This study aimed to evaluate the efficacy and safety of quetiapine fumarate extended-release (XR) in the treatment of Chinese patients with acute schizophrenia. Multicenter, double-blind, double-dummy, active-controlled non-inferiority randomized study in Chinese patients (n = 388) with schizophrenia randomly assigned to quetiapine XR or chlorpromazine for 6 weeks. Primary outcome was the change from baseline in Positive and Negative Syndrome Scale (PANSS) total score at the end of treatment. Safety objectives included adverse event (AE) monitoring, laboratory test results, and electrocardiograms. Changes in PANSS total score were -33.4 for quetiapine XR and -35.9 for chlorpromazine (P > 0.05). Least squares mean changes were: positive subscale, -9.9 ± 0.53 and -11.1 ± 0.51; negative subscale, -5.9 ± 0.50 and -6.7 ± 0.48; general psychopathology subscale, -12.9 ± 0.74 and -13.9 ± 0.71; aggression and hostility cluster scores, -4.8 ± 0.33 and -5.4 ± 0.32; and depression cluster scores, -1.8 ± 0.18 and -1.7 ± 0.18, for quetiapine XR and chlorpromazine, respectively. For quetiapine XR, AEs were constipation, dizziness, insomnia, and agitation, and nine patients (4.6%) discontinued due to AEs. For chlorpromazine, AEs were extrapyramidal symptoms, constipation, insomnia, dizziness, and agitation, and 17 patients (8.9%) discontinued due to AEs; two patients reported serious AEs. Quetiapine XR monotherapy was not inferior to chlorpromazine for treating acute schizophrenia in Chinese patients and was well tolerated.
Objective: This study examined the use, demographic and clinical correlates of antipsychotic polypharmacy (APP) and its associations with treatment satisfaction and quality of life (QOL) in schizophrenia patients in China. Method: A total of 4239 patients in 45 nationwide Chinese psychiatric hospitals/centers were interviewed in 2012 in the third cross-sectional study, with the first two having been conducted in 2002 and 2006. Patients' socio-demographic and clinical characteristics, including psychopathology, side effects, satisfaction with treatment and QOL, were recorded using a standardized protocol and data collection procedure. Results: The proportion of APP prescriptions in 2012 was 34.2%, which was significantly higher than the frequency of APP in 2002 (26.1%) and 2006 (26.4%) (p<0.001). Of patients on APP, 91.1% received two antipsychotics, 8.6% received three and 0.3% received four or more antipsychotics. Multiple logistic regression analyses revealed that compared to those on antipsychotic monotherapy, patients on APP and their families had lower satisfaction with treatment, had higher QOL in the mental domain, younger age of onset, more side effects, higher doses of antipsychotics and were more likely to receive first-generation antipsychotics and less likely to receive benzodiazepines (total R-2=0.31, p<0.001). Conclusions: APP was found in about one in three schizophrenia patients. The prevalence of APP seems to have been increasing since 2002. Considering the increased frequency of drug-induced side effects and the patients' and their relatives' dissatisfaction with antipsychotic treatment, further examination of the rationale and appropriateness of APP and its alternatives is warranted.
Objective: We examined the time trends and correlates of clozapine use in schizophrenia patients in China.Method: A total of 14,013 patients with schizophrenia treated in 45 psychiatric hospitals/centers nationwide were interviewed in 2002, 2006 and 2012. Patients' socio-demographic and clinical characteristics including psychopathology, medication side effects, satisfaction with treatment and quality of life (QOL) were recorded in a standardized fashion.Results: Clozapine was used in 32.9% of the whole sample; with corresponding figures of 39.7%, 32.5% and 26.4% in 2002, 2006 and 2012 (p < 0.001). Families of clozapine users had lower satisfaction with treatment than those of the non-clozapine group, without significant differences with respect to patients' treatment satisfaction and mental or physical QOL. In multiple logistic regression analyses, compared to the non-clozapine group, patients on clozapine had an earlier age of onset, longer illness duration, more global illness severity and drug-induced central nervous system, gastrointestinal and other side effects, lower antipsychotic doses, less delusions and hallucinations, more negative symptoms, were more likely male, inpatients, to have a family history of psychiatric disorders, receive treatments in regional centers and receive antipsychotic polypharmacy, but less likely to have health insurance and receive first-generation antipsychotics and benzodiazepines (R-2 = 0.498, p < 0.001).Conclusions: Clozapine was used in one-third of schizophrenia patients in China, with decreasing frequency since 2002. Patients prescribed clozapine had multiple markers of greater global illness severity/chronicity and decreased satisfaction with treatment by the families, but similar QOL and less delusions and hallucinations than patients not prescribed clozapine. (C) 2015 Elsevier B.V. All rights reserved.
