One-year Treatment Research Articles

Memantine in Behavioral Variant Frontotemporal Dementia: Negative Results

We tested the efficacy and tolerability of one-year treatment with memantine (10 mg bid) in behavioral variant frontotemporal dementia (bvFTD). BvFTD patients aged 45 to 75 years, with a Mini-Mental Status Examination (MMSE) score ≥19, were enrolled in a national, randomized, double-blind, placebo-controlled (DBPC), Phase II trial. The primary endpoint was the CIBIC-Plus (Clinician's Interview-Based Impression of Change Plus Caregiver Input). The secondary endpoints included: Neuropsychiatric Inventory (NPI), Frontal Behavioral Inventory (FBI), Mattis Dementia Rating Scale (MDRS), MMSE, Disability Assessment for Dementia (DAD), and the Zarit Burden Inventory (ZBI). Forty-nine patients were analyzed. At baseline, mean age was 65.6 years and mean MMSE was 25.0 (range: 19-30). On the CIBIC-Plus, 52 weeks after baseline, there were no significant differences between the memantine group (n = 23) and the placebo group (n = 26); p = 0.4458; however, 10 patients had worsened in the memantine group versus 17 in the placebo group. For the secondary endpoints there were no differences in the evolution of score between the memantine group and the placebo group (MMSE, p = 0.63); (MDRS, p = 0.95); (NPI, p = 0.25); (ZBI, p = 0.43); (DAD, p = 0.10) except for the FBI score, which was lower in the memantine group (p = 0.0417). Memantine was well-tolerated. This is the first DBPC trial in a large group of bvFTD patients involving neuroprotective treatment. A multinational study with a larger number of patients is now needed in order to verify the results of our study. The trial is registered with ClinicalTrials.gov; number NCT 00200538.

Association of intrahepatic cccDNA reduction with the improvement of liver histology in chronic hepatitis B patients receiving oral antiviral agents

Covalently closed circular DNA (cccDNA) of hepatitis B virus (HBV) is difficult to eradicate using current antiviral therapy. This study compares cccDNA reduction with relation to liver histology in nucleoside/nucleotide-naïve chronic hepatitis B patients receiving oral antiviral monotherapy (n=35), including entecavir (ETV, n=13), adefovir dipivoxil (ADV, n=22) or placebo (n=14). Serum HBV DNA, intrahepatic total HBV DNA and cccDNA are quantified. Histological hepatic examination is performed at baseline and at 48 weeks of treatment. Treatment with ETV or ADV shows significant median reduction in serum HBV DNA (-6.21 and -4.27 log(10) copies/mL) and intrahepatic total HBV DNA (-1.69 and -1.23 log(10) copies/cell). Intrahepatic cccDNA levels are reduced slightly in the ETV and the ADV groups, but do not differ statistically from the placebo group (-0.17 vs. -0.01 vs. 0.02 copies/cell). Only the level of intrahepatic cccDNA correlates with Knodell necroinflammation activity (r=0.527, P<0.001) and Ishak fibrosis severity (r=0.348, P=0.015) before treatment. Multivariate logistic regression analysis indicates that treatment-induced cccDNA reduction is associated with improved necroinflammation (P=0.041) and fibrosis (P=0.026). In conclusion, baseline intrahepatic cccDNA loads correlate with histologic activity. Although one-year ETV or ADV treatment is insufficient for cccDNA eradication, oral antiviral therapies may improve liver histology, probably by suppressing intrahepatic cccDNA.

