measured by single and paired-pulse TMS variables. In 18 OCD patients receiving 4 weeks of either active or sham rTMS in a double-blind randomized trial, we assessed bilateral resting and active motor thresholds (RMT and AMT), cortical silent period (CSP), short-interval intracortical inhibition (SICI) and intracortical facilitation (ICF). We tested correlations between changes in Yale-Brown Obsessive Compulsive Scale-Self-report (Y-BOCS-SR), Clinical Global Impression-Severity subscale (CGI-S) and cortical excitability measures. Active rTMS increased right hemisphere RMT whose change correlated with Y-BOCS-SR improvement. Baseline RMT hemispheric asymmetry, defined as the difference between left and right hemispheres RMT, and its normalization after active rTMS correlated with Y-BOCS-SR and CGI-S improvements. Active rTMS also increased right hemisphere SICI whose change correlated with Y-BOCS-SR and CGI-S at week 4, and with normalization of baseline RMT hemispheric asymmetry. Treatment-induced changes in cortical excitability measures are consistent with an inhibitory action of SMA rTMS on dysfunctional motor circuits in OCD. Correlations of neurophysiology measures with therapeutic outcome are supportive of the role of SMA in the modulation of OCD symptoms.

Risperidone, quetiapine, and olanzapine adjunctive treatments in major depression with psychotic features: a comparative study

ObjectivesThe purpose of this study was to compare the effectiveness of novel antipsychotics in the treatment of psychotic depression.MethodConsecutive patients who were admitted (n = 51) with a confirmed diagnosis of major depression with psychotic features (delusions or hallucinations or both) participated in this open-label, naturalistic study. All patients were treated with selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) (citalopram or venlafaxine extended release [XR]), and atypical antipsychotic agents were added, as tolerated, during the first week of initiating the citalopram or venlafaxine. There were patients (n = 16) who received risperidone, who received quetiapine (n = 20), and who received olanzapine (n = 15), as an adjunctive treatment to either citalopram or venlafaxine for at least 8 weeks. Outcome measures included the Clinical Global Impression-Severity subscale (CGI-S), as the primary outcome measure, as well as the Hamilton Rating Scale for Depression-21 item (HAM-D21) and the Brief Psychiatric Rating Scale (BPRS). Tolerance to treatments and weight changes were monitored over the period of the trial.ResultsAll patients completed the trial with no drop outs. At 8 weeks, there was a statistically significant (P < 0.001) clinical improvement in all outcome measures for both the depressive and psychotic symptoms, for all three groups of atypical adjunctive treatments. Utilizing analysis of variance (ANOVA), there were no significant differences between the three adjunctive treatment groups in outcome measures. The three antipsychotic agents were equally tolerated. At 8 weeks there was slight increase in weight in the three treatment groups, which was statistically significant (P > .01) in the olanzapine group.ConclusionQuetiapine, risperidone, and olanzapine, given as adjunctive treatment with SSRIS or SNRIs can significantly and equally improve depressive and psychotic symptoms, in the short-term treatment of major depression with psychotic features. The author recommends that large controlled trials be conducted to examine the differences in long-term efficacy and tolerance between the atypical antipsychotic agents, in the treatment of major depression with or without psychotic features.

Adjunctive atomoxetine to SSRIs or SNRIs in the treatment of adult ADHD patients with comorbid partially responsive generalized anxiety (GA): an open-label study

To examine changes in partially responsive anxiety symptoms utilizing adjunctive treatment with atomoxetine in the treatment of adult ADHD patients with comorbid partially responsive anxiety symptoms. Consenting adult patients (n=29) with confirmed diagnosis of generalized anxiety and comorbid attention deficit hyperactivity disorder (ADHD) participated in this open-label study. All patients had significant comorbid anxiety symptoms (HAM-A>7) and failed to respond to 8-week trials of selective serotonin reuptake inhibitors (SSRIs) or noradrenaline reuptake inhibitors (SNRIs). All patients were treated with atomoxetine as adjunctive to SSRIs or to SNRIs and were followed for at least 12 weeks. The primary outcome measure was the Clinical Global Impression severity subscale. Other scales included the Hamilton Anxiety Scale (HAM-A), the adult ADHD Self-Report Scale (ASRS-v1.1) symptom checklist, and Sheehan's Disability Scale. Baseline measures prior to the treatment with atomoxetine were compared to those at 4, 8, and at 12 weeks of treatment. Monitoring for pulse, blood pressure, and weight changes was carried out at baseline and at end point. Twenty-seven patients (93%) completed this open-label study. There was significant resolution of symptoms of all outcome measures, including the symptoms of anxiety, as shown by changes from baseline in HAM-A, ASRS-v1.1, and CGI at 12 weeks (P<.001). Also, there was significant reduction in the disability score at 12 weeks. Patients completed the study, tolerated the adjunctive treatment, and there were no significant cardiovascular or weight changes. Two patients withdrew from the study during the first 4 weeks of treatment due to side effects. Atomoxetine can be used as an adjunctive treatment in adult patients with ADHD and comorbid partially responsive anxiety symptoms.