目的:探讨根据中国精神障碍分类与诊断标准第3版(CCMD-3)诊断的老年型、老年前期型和混合型阿尔茨海默病(AD)患者间血脂、胰岛素代谢、对氧磷酶-2(PON2)311基因多态性的差异和特点。方法研究对象包括84例AD患者,符合美国国立神经病学、语言障碍和卒中研究所-AD和相关疾病协会( NINCDS-ADRDA)“可能AD”的诊断标准,无痴呆家族史。根据CCMD-3分为老年型、老年前期型和混合型三组,用聚合酶链反应-限制性片段长度多态性分析法检测患者PON2基因311位点多态性,检测血清胆固醇(TC)、甘油三酯(TG)、高密度脂蛋白(HDL)、低密度脂蛋白(LDL)、空腹血糖(FBP)。利用化学发光法测空腹血清胰岛素。利用基础状态法评定胰岛素抵抗性,临床上可使用胰岛素敏感指数(ISI)表达。应用简明智能评定量表(MMSE)、日常生活能力量表(ADL)、Hachinski缺血量表等评定三组患者的认知等临床特征。分析三组间PON2 C311S基因多态性、血清胰岛素、血糖、血脂和神经心理学量表得分的差异。结果老年前期型 AD组的血清 TG和 TC 高于老年型和混合型 AD组( P<0.01)。老年型AD组的HDL水平高于混合型AD组(P<0.01)。老年前期型AD组的血清胰岛素水平高于老年型和混合型AD组(P<0.01)。老年型、老年前期型和混合型AD三组间的PON2311基因型C/C、C/S和S/S分布差异无统计学意义,3组间C和S等位基因频率也无统计学差异。结论老年前期型AD 患者应加强血脂和胰岛素代谢的重视和干预。不同亚型的AD患者PON2基因311位点基因型及等位基因频率未发现显著差异。
Purpose There have been no data about long-term benzodiazepine (BZD) use and its correlates in patients with major depressive disorder (MDD) in China. This study aimed to examine the prevalence of long-term BZD use (more than three months) and its demographic and clinical correlates in Chinese patients with MDD. Design and Methods A total of 1,192 patients with MDD were examined in 10 mental health centers in China. Patients' socio-demographic and clinical characteristics and prescriptions for psychotropic drugs were recorded using a standardized form. Findings A large portion of patients (36.2%) received long-term BZD treatment. Univariate analyses revealed that long-term BZD users were older, poorer, and had more impaired occupational functioning than patients not taking BZDs. Long-term BZD users had fewer psychotic symptoms and took less antipsychotic drugs. In multivariate analyses, long-term BZD use was independently associated with older age and more severe impaired occupational functioning; long-term BZD users were less likely to receive antipsychotic medications and traditional antidepressants (tricyclic antidepressants, tetracyclic antidepressant, and monoamine oxidase inhibitors). Practice Implications Long-term BZD use was common in patients with MDD in China. A host of demographic and clinical factors were independently associated with long-term BZD use.
Aim. To investigate the efficacy and safety of brotizolam in outpatients with insomnia. Methods. This randomized, double-blind, double-dummy, multicenter, controlled trial recruited 253 outpatients randomized to receive either brotizolam (n = 126) or estazolam (n = 127) for 14 days followed by 1 week of follow-up for rebound detection. Sleep Dysfunction Rating Scale (SDRS) and Clinical General Impression Scale were applied for efficacy evaluation. Safety evaluation was based on data regarding vital signs, physical examination, lab tests, ECG and collection of adverse events. Results. Full Analyses Set (FAS) and Safety Set (SS) included data of 251 subjects, with 126 from brotizolam group and 125 from estazolam group. Per Protocol Set (PPS) analysis included data of 235 subjects, with 121 and 114 from each group. Aft er 14 days of treatment, there was no difference with statistical significance between the two groups regarding SDRS total score change from baseline. FAS and PPS analysis showed that the brotizolam is non-inferior to estazolam in efficacy evaluation. There was also no difference with statistical significance regarding rebound rate between brotizolam and estazolam group in FAS. The rate of adverse event in two groups was with no statistically significant difference in SS. Conclusion. Brotizolam is effective and safe in relieving the symptoms of insomnia.
Objective To understand the treatment patterns for bipolar disorders in China in 2006.Methods Based on the economic level,760 out- and in-patients,aged 16 -65 years and meeting the ICD-10 criteria for bipolar disorder were selected from 41 hospitals in 10 provinces and municipalities using the convenient sampling.The investigation was conducted during 22th -28th May,2006,using the retested and revised self-made modified questionnaires.Results ( 1 ) Totally 760 cases including 329 (43.3% ) outpatients and 431 (56.7 % ) inpatients ( male:female =436:318,missing value was 6 ) were recruited in the study.(2) Two thirds of patients experienced elation (n =481,63.3% ),flight of thought (n =436,57.4% ) and hyperactivity ( n =513,67.5% ),and 21.3% patients ( n =162) were bipolar depression.And 7.9% ( n =60) of patients experienced psychotic symptoms,and 6.3% of them ( n =48) manifested suicide idea or behaviors.More inpatients were severe and in the acute phase than outpatients.(3) 88.3% of the patients were treated with mood stabilizer,most frequently prescribed were lithium and valproate.The antipsychotics were used in 78% of all the patients,with the most five medications being clozapine,risperidone,chlorpromazine,quetiapine and haloperidone.18.7% (n =142) of the patients were prescribed antidepressants,the first-line drugs were SSRIs. (4) More inpatients were treated with the antipsychotics and more outpatients with antidepressants.(5) 79.8% of patients (n =606) were treated with two or more kinds of medications,with first-line strategy of combination of antipsychotics and mood stabilizers.(6) Results from the logistic analysis showed that the clinical profile,including experiencing psychotic symptoms,depressive or manic moods played the important role in using the antipsychotics,mood stabilizers or antidepressants treatment.Conclusion The polypharmacy is the mainstream in treatment of bipolar disorder,with the combination of antipsychotics and mood stabilizers being the first-line choice. The prescription pattern for bipolar disorder is correlated to clinical characteristics of patients.
OBJECTIVE:Clozapine is one of the most commonly used antipsychotic drugs in China. To date, few studies have investigated the patterns the prescription of clozapine nationwide. The present study examined these patterns in China in 2006 and identified the demographic and clinical characteristics associated with the use of clozapine.METHODS:Using a standardized protocol and data collection procedure, we surveyed 5,898 patients with schizophrenia in 10 provinces with differing levels of economic development.RESULTS:Overall, clozapine had been prescribed for 31.9% (n=1,883) of the patients; however we found considerable variation among the 10 provinces. The frequency of clozapine use was highest in Sichuan (39.3%) and lowest in Beijing (17.3%). The mean daily dose of clozapine was 210.36±128.72 mg/day, and 25.1% of the patients were treated with clozapine in combination with other antipsychotics. Compared with the group not receiving clozapine, clozapine-user had been treated for longer durations and had experienced a greater number of relapses and hospitalizations. Furthermore, those in the clozapine-user had lower family incomes, were less able to seek psychiatric services, and more likely to be male and have a positive family history of schizophrenia. A multiple logistic regression analysis revealed that age, sex, professional help-seeking behaviors, duration of illness, economic status, educational level, and clinical manifestations were associated with the use of clozapine.CONCLUSION:Clozapine use is common in China. However, use of the antipsychotic varies among provinces, and demographic and clinical factors play important roles in the prescription of clozapine.
目的评价盐酸安非他酮缓释片治疗抑郁症的有效性和安全性,以及治疗该症伴随焦虑的疗效。方法共收集抑郁症患者211例,安非他酮组(治疗组)107例,氟西汀组(对比组)104例。采用多中心、随机、双盲双模拟、阳性药平行对照,剂量固定的研究。受试者分别口服安非他酮片300mg/d或氟西汀片20mg/d,疗程6周。结果治疗6周后,安非他酮组和氟西汀组的HAMD总分减分值分别为(11.75±6.66)、(11.91±5.43)(P=0.843);有效率分别为69.2%、74.0%(P=0.432);疾病严重度和总的进步评分(CGI)相比,P=0.295,0.245;治疗该症伴焦虑的HAMA总分减分评价疗效分别为(8.71±6.15)(、8.75±5.57),P=0.952。以上结果提示各项指标的对比均无统计学差异。不良反应为主要为口干、头昏、恶心。结论盐酸安非他酮缓释片治疗抑郁症和/(或)伴随焦虑的疗效和安全性与盐酸氟西汀相似,认为其可作为一种安全有效的新型抗抑郁药物。
Objective To examine the association among behavioural and psychological symptoms of Alzheimer's disease and insulin resistance,metabolic syndrome(MS).Methods This study included 86 patients with Alzheimer's disease who were divided as two groups according to the diagnostic criteria of metabolic syndrome by Chinese Medical Association Diabetes Branch.That was Non-MS(NMS)group and MS group.All subjects did not have family history of dementia and had fasting levels of glucose,insulin,lipid and blood pressure measured.Insulin resistance was estimated with the Insulin Sensitive Index(ISI).Behavioural and psychological symptoms of AD was assessed by Neuropsychiatric Inventory(NPI).Results The very seldom symptom of both group was elation/euphoria.The most common symptom of MS group was irritability(92.3%)and that of NMS group was aberrant motor behavior(78.5%).There were obviously more symptoms of agitation and irritability in MS group than that in NMS group(P<0.15).Age,systolic blood pressure and low density lipoprotein were associated with NPI score(P<0.15).Fasting insulin and ISI had not obviously difference between two groups.Conclusions Our finding suggest MS influence behavioural and psychological symptoms of Alzheimer's disease.What's more,the finding suggest insulin resistance is not associated with NPI score.
objective To investigate relationship between brain-derived neurotrophic factor (BDNF)gene Va166Met polymorphism and cognitive function in patients with major depressive disorder.Methods One hundred patients with major depressive disorder and 100 healthy volunteers were included.The cognitive function was assessed by a series of neuropsychology tests,and BDNF gene polymorphism was detected.Results (1)In control group,the achievements of all neuropsychology tests except for digit span were not significantly different among ones with different BDNF genotypes(P>0.05).(2)In patient group,the achievements of neuropsychology tests such as WAIS-RC(102.1±1 1.5 vs.92.5±10.2),M-WCST(5.6±1.7 vs.2.9±1.2,36.5±6.0 vs.26.8±5.6),TOH(50.8±9.6 vs.40.4±9.3),time for TMT-A and TMT-B,were significantly better in ones with Val/Val genotype than in ones with Met/Met genotype(P≤0.01).(3)The Val/Val genotype frequency in patients with better cognitive function was higher than that in patients with worse cognitive function,while Met/Met genotype frequency was in the opposite direction(P<0.05 or P<0.01).Conclusion The BDNF gene Va166Met polymorphism is possibly correlated with impairment of cognitive function in patients with major depressive disorder.
OBJECTIVE:To investigate the patterns of antipsychotic use in China and to analyze the factors that influence antipsychotic prescriptions.METHODS:A standardized survey was conducted from May 20 to 24 2002 in five different regions of China with varying economic levels. The patterns of antipsychotic medication use were analyzed in a sample of 4,779 patients with schizophrenia. The survey gathered information on demographic characteristics, clinical profiles, and antipsychotic medications prescribed. Multiple logistic regression was used to analyze factors related to patterns of antipsychotic medication use.RESULTS:A plurality of patients with schizophrenia was treated with clozapine (39%); this was followed by risperidone, sulpride, chlorpromazine, perphenazine, and haloperidol. More than 56.3% of patients were treated with only one atypical antipsychotic. The mean daily dose of chlorpromazine was 365±253 mg (mean±standard deviation), and 6.5% of patients were treated with depot injections of typical antipsychotic medications. A total of 73.7% (n=3,523) of patients with schizophrenia received monotherapy, 24.8% (n=1,183) received two antipsychotics, 1.1% (n=52) received three antipsychotics, and one received four different antipsychotics. Patients often simultaneously received other classes of medications including anticholinergic agents, benzodiazepines, β-blockers, antidepressants, and mood stabilizers. Economic status and clinical symptoms were the main factors that contributed to the patterns of antipsychotic prescription.CONCLUSION:The present study suggests that atypical antipsychotic medications, especially clozapine, are the primary psychiatric treatments of choice in the management of schizophrenia in China. Moreover, the economic status and clinical profile of the patient are the major factors affecting the prescription of antipsychotic medication.
Background: The aim of the study was to evaluate the efficacy and safety of ziprasidone versus risperidone in Chinese subjects with acute exacerbation of schizophrenia.Methods: In patients meeting the Chinese Classification of Mental Disorders criteria for schizophrenia and with a Positive and Negative Syndrome Scale (PANSS) total score >= 60 were randomly assigned to six weeks of double-blind treatment with ziprasidone 40-80 mg twice daily or risperidone 1-3 mg bid, flexibly dosed. Noninferiority was demonstrated if the upper limit of the two-sided 95% confidence interval (CI) for the difference in PANSS total score improvement from baseline in the evaluable population was smaller than the prespecified noninferiority margin of 10 units.Results: The intent-to-treat population comprised 118 ziprasidone-treated and 121 risperidone-treated subjects. Improvement (reduction) from baseline to week 6 in PANSS total score was (-35.6 [95% CI: -38.6, -32.6]) for ziprasidone and (-37.1 [95% CI: -39.9, -34.4]) for risperidone. Noninferiority was demonstrated in the evaluable population with a difference score of 1.5 [95% CI: -2.5, 5.5]. Mean prolactin levels decreased at week 6 compared with baseline for ziprasidone (-3.5 ng/mL), but significantly increased for risperidone (61.1 ng/mL; P < 0.001). More risperidone-treated subjects (14.9%) than ziprasidone-treated subjects (4.2%) reported weight gain >= 7%. Akathisia and somnolence in the ziprasidone group and akathisia and insomnia in the risperidone group were the most common side effects. Treatment-related/treatment-emergent adverse events were reported by 79.7% and 71.1% of ziprasidone-treated and risperidone-treated subjects, respectively.Conclusion: In Chinese subjects, ziprasidone was as effective as risperidone, with less weight gain and less prolactin elevation.
Objective To uncover the antipsychotic drug use patterns for treating schizophrenia in China in 2006, and the developing tendency from 2002 to 2006.Methods Based on the investigation in 2002, the same methods and same hospitals were selected, totally 41 hospitals from 10 provinces and cities.The investigation was conducted during 22th to 28th, May, 2006, using the revised self-made modified questionnaire.Results The total number of sample was 5898, including outpatients (46.0%) and inpatients (54.0% ) ( male: female = 51.6%: 47.4% ).The most common clinical characteristics were the personal and social dysfunction.Antipsychotic medication most frequently prescribed was clozapine (31.7%), subsequently were risperidone (30.5%), sulpiride (14.5%), chlorpromazine (10.8%),perphenazine (9.2%), quetiapine (7.2%) and haloperidol (5.8%) .The mean chlorpromazine equivalent dosage was higher in inpatients than outpatients.In all the patients, 75.6% were treated with mono-pharmacy, in which 72.7% with atypical antipsychotics (while 38.3% with typical drugs), and the percentage of patients with depot antipsychotics was 6.2%.24.4% of the patients were treated with 2 or more than 2 types of antipsychotics.The common concomitant medications were anticholinergic agents,benzodiazepine, β-receptor blockade, antidepressants and mood stabilizers, in order to control the adverse effects or augment the efficacy of antipsychotics.Conclusions Atypical drugs are the mainstream to treat schizophrenia in China, the tendency of antipsychotics prescription pattern matches the development of treatment outcome and treatment techniques for schizophrenia.
探讨血浆同型半胱氨酸(Hcy)浓度与阿尔茨海默病(AD)、血管性痴呆(VD)和轻度认知障碍(MCI)间的相关性.
Objective To evaluate the efficacy and safety of enteric-coted sustained release tablets paroxetine in the treatment of majors depression.Methods A randomized,double-blind,immediate-release paroxetine controlled and multicentre clinical trial was conducted.All subjects(n=418)were randomized to receive either enteric-coted sustained release tablets paroxetine(n=209)or immediate-release paroxetine(n=209)for 8 weeks.The dosage are 25-62.5 mg·d-1 and 20-50 mg·d-1,respectively.Results At the end point,the scores of HAMD-17 decreased from the baseline were(14.8±7.0)and(15.1±6.7),and the least square means of HAMD-17 changes were-14.9 and-15.2,respectively.There were no significance between two groups.Upper limit of 95% CI of differences between two groups was under non-inferiority test with the criterion of 2.5(P=0.64).The result showed non-inferiority of enteric-coted sustained release tablets paroxetine.The total adverse effects incidence rate of the two groups were not significant.Withdrawal/suspend rate due to gastrointestinal adverse effects were 3.4% and 7.3%.The enteric-coted sustained release tablets paroxetine group had lower gastrointestinal side effects.Conclusion The enteric-coted sustained release tabletsd paroxetine had similar therapeutic effects with immediate-release paroxetine in the treatment of major depression.The enteric-coted sustained release tablets paroxetine had less gastrointestinal side effects.
Objective To uncover the antidepressants drug use patterns for treating depression in China in 2006, and the developing tendency for past 4 years. Methods Based on economic levels in different provinces and the convenient sampling, totally 41 hospitals from 10 provinces and cities were selected out. The investigation was conducted during May 22th -28th, 2006, using the revised self-made questionnaire. Results The total number of the sample was 1354, including outpatients (68.0% ) and with pharmacotherapy, and the antidepressants most frequently prescribed were paroxetine (24.4% of the 1354 patients), fluoxetine (20.3% ), venlafaxine (19.5%), citalopram (11.0%), sertraline (6.3% ),and mirtazapine (4.1% ), while 219 patients ( 17.1% ) were treated with TCAs. 62.3% of patients were treated with SSRIs, and most of them administered monotherapy. The frequency of benzodiazepine,antipsychotics and mood stabilizers used were 43.6%, 20.8% and 6.5%, respectively. Comparing to the outpatients, the frequency to use the benzodiazepine and antipsychotics for the inpatients was higher (P < 0.05). And more patients in acute phase used benzodiazepine than those who were in maintenance phase (P < 0.01 ). Conclusion Novel antidepressants are the mainstream to treat patients with depression in China, the tendency of antidepressants prescription pattern matches the development of treatment outcome and treatment techniques for depression.
Objective:To explore the value of polygraph test for identifying malingered mental disorders in psychiatric testimony.Methods:According to the Chinese Classification and Diagnostic Criteria for Mental Disorders,the 3rd edition(CCMD-3),29 patients with definite mental disorders and 16 cases who were considered as malingering received polygraph test.All subjects were assessed with the control question test by polygraph(Type PG-10).The value of polygraph for identifying malingered mental disorders was evaluated by comparing the difference in lying rates between the two groups.The t-test and Chi-square test were used to analyze these data.Results:The lying rates of the two target questions in malingering group were 93.7%(15/16)and 56.2%(9/16)respectively,that in the mental disorders group was 0(0/29).The differences between the two groups were significant.The sensitivity and specificity of the test were 93.7% and 100% respectively.Conclusion:There were great sensitivity and specificity to differentiate malingering in psychiatric testimony by polygraph.But it is necessary to collect more subjects to test in the future.
CONTEXT:Antipsychotic drugs are limited in their ability to improve the overall outcome of schizophrenia. Adding psychosocial treatment may produce greater improvement in functional outcome than does medication treatment alone.OBJECTIVE:To evaluate the effectiveness of antipsychotic medication alone vs combined with psychosocial intervention on outcomes of early-stage schizophrenia.DESIGN:Randomized controlled trial.SETTING:Ten clinical sites in China.PARTICIPANTS:Clinical sample of 1268 patients with early-stage schizophrenia treated from January 1, 2005, through October 31, 2007. Intervention Patients were randomly assigned to receive antipsychotic medication treatment only or antipsychotic medication plus 12 months of psychosocial intervention consisting of psychoeducation, family intervention, skills training, and cognitive behavior therapy administered during 48 group sessions.MAIN OUTCOME MEASURES:The rate of treatment discontinuation or change due to any cause, relapse or remission, and assessments of insight, treatment adherence, quality of life, and social functioning.RESULTS:The rates of treatment discontinuation or change due to any cause were 32.8% in the combined treatment group and 46.8% in the medication-alone group. Comparisons with medication treatment alone showed lower risk of any-cause discontinuation with combined treatment (hazard ratio, 0.62; 95% confidence interval, 0.52-0.74; P < .001) and lower risk of relapse with combined treatment (0.57; 0.44-0.74; P < .001). The combined treatment group exhibited greater improvement in insight (P < .001), social functioning (P = .002), activities of daily living (P < .001), and 4 domains of quality of life as measured by the Medical Outcomes Study 36-Item Short Form Health Survey (all P < or = .02). Furthermore, a significantly higher proportion of patients receiving combined treatment obtained employment or accessed education (P = .001).CONCLUSION:Compared with those receiving medication only, patients with early-stage schizophrenia receiving medication and psychosocial intervention have a lower rate of treatment discontinuation or change, a lower risk of relapse, and improved insight, quality of life, and social functioning.TRIAL REGISTRATION:clinicaltrials.gov Identifier: NCT00654576.