Early psychosocial intervention for youth at risk for bipolar I or II disorder: a one-year treatment development trial

Previous studies have identified behavioral phenotypes that predispose genetically vulnerable youth to a later onset of bipolar I or II disorder, but few studies have examined whether early psychosocial intervention can reduce risk of syndromal conversion. In a one-year open trial, we tested a version of family-focused treatment adapted for youth at high risk for bipolar disorder (FFT-HR). A referred sample of 13 children (mean 13.4±2.69 years; 4 boys, 9 girls) who had a parent with bipolar I or II disorder participated at one of two outpatient specialty clinics. Youth met DSM-IV criteria for major depressive disorder (n=8), cyclothymic disorder (n=1), or bipolar disorder not otherwise specified (n=4), with active mood symptoms in the past month. Participants were offered FFT-HR (12 sessions in four months) with their parents, plus psychotropic medications as needed. Independent evaluators assessed depressive symptoms, hypomanic symptoms, and global functioning at baseline and then every four months for one year, with retrospective severity and impairment ratings made for each week of the follow-up interval. Families were mostly adherent to the treatment protocol (85% retention), and therapists administered the FFT-HR manual with high levels of fidelity. Youth showed significant improvements in depression, hypomania, and psychosocial functioning scores on the Adolescent Longitudinal Interval Follow-up Evaluation. They also showed significant improvements in Young Mania Rating Scale and Children's Depression Rating Scale scores. FFT-HR is a promising intervention for youth at high risk for BD. Larger-scale randomized trials that follow youth into young adulthood will be necessary to determine whether early psychosocial intervention can reduce the probability of developing bipolar I or II disorder among genetically vulnerable youth.

Abrupt Cessation of One-Year Clopidogrel Treatment Is Not Associated With Thrombotic Events

We aimed to examine the rate of thrombotic events after discontinuation of one year clopidogrel therapy in patients with implanted coronary stent, and to determine platelet aggregability by multiple electrode analyzer after cessation of clopidogrel. This prospective, multicenter study enrolled 200 patients subjected to coronary stent implantation and treated with aspirin + clopidogrel one year after the stent placement. Platelet aggregation was measured using 3 agonists [adenosine diphosphate with PGE(1) (ADPHS), arachidonic-acid (ASPI), and thrombin receptor activating peptide (TRAP)] on the day of cessation of clopidogrel and at 10, 45, and 90 days after clopidogrel was stopped. Two thrombotic events were registered during the 6-months follow up (one ischemic stroke and one myocardial infarction; incidence of 1%). The mean values of ADP + PGE(1)- and ASPI-induced aggregation 10 - 90 days after the cessation of clopidogrel were significantly higher than values obtained before the termination of the drug (P < 0.001, all). Cessation of clopidogrel did not influence the TRAP-induced aggregation, which reached the plateau in all measurements. In conclusion, the incidence of thrombotic events after the cessation of one-year clopidogrel treatment might be lower than expected in patients with implanted coronary stent.

One-year Treatment of Morpholino Antisense Oligomer Improves Skeletal and Cardiac Muscle Functions in Dystrophic mdx Mice

One-year Treatment of Morpholino Antisense Oligomer Improves Skeletal and Cardiac Muscle Functions in Dystrophic mdx Mice

Influence of one-year treatment with lovastatin on myocardial remodeling and ischemia in patients with coronary artery disease

Emerging evidence assumes that statins have a benefit to influence the myocardial remodeling and ischemia in patients with coronary artery disease (CAD). Our aim was to investigate the possible and direct favorable effects of lovastatin on left ventricular (LV) systolic, diastolic function and myocardial ischemia in patients with CAD. This randomized prospective study consisted of 83 patients (46 males; mean age 54.3 ± 6.5 years) with CAD and dyslipidemia. All patients were randomized to following groups: the 1st group (n=44) received lovastatin (20-60 mg/day), hypolipidemic diet and physical training; the 2nd group (n=39) - hypolipidemic diet and physical training. Lipid spectrum, Doppler-echocardiography, bicycle exercise test and 24-hour ambulatory electrocardiographic monitoring were done at baseline and were repeated after 12 months of treatment. The data were analyzed by using the paired and unpaired Student's t-tests. In the 1st group there was an improvement of lipid spectrum (p=0.05) without significant changes of liver transaminases and other side effects. After treatment LV ejection fraction increased from 59.8 ± 8.04 to 62.9 ± 4.43% in lovastatin alone group (p=0.01). Unlike 2nd group, the 1st group's patients had also reduction of myocardial ischemia: increased exercise time (5.21 ± 1.81 vs. 5.96 ± 1.76 min; p=0.05), METS (4.42 ± 0.6 vs. 4.78 ± 0.7; p=0.05), magnitude (1.12 ± 0.34 vs. 0.81 ± 0.19 mm; p=0.05) and duration (2.16 ± 0.67 vs. 1.04 ± 0.46 min, p=0.01) of ST segment depression , as well as number of leads with ST segment depression (2.18 ± 0.72 vs. 1.31 ± 0.67; p=0.05). Lipid-lowering therapy with lovastatin improved the LV systolic function and decreased myocardial ischemia.

One-year Treatment of Morpholino Antisense Oligomer Improves Skeletal and Cardiac Muscle Functions in Dystrophic mdx Mice

Antisense therapy has been successful to skip targeted dystrophin exon with correction of frameshift and nonsense mutations of Duchenne muscular dystrophy (DMD). Systemic production of truncated but functional dystrophin proteins has been achieved in animal models. Furthermore, phase I/II clinical trials in United Kingdom and the Netherlands have demonstrated dystrophin induction by local and systemic administrations of antisense oligomers. However, long-term efficacy and potential toxicity remain to be determined. The present study examined 1-year systemic effect of phosphorodiamidate morpholino oligomers (PMO) treatment targeting mutated dystrophin exon 23 in mdx mice. PMO induced dystrophin expression dose-dependently and significantly improved skeletal muscle pathology and function with reduced creatine kinase (CK) levels by a regimen of 60 mg/kg biweekly administration. This regimen induced <2% dystrophin expression in the heart, but improved cardiac functions demonstrated by hemodynamics analysis. The results suggest that low levels of dystrophin induction may be able to provide detectable benefit to cardiac muscle with limited myopathy. Body weight, serum enzyme tests, and histology analysis showed no sign of toxicity in the mice treated with up to 1.5 g/kg PMO for 6 months. These results indicate that PMO could be used safely as effective drugs for long-term systemic treatment of DMD.

Long-Term Safety of Mometasone Furoate/Formoterol Combination for Treatment of Patients with Persistent Asthma

Objective: The combination of inhaled corticosteroid (ICS) and long-acting β2-agonist is recommended for treatment of patients with persistent asthma inadequately controlled on ICS monotherapy. This study was conducted to evaluate the long-term safety of mometasone furoate/formoterol (MF/F) administered through metered-dose inhaler (MDI) in patients with persistent asthma previously on medium- to high-dose ICS. Methods: This was a 52-week, randomized, multicenter, parallel-group, open-label, evaluator-blinded study. At baseline, 404 patients (aged ≥12 years) were stratified according to their previous ICS dose (medium or high), then randomized 2:1 to receive twice-daily treatment of MF/F (200/10 or 400/10 μg) or fluticasone propionate/salmeterol (FP/S; 250/50 or 500/50 μg). The primary endpoint was the number and percentage of patients reporting any adverse event (AE). Additional safety evaluations included plasma cortisol 24-hour area under the curve (AUC0−24 h) and ocular changes. Pulmonary function, asthma symptoms, and use of rescue medication were monitored. Results: The incidence of ≥1 treatment-emergent AE was similar across treatment groups (MF/F 200/10 μg, 77.3% [n= 109]; FP/S 250/50 μg, 82.4% [n= 56]; MF/F 400/10 μg, 79.2% [n= 103]; FP/S 500/50 μg, 76.9% [n= 50]). Rates of treatment-related AEs were also similar across treatment groups (MF/F 200/10 μg, 28.4%; FP/S 250/50 μg, 23.5%; MF/F 400/10 μg, 23.1%; FP/S 500/50 μg, 20.0%). Headache (3.7%) and dysphonia (2.7%) were the most common treatment-related AEs overall. The nature and frequency of AEs and the decreases in plasma cortisol AUC0−24 h observed with MF/F treatment were similar to those observed with FP/S treatment. Ocular events were rare (2–6% overall incidence among treatment groups); in particular, no posterior subcapsular cataracts were reported. Only three patients discontinued the study because of treatment-related ocular AEs (two for lens disorders in the MF/F 400/10 μg group; one for reduced visual acuity in the FP/S 250/50 μg group) and no asthma-related deaths occurred. Furthermore, MF/F showed numerical improvement in lung function and clinical benefits by reducing asthma symptoms and rescue medication use. Conclusions: One-year treatment with the new combination therapies – twice-daily MF/F-MDI 200/10 and 400/10 μg – is safe and well tolerated in patients with persistent asthma.

Comparison of the efficacy of lamivudine and telbivudine in the treatment of chronic hepatitis B: a systematic review

BackgroundChronic viral hepatitis B remains a global public health concern. Currently, several drugs, such as lamivudine and telbivudine, are recommended for treatment of patients with chronic hepatitis B. However, there are no conclusive results on the comparison of the efficacy of lamivudine (LAM) and telbivudine (LdT) in the treatment of chronic hepatitis B.ResultsTo evaluate the comparison of the efficacy of LAM and LdT in the treatment of chronic hepatitis B by a systematic review and meta-analysis of clinical trials, we searched PUBMED (from 1990 to April 2010), Web of Science (from 1990 to April 2010), EMBASE (from 1990 to April 2010), CNKI (National Knowledge Infrastructure) (from 1990 to April 2010), VIP database (from 1990 to April 2010), WANFANG database (from 1990 to April 2010), the Cochrane Central Register of Controlled Trials and the Cochrane Database of Systematic Review. At the end of one-year treatment, LdT was better than LAM at the biochemical response, virological response, HBeAg loss, therapeutic response, while less than at the viral breakthrough and viral resistance, but there was no significant difference in the HBeAg seroconversion and HBsAg response. LdT was better than LAM at the HBeAg seroconversion with prolonged treatment to two years.ConclusionsIn summary, LdT was superior in inhibiting HBV replication and preventing drug resistance as compared to LAM for CHB patients. But LdT may cause more nonspecific adverse events and can lead to more CK elevation than LAM. It is thus recommended that the LdT could be used as an option for patients but adverse events, for example CK elevation, must be monitored.

Long‐term efficacy and safety of eslicarbazepine acetate: Results of a 1‐year open‐label extension study in partial‐onset seizures in adults with epilepsy

To evaluate the long-term efficacy and safety of once daily eslicarbazepine acetate (ESL) as adjunctive therapy for partial-onset seizures in adults with epilepsy. One-year open-label treatment extension with ESL in patients who completed a placebo-controlled pivotal study (Epilepsia 2009; 50: 454-463). Starting dose was 800 mg once daily, for 4 weeks; thereafter, dose could be titrated up or down. Doses of concomitant antiepileptic drugs were to be kept stable. Overall, 314 patients were enrolled. The intent-to-treat population consisted of 312 patients, and 239 (76.6%) completed 1 year of treatment. ESL median dose was 800 mg once daily. Compared to baseline, median seizure frequency decreased by 39% during the first 4 weeks and between 48% and 56% thereafter. The responder rate (≥50% seizure reduction) was 41% during weeks 1-4 and, thereafter ranged between 48% and 53%. The proportion of seizure-free patients per 12-week interval ranged between 8.7% and 12.5%. Quality of life, as measured by the Quality of Life in Epilepsy Inventory-31 (QOLIE-31), and depressive symptoms, as measured by the Montgomery Asberg Depression Rating Scale (MADRS), improved significantly compared to baseline. Treatment-emergent adverse events (TEAEs) were reported by 51% of patients. The most frequent TEAEs were headache (10%), dizziness (10%), diplopia (5%), and nasopharyngitis (5%). TEAEs were mostly (97%) of mild to moderate intensity. Eleven patients (3.5%) discontinued due to TEAEs. There were no results of laboratory tests raising safety concerns. Sustained therapeutic effect, favorable tolerability and safety, and an improvement in quality of life and depressive symptoms were observed during long-term add-on treatment of partial-onset seizures in adults with once daily ESL.

Helping overweight women become more active: Need support and motivational regulations for different forms of physical activity

Objectives This study analyzed mechanisms by which a one-year obesity treatment intervention based on self-determination theory (SDT) influenced physical activity level and whether motivational predictors differed for structured vs. lifestyle forms of physical activity. Design Randomized controlled trial lasting 1-year. Method Pre-menopausal overweight and obese women ( n = 239; 37.6 ± 7.1 y; 31.5 ± 4.1 kg/m 2) participated in a group intervention designed to increase physical activity and motivation, following SDT. Partial least squares (PLS) latent variable modeling was used to test a cross-sectional multiple-level mediation model comprising experimentally-manipulated contextual need support, perceived need satisfaction, and motivational regulations for two distinct forms of physical activity. Results The structural model explained a large amount of variance (62%) for intrinsic motivation, and moderate amounts of variance (16–25%) for the remaining regulations and exercise behaviors. Moderate and vigorous exercise was positively influenced by intrinsic motivation ( p < .001) whereas lifestyle physical activity was not significantly predicted by motivational regulations. Behavioral regulations were influenced by perceived autonomy and perceived competence and both needs were affected by contextual support from treatment climate ( p < .001). Conclusions Results provide support for using the SDT framework to understand physical activity motivational processes in the context of weight management. Results also highlight structured and lifestyle physical activity as being promoted by different processes as a result of the intervention: more direct effects on lifestyle physical activity and indirect effects on structured exercise, mediated by intrinsic motivation.

Efficacy of integrative respiratory rehabilitation training in exercise ability and quality of life of patients with chronic obstructive pulmonary disease in stable phase: a randomized controlled trial

Chronic obstructive pulmonary disease (COPD) is an important clinical disease, and its global prevalence and mortality rates are high. It is meaningful to investigate the efficacy of integrative respiratory rehabilitation training in quality of life and respiratory physiology of COPD patients in stable phase. To observe the efficacy of integrative respiratory rehabilitation training in exercise ability and quality of life of COPD patients in stable phase. Eighty outpatients and inpatients with COPD from Department of Respiratory Medicine, Taihe Hospital, Yunyang Medical College were randomly divided into 4 groups, with 20 patients in each group. The patients in group A only received drug therapy, the patients in group B received traditional qigong training, the patients in group C received modern rehabilitation training, and the patients in group D received integrative respiratory rehabilitation training. Chronic respiratory questionnaire (CRQ), 6-minute walking distance and Borg score in each group were examined before and after one-, three-, and six-month and one-year treatment. The 6-minute walking distance, Borg score and CRQ score in group A had no significant changes after treatment (P>0.05). After one-month treatment, there were no significant differences in 6-minute walking distance and Borg score in groups B, C and D as compared with those before treatment (P<0.05). After three-month treatment, 6-minute walking distance and Borg score were improved in groups B, C and D (P<0.05). After six-month and one-year treatment, 6-minute walking distance, Borg score and CRQ score in groups B, C and D were improved as compared with those before treatment (P<0.05), and there were significant differences between group D and any of groups A, B and C (P<0.05). Modern rehabilitation training, traditional qigong training and integrative respiratory rehabilitation training programs all can improve the quality of life and exercise ability of COPD patients, and integrative respiratory rehabilitation training program is better than modern rehabilitation training and traditional qigong training programs. The efficacy of respiratory rehabilitation training is time-dependent, and need long-time adherence to the therapy.

One-year treatment with exenatide vs. Insulin Glargine: Effects on postprandial glycemia, lipid profiles, and oxidative stress

ObjectiveThe objective of the present study was to investigate the effects of one-year treatment with exenatide or Insulin Glargine, followed by a 5-week off-drug period, on postprandial lipidaemia, glycaemia and measures of oxidative stress. MethodsSixty-nine metformin-treated patients with type 2 diabetes were randomised (using apermuted block randomisation scheme stratified by site and baseline HbA1c stratum (≤8.5% or >8.5%) of which 60 completed (exenatide n=30; Insulin Glargine n=30) the pre-treatment and on-drug meal test. Postprandial glucose, lipids and lipoproteins, and oxidative stress markers were studied at week −1, 51, and after a 5-week off-drug period following a breakfast and lunch mixed-meal containing 50g fat, 75g carbohydrates, and 35g protein. Results51-Week exenatide treatment resulted in a significant reduction of prandial glucose, triglycerides, apo-B48, calculated VLDL-C, FFA and MDA excursions whereas Insulin Glargine predominantly reduced fasting glucose, FFA and MDA. Changes in markers of oxidative stress were related to changes in postprandial glucose and triglyceride excursions, independent of treatment arm. All postprandial measures returned to pre-treatment values in both groups after 5-week cessation of study treatment. ConclusionExenatide showed beneficial effects on postprandial glycaemia and lipidaemia, and these effects were related to changes in the oxidative stress markers MDA and oxLDL during one year of treatment as compared to Insulin Glargine. Following cessation of both exenatide and Insulin Glargine measures returned to pre-treatment values, suggesting that ongoing treatment is necessary to maintain the beneficial effects of either therapy.

T1064 One-Year Treatment Continuation With Alosetron is High Irrespective of IBS-D Severity

T1064 One-Year Treatment Continuation With Alosetron is High Irrespective of IBS-D Severity

Effects of Kuntai Capsule and hormone replacement therapy on cognitive function and mental symptoms of early postmenopausal women: a randomized controlled trial

Conjugated equine estrogen (CEE) treatment, a hormone replacement therapy, is restricted for use in perimenopausal and postmenopausal women because of security issues. Consequently, traditional Chinese herbal medicine has become an alternative choice for the patients with contraindications to hormone replacement therapy. To evaluate the efficacy and safety of Kuntai Capsule and CEE in treating cognitive function disorder and mental symptoms of early postmenopausal women. A total of 57 cases of early postmenopausal women from Outpatient Department of West China Women and Children's Hospital were included. The subjects were randomly divided into two groups: Kuntai group with 28 cases and CEE group with 29 cases. The patients in Kuntai group received 6 g Kuntai capsules three times a day. The patients in CEE group received CEE 0.3 mg and 0.6 mg alternately once a day (average dose of 0.45 mg/d). The patients with intact uterus in CEE group were treated with 2 mg medroxyprogesterone acetate daily. In one-year treatment course, the recognition function and mental symptoms of each patient were investigated by questionnaires of Mini-Mental State Examination (MMSE), Kupperman, and quality of life (QOL) every three months. Both intention-to-treat (ITT) and per-protocol set (PPS) analyses were done. The MMSE, Kupperman index and QOL scores at each time point were improved as compared with those before treatment (P<0.05), however there were no statistical differences between the two groups (P>0.05). The MMSE scores showed a tendency to escalate while mental symptoms investigated by Kupperman index and QOL scale showed a downtrend. No severe adverse effects occurred in the study phase and no statistical difference in incidence of side effects between the two groups was found except for vaginal bleeding. The incidence rates of vaginal bleeding in CEE and Kuntai groups were 39.3% and 11.1% respectively (P=0.029). Both Kuntai Capsule and CEE may contribute to maintain the cognitive function and ameliorate mental symptoms of early postmenopausal women.

One-year treatment costs of trauma care in the USA

Although injuries are a leading cause of morbidity and mortality in the USA, few prior studies exist on the costs of trauma care. This article estimates treatment costs of care for 12 months following injury. Primary and secondary data were collected on over 5000 moderate-to-severely injured patients 18–84 years of age discharged from 69 US hospitals. Acute and post-acute costs of care were estimated from a combination of data sources: UB92 hospital bills, patient surveys, medical record abstracts, and where available, Medicare claims. Key analysis variables were demographic characteristics, insurance status and nature and severity of injury. Mean 1-year cost per patient of trauma care in our population was $75,210. On average, 58% of cost was accounted for by the index hospitalization. Total 1-year treatment cost of adult major trauma in the USA was conservatively estimated to be US$27 billion annually (2005).

Patients With Dual Diagnoses or Substance Use Disorders Only: 12-Step Group Participation and 1-Year Outcomes

We compared outpatients (regional facility) with substance use and psychiatric (N == 199) or only substance use (N == 146) disorders on baseline and one-year symptoms (93%% follow-up), and treatment and 12-step group participation over the year (2005). We examined whether diagnostic status moderated associations between participation and outcomes (Addiction Severity Index) with regressions. At follow-up, dual diagnosis patients had more severe symptoms, despite comparable treatment. The groups were comparable on 12-step participation, which was associated with better outcomes. However, associations of participation with better outcomes were weaker for dual diagnosis patients. Study (VA HSR&D-funded) implications and limitations are noted and research suggested.

One-Year Treatment Outcomes of African-American and Hispanic Patients With Bipolar I or II Disorder in STEP-BD

Few studies have compared treatment outcomes of African-American, Hispanic, and non-Hispanic white patients with bipolar disorder. The U.S. Systematic Treatment Enhancement Program for Bipolar Disorder compared one-year outcomes for bipolar I or II disorder from each of these racial-ethnic groups. African Americans (N=155) were retrospectively compared with a matched group of non-Hispanic whites (N=729), and Hispanics (N=152) were compared with a separate matched group of non-Hispanic whites (N=822). Response and recovery outcomes were examined. Survival analysis was used to compare time to treatment response for depression (Montgomery-Asberg Depression Rating Scale) and mania (Young Mania Rating Scale) as well as global assessment of functioning (Global Assessment of Functioning). For manic and depressive symptoms, time to response and proportion of responders were similar across groups. Over the study year the proportion of days well was similar across groups. A smaller proportion of African Americans met criteria for improved global functioning. Depression response among African Americans with psychotic symptoms was slower than the response among African Americans without psychotic symptoms and among non-Hispanic whites with or without psychotic symptoms. No differences between Hispanics and non-Hispanic whites in response times and recovery were observed. Results are consistent with U.S. clinical trials for other psychiatric disorders, which have reported similar outcomes for ratings of primary symptoms. Baseline psychotic symptoms are likely a significant contributor when African Americans with bipolar disorder are slow to recover. These results may be less generalizable to uninsured patients.

One-Year Treatment Outcomes of African-American and Hispanic Patients With Bipolar I or II Disorder in STEP-BD

One-Year Treatment Outcomes of African-American and Hispanic Patients With Bipolar I or II Disorder in STEP-BD

Involvement in the US criminal justice system and cost implications for persons treated for schizophrenia

BackgroundIndividuals with schizophrenia may have a higher risk of encounters with the criminal justice system than the general population, but there are limited data on such encounters and their attendant costs. This study assessed the prevalence of encounters with the criminal justice system, encounter types, and the estimated cost attributable to these encounters in the one-year treatment of persons with schizophrenia.MethodsThis post-hoc analysis used data from a prospective one-year cost-effectiveness study of persons treated with antipsychotics for schizophrenia and related disorders in the United States. Criminal justice system involvement was assessed using the Schizophrenia Patients Outcome Research Team (PORT) client survey and the victimization subscale of the Lehman Quality of Life Interview (QOLI). Direct cost of criminal justice system involvement was estimated using previously reported costs per type of encounter. Patients with and without involvement were compared on baseline characteristics and direct annual health care and criminal justice system-related costs.ResultsOverall, 278 (46%) of 609 participants reported at least 1 criminal justice system encounter. They were more likely to be substance users and less adherent to antipsychotics compared to participants without involvement. The 2 most prevalent types of encounters were being a victim of a crime (67%) and being on parole or probation (26%). The mean annual per-patient cost of involvement was $1,429, translating to 6% of total annual direct health care costs for those with involvement (11% when excluding crime victims).ConclusionsCriminal justice system involvement appears to be prevalent and costly for persons treated for schizophrenia in the United States. Findings highlight the need to better understand the interface between the mental health and the criminal justice systems and the related costs, in personal, societal, and economic terms.