The mixed amphetamine salt extended release (Adderall XR, Max-XR) as an adjunctive to SSRIS or SNRIS in the treatment of adult ADHD patients with comorbid partially responsive generalized anxiety: an open-label study

To examine the changes in partially responsive anxiety symptoms utilizing adjunctive treatment with the mixed amphetamine salt extended release (Adderall XR, MAX-XR) in the treatment of adult ADHD patients, with comorbid refractory anxiety. Consenting adult patients (n = 32) with confirmed diagnosis of generalized anxiety (GA) and comorbid (ADHD) participated in this open-label study. All patients had significant comorbid anxiety symptoms (HAM-A > 7) and failed to respond to 8-week trials of Serotonin Reuptake Inhibitors (SSRIs) or Norepinephrine Reuptake inhibitors (SNRIs). All patients were treated with the "Mixed Amphetamine salts Extended Release Adderall XR, (MAS-XR), as adjunctive to SSRIs or to SNRIs and were followed for at least 12 weeks. The primary effectiveness measure was the Clinical Global Impression severity subscale (CGI-S). Other scales included the Hamilton Anxiety Scale (HAM-A), the adult ADHD Self-Report Scale (ASRS-v1.1) symptom checklist, and Sheehan's disability scale. Baseline measures prior to the treatment with MAS-XR were compared to those at 4, 8, and at 12 weeks of treatment. Monitoring for pulse, blood pressure, and weight changes was carried out at baseline and at end point. All patients completed this open-label trial. There was significant and robust resolution of symptoms of all effectiveness measures, including the symptoms of anxiety, as shown by changes from baseline in HAM-A, ASRS-v1.1, and CGI at 8 weeks. Also there was significant reduction in the disability score at 12 weeks. Patients tolerated the treatment, and there were no significant cardiovascular changes at 12 weeks. There was decrease in mean weight at 12 weeks by 2.2 kg (P < .001). Mixed amphetamine salts MAS-XR can be used in adult patients with ADHD and comorbid anxiety symptoms. Larger controlled studies are needed to support the effectiveness of mixed amphetamine salts in patients with comorbid anxiety symptoms. Treatments need to include the targeting of the ADHD symptoms effectively in order to achieve better resolution of anxiety symptoms.

Novel rating scales for schizophrenia — Targeted Inventory on Problems in Schizophrenia (TIP-Sz) and Functional Assessment for Comprehensive Treatment of Schizophrenia (FACT-Sz)

Objective Many rating scales have been in use to evaluate various symptomatic domains, and eventually there are too many scales to be selected and widely utilized in busy real-world settings. Relevant, quick, and user-friendly assessment scales are needed to facilitate measurement-based treatment of schizophrenia. Methods The authors created unique convenient assessment scales: Targeted Inventory on Problems in Schizophrenia (TIP-Sz), and Functional Assessment for Comprehensive Treatment of Schizophrenia (FACT-Sz). The TIP-Sz consists of 10 items (behavioral dyscontrol/disorganization, hostility/agitation/violence, indifference/affective withdrawal/motor retardation, symptoms on mood/anxiety/obsession/compulsion, insight/reality testing, social competence/independence, adherence to treatment, therapeutic alliance/comfort of therapists on the situation, overall prognostic impression, and subjective well-being/satisfaction with therapy). They are all common and frequently problematic, and each item is rated from 0–10. The FACT-Sz evaluates psychosocial functioning of patients with a score of 0–100, and is judged entirely on an objective basis. Their correlations with the frequently utilized Positive and Negative Syndrome Scale (PANSS), Global Assessment of Functioning (GAF), and Clinical Global Impression-Severity subscale were determined. Results Data on 36 patients, assessed separately by four experienced psychiatrists, were analyzed. Under an excellent interrater reliability among raters (Intraclass correlation coefficients: 0.822–0.966), correlations among the scales were very high (Spearman's ρ: 0.825–0.909), and other indicators of the scale were generally good. Specifically, the TIP-Sz and FACT-Sz could be rated at 1/3–1/4 of time to complete the PANSS and GAF. Conclusion The TIP-Sz and FACT-Sz proved to be reliable and valid, which would be of value in daily clinical practice as a minimum standardized assessment set.

Lamotrigine adjunctive treatment in resistant unipolar depression: an open, descriptive study

Adjunctive treatment of lamotrigine compared to other antidepressants in the treatment of partially responsive, poorly functioning patients with unipolar depression was assessed. Fourteen consenting patients with confirmed DSM-IV-R diagnosis of unipolar depression were identified as treatment resistant. All patients failed at least two 8-week treatment trials with antidepressants. All were treated with lamotrigine as an adjunct to other antidepressants for at least 6 months. The primary effectiveness measure was the Clinical Global Impression Severity subscale (CGI-S). Other scales included the Montgomery-Asberg Depression Scale (MADRS) and the Global Assessment of Functioning Scale (GAF). Monitoring for skin rashes, headache, dizziness, somnolence, and gastrointestinal disturbances was carried out to assess for adverse events. Baseline measures prior to adding lamotrigine were compared to those at 8 weeks and 6 months with adjunctive treatment. Twelve patients of the total (n=14) completed the trial, and two discontinued treatment. There was significant, rapid, and robust resolution in symptoms in all effectiveness measures, including the core symptoms of depression, as shown by the changes from baseline in CGI-S, and MADRS at 8 weeks. Social and occupational functioning was significantly improved at 6 months. Eight patients returned to gainful employment or started schooling. Patients tolerated the adjunctive lamotrigine treatment well. Lamotrigine may have antidepressant properties in patients with unipolar depression and may have an earlier onset of action when given in combination with antidepressants.