Trial of aripiprazole in the treatment of first-episode schizophrenia

Aims:  Aripiprazole is an atypical antipsychotic indicated for the treatment of adult patients with schizophrenia. It is effective and well tolerated in patients with schizophrenia or schizoaffective disorder. The aim of the present study was to investigate therapeutic efficacy and tolerability of aripiprazole in patients with first-episode schizophrenia.
Methods:  Twenty-one patients meeting the DSM-IV criteria for schizophrenia were recruited. The Positive and Negative Symptom Scale (PANSS) and the Clinical Global Impressions Scale (CGI) were completed at the beginning of the study and again after 1, 2, 4, and 8 weeks of aripiprazole treatment. Side-effects were analyzed using the Udvalg for Kliniske Undersøgelser Side-Effect Rating Scale. Weight was checked at each testing session, and prolactin levels were measured at baseline and after 8 weeks of aripiprazole treatment.
Results:  Significant benefits were observed after the first week of treatment. After 1 week of aripiprazole treatment, subscale and total scores on the PANSS had decreased significantly. This significant decrease was maintained throughout the study period. The mean score of CGI severity was also significantly different after 2 weeks of aripiprazole administration when compared to baseline score, and the significance was maintained thereafter. Weight did not significantly change after aripiprazole administration. Although mean prolactin level was decreased at 8 weeks, the difference was not significant.
Conclusions:  Aripiprazole is an effective and well-tolerated antipsychotic agent in patients with first-episode schizophrenia. Further investigations with larger samples are needed.     

Efficacy and safety of aripiprazole and haloperidol versus placebo in patients with schizophrenia and schizoaffective disorder

BACKGROUND: Aripiprazole is an investigational agent for treating schizophrenia that has a novel pharmacologic profile. The present study investigated the efficacy, safety, and tolerability of aripiprazole and haloperidol compared with placebo. METHOD: A 4-week, double-blind, randomized study, conducted at 36 U.S. centers between July 1997 and June 1998, compared aripiprazole (15 mg/day, 30 mg/day) to placebo, with haloperidol (10 mg/day) as an active control. Fixed doses of each agent were administered from day 1 throughout the study. A total of 414 patients with a primary DSM-IV diagnosis of schizophrenia or schizoaffective disorder were randomized. Efficacy measures included the Positive and Negative Syndrome Scale (PANSS) total, PANSS positive, PANSS negative, PANSS-derived Brief Psychiatric Rating Scale (BPRS) core, Clinical Global Impressions (CGI)-Severity of Illness, and mean CGI-Improvement scores. Safety and tolerability evaluations included extrapyramidal symptoms (EPS), weight gain, serum prolactin level, and QTc interval. RESULTS: Both doses of aripiprazole and haloperidol, 10 mg, produced statistically significant (p < or = .05) improvements from baseline in PANSS total, PANSS positive, PANSS-derived BPRS core, and CGI-Severity scores and significantly lower CGI-Improvement scores at endpoint, compared with placebo. Aripiprazole, 15 mg, and haloperidol, 10 mg, significantly improved PANSS negative score compared with placebo. Both aripiprazole doses and haloperidol separated from placebo for PANSS total scores at week 2. Unlike haloperidol, aripiprazole was not associated with significant EPS or prolactin elevation at endpoint compared with placebo. There were no statistically significant differences in mean changes in body weight across the treatment groups versus placebo, and no patients receiving aripiprazole experienced clinically significant increases in QTc interval. CONCLUSION: Aripiprazole, effective against positive and negative symptoms, is a safe and well-tolerated potential treatment for schizophrenia and schizoaffective disorder.     

Aripiprazole,an antipsychotic with a novel mechanism of action,and risperidone vs placebo in patients with schizophrenia and schizoaffective disorder

BACKGROUND: Aripiprazole is a dopamine D2 receptor partial agonist with partial agonist activity at serotonin 5HT1A receptors and antagonist activity at 5HT2A receptors. This multicenter trial examined the efficacy, safety, and tolerability of aripiprazole in patients with acute exacerbation of schizophrenia or schizoaffective disorder. METHODS: In this 4-week double-blind study, 404 patients were randomized to 20 mg/d (n = 101) or 30 mg/d (n = 101) of aripiprazole, placebo (n = 103), or 6 mg/d of risperidone (n = 99). Efficacy assessments included Positive and Negative Syndrome Scale (PANSS) scores and Clinical Global Impression scores. Safety and tolerability evaluations included extrapyramidal symptoms and effects on weight, prolactin, and corrected QT (QTc) interval. RESULTS: Aripiprazole (20 and 30 mg/d) and risperidone (6 mg/d) were significantly better than placebo on all efficacy measures. Separation from placebo occurred at week 1 for PANSS total and positive scores with aripiprazole and risperidone and for PANSS negative scores with aripiprazole. There were no significant differences between aripiprazole and placebo in mean change from baseline in the extrapyramidal symptom rating scales. Mean prolactin levels decreased with aripiprazole but significantly increased 5-fold with risperidone. Mean change in QTc interval did not differ significantly from placebo with any active treatment group. Aripiprazole and risperidone groups showed a similar low incidence of clinically significant weight gain. CONCLUSIONS: Aripiprazole is effective, safe, and well tolerated for the positive and negative symptoms in schizophrenia and schizoaffective disorder. It is the first non-D2 receptor antagonist with clear antipsychotic effects and represents a novel treatment development for psychotic disorders.     

Efficacy of aripiprazole against hostility in schizophrenia and schizoaffective disorder: data from 5 double-blind studies

OBJECTIVE: The objective was to determine the effects of aripiprazole on hostility. METHOD: A total of 1476 patients diagnosed with DSM-IV schizophrenia or schizoaffective disorder were the subjects in 5 short-term, double-blind studies comparing aripiprazole with placebo; 3 of these studies also included a comparison with haloperidol. The studies were conducted between December 1993 and January 2001. The Positive and Negative Syndrome Scale (PANSS) was the principal outcome measure in these studies. To determine the effect of aripiprazole on hostility, post hoc analyses of the hostility item from the PANSS were conducted for the first 4 weeks of treatment. RESULTS: Aripiprazole was superior to placebo and not significantly different from haloperidol in reducing hostility. CONCLUSION: Aripiprazole is an effective treatment for hostility in patients with schizophrenia or schizoaffective disorder.     

Aripiprazole for the prevention of relapse in stabilized patients with chronic schizophrenia: a placebo-controlled 26-week study

BACKGROUND: Aripiprazole is a novel antipsychotic for the management of schizophrenia. This study investigated the efficacy, safety, and tolerability of aripiprazole in preventing relapse in adult chronic schizophrenia patients experiencing ongoing stable symptomatology. METHOD: In this 26-week, randomized, double-blind, placebo-controlled, parallel-group, multi-center study, 310 patients with DSM-IV schizophrenia (mean Positive and Negative Syndrome Scale [PANSS] total score = 82) were randomly assigned to receive a once-daily fixed dose of aripiprazole, 15 mg, or placebo. The primary outcome measure was time to relapse following randomization. Secondary objectives were to assess the efficacy, safety, and tolerability of aripiprazole, 15 mg, compared with placebo, in the study population. The study was conducted between Dec. 21, 2000, and Aug. 20, 2001. RESULTS: The time to relapse following randomization was significantly (p < .001) longer for aripiprazole compared with placebo. More patients relapsed with placebo (N = 85; 57%) than aripiprazole (N = 50; 34%); the relative risk of relapse for the aripiprazole group was 0.59 (p < .001). Aripiprazole was significantly superior to placebo from baseline to endpoint in PANSS total, PANSS positive, PANSS-derived Brief Psychiatric Rating Scale, and Clinical Global Impressions-Severity of Illness scale (CGI-S) scores and demonstrated significantly better mean Clinical Global Impressions-Global Improvement scale scores (p < or = .01 for all comparisons except CGI-S: .01 < p < or = .05). Aripiprazole was well tolerated, with no evidence of marked sedation and no evidence of hyperprolactinemia or prolonged heart rate-corrected QT interval (QTc). Extrapyramidal symptoms were comparable in the aripiprazole and placebo groups. Modest mean weight loss at endpoint was evident in both groups. CONCLUSION: Aripiprazole, 15 mg once daily, is an effective, well-tolerated treatment for prevention of relapse in patients with chronic, stable schizophrenia.     

The impact of insight on functioning in patients with schizophrenia or schizoaffective disorder receiving risperidone long-acting injectable

This post hoc analysis explored the role of insight as a mediator of functioning in a 52-week, double-blind, international trial of 323 patients with schizophrenia or schizoaffective disorder receiving risperidone long-acting injectable. Measures included the Positive and Negative Syndrome Scale (PANSS) insight item, PANSS factors, Clinical Global Impressions-Severity (CGI-S), Strauss-Carpenter Levels of Functioning (LOF), Personal and Social Performance (PSP) scale, and a cognitive test battery. Correlation/regression analyses examined associations between demographic and clinical characteristics, including insight, and functional measures. Insight scores correlated significantly with CGI-S, PANSS subscales, PSP, LOF, and several cognitive measures. Regression models demonstrated that changes in insight, changes in negative symptoms, and study duration were significantly associated with PSP and LOF total change scores. Findings identified important variables to consider for intervention to improve functioning in schizophrenia.     

Olanzapine vs risperidone in the management of schizophrenia: a randomized double-blind trial in Australia and New Zealand

Improved drug therapy for schizophrenia may represent the best strategy for reducing the costs of schizophrenia and the recurrent chronic course of the disease. Olanzapine and risperidone are atypical antipsychotic agents developed to meet this need. We report a multicenter, double-blind, parallel, 30-week study designed to compare the efficacy, safety, and associated resource use for olanzapine and risperidone in Australia and New Zealand. The study sample consisted of 65 patients who met DSM-IV criteria for schizophrenia, schizoaffective disorder, or schizophreniform disorder. Olanzapine-treated patients showed a significantly greater reduction in Positive and Negative Syndrome Scale (PANSS) total, Brief Psychiatric Rating Scale (BPRS) total, and PANSS General Psychopathology scores at endpoint compared to the risperidone-treated patients. Response rates through 30 weeks showed a significantly greater proportion of olanzapine-treated patients had achieved a 20% or greater improvement in their PANSS total score compared to risperidone-treated patients. Olanzapine and risperidone were equivalent in their improvement of PANSS positive and negative scores and Clinical Global Impression-Severity of Illness scale (CGI-S) at endpoint. Using generic and disease-specific measures of quality of life, olanzapine-treated patients showed significant within-group improvement in most measures, and significant differences were observed in favor of olanzapine over risperidone in Quality of Life Scale (QLS) Intrapsychic Foundation and Medical Outcomes Study Short Form 36-item instrument (SF-36) Role Functioning Limitations-Emotional subscale scores. Despite the relatively small sample size, our study suggests that olanzapine has a superior risk:benefit profile compared to risperidone.     

阿立哌唑与利培酮治疗精神分裂症的疗效及安全性对照研究

目的 探讨阿立哌唑治疗急性精神分裂症的疗效及安全性.方法 人组首次发病或症状急性恶化的精神分裂症患者200例,随机分为阿立哌唑组和利培酮组各100例,观察时间为6周.于基线及治疗第1,2,4,6周末,采用阳性和阴性症状量表(PANSS)评定疗效,采用治疗中需处理的不良反应症状量表、血生化指标和心电图的改变评价治疗的安全性.最终纳入分析197例(阿立哌唑组98例,利培酮组99例).结果 (1)阿立哌唑组自治疗第1周末(除阴性症状分外)、利培酮组自治疗第4周末,PANSS阳性、阴性症状分、精神病理症状分和总分均明显下降(P＜0.05或P＜0.01).治疗第6周末,阿立哌唑组PANSS阳性症状分(12.5 ±6.3)分,阴性症状分(14.8±7.6)分,精神病理症状分(27.4±9.9)分,总分(54.7±21.3)分,与基线分[分别为(22.1±6.9)分,(21.8±8.6)分,(41.1±10.1)分,(85.1±18.6)分]的差异均有统计学意义(P均＜0.01),且疗效优于利培酮组(P＜0.01).(2)治疗第6周末,阿立哌唑组治愈35例(36%),显著好转31例(32%),好转14例(14%),症状无显著变化15例(15%),恶化3例(3%);治愈率为36%,显效率为67%;有效率为82%,高于利培酮组(74%).(3)6周的观察期中,未发现阿立哌唑导致的体质量明显增加及心电图明显改变.结论 阿立哌唑对急性精神分裂症有良好的疗效,而且起效较迅速,安全性较好.     

阿立哌唑与利培酮治疗住院精神分裂症患者的对照研究

目的探讨阿立哌唑与利培酮治疗住院精神分裂患者的疗效及安全性。方法将60例住院精神分裂症患者随机分为阿立哌唑组与利培酮组,每组30例,疗程8周,分别于治疗前及治疗后的第2、4、8周进行PANSS、SANS和TESS评定。结果两组疗效比较差异无统计学意义（P〉0.05）;治疗前后两组SANS各因子评分差异有统计学意义（P〈0.05或P〈0.01）;治疗4、8周时,阿立哌唑组意志缺乏、注意障碍两项因子分与利培酮组比较,差异有统计学意义（P〈0.05或P〈0.01）,而其他因子评分两组间差异则无统计学意义（P〉0.05）;阿立哌唑几乎不导致体重增加及月经紊乱等不良反应。结论阿立哌唑与利培酮对阴性症状均有较好疗效,但前者对意志缺乏及注意障碍的改善更明显,且不良反应较少,阿立哌唑是治疗以阴性症状为主的精神分裂症理想药物。     

A prospective, multicenter, randomized, parallel-group, open-label study of aripiprazole in the management of patients with schizophrenia or schizoaffective disorder in general psychiatric practice: Broad Effectiveness Trial With Aripiprazole (BETA)

OBJECTIVE: BETA was designed to evaluate the overall effectiveness of aripiprazole in patients with schizophrenia or schizoaffective disorder treated in a general psychiatry outpatient practice setting. METHODS: In this 8-week, multicenter, open-label study, 1,599 outpatients with schizophrenia or schizoaffective disorder were randomly assigned to receive either aripiprazole (n=1,295) or another antipsychotic medication (safety control [SC] group; n=304). Aripiprazole was initiated at 15 mg/d with the option to adjust between 10-30 mg/d. The SC medication was specifically selected for each patient by the clinician and dosed according to prescribing guidelines for that medication. The primary effectiveness measure was the Clinical Global Impression-Improvement (CGI-I) score of the aripiprazole group at study end point. Secondary measures included response rates and preference of medicine (POM) ratings by patients and caregivers. RESULTS: Sixty-five percent of aripiprazole patients completed the study. The mean aripiprazole dose at end point was 19.9 mg/d, with approximately 39% of patients starting and remaining at 15 mg/d. At end point, the mean CGI-I score of 2.77 demonstrated that aripiprazole was minimally to moderately effective; the mean CGI-I score for the SC group was 3.59 indicating minimally effective to no change. Fifty-three percent of aripiprazole patients responded to treatment (CGI-I score of 1 or 2; last-observation-carried-forward [LOCF]), and approximately 71% of patients and caregivers rated aripiprazole as better than the prestudy medication on the POM (LOCF). Incidence and severity of adverse events (AEs) were similar to those reported in double-blind, randomized, placebo-controlled aripiprazole clinical trials. The most frequent AE in the aripiprazole group was insomnia (24%). CONCLUSIONS: Aripiprazole was effective for the treatment of schizophrenia and schizoaffective disorder in a general psychiatry outpatient practice setting. Overall, aripiprazole was found to be effective by the treating clinician and well accepted by patients and caregivers over the 8-week treatment course.     

Efficacy and tolerability of ziprasidone versus risperidone in patients with acute exacerbation of schizophrenia or schizoaffective disorder: an 8-week, double-blind, multicenter trial

BACKGROUND: More head-to-head comparisons of antipsychotics are needed to discern the relative efficacy and safety profiles of these compounds. Thus, we compared ziprasidone and risperidone in patients with acute exacerbation of schizophrenia or schizoaffective disorder. METHOD: Patients with DSM-III-R acute exacerbation of schizophrenia or schizoaffective disorder were randomly assigned to double-blind ziprasidone 40 to 80 mg b.i.d. (N = 149) or risperidone 3 to 5 mg b.i.d (N = 147) for 8 weeks. Primary efficacy measures included Positive and Negative Syndrome Scale (PANSS) total score and Clinical Global Impressions-Severity of Illness scale (CGI-S) score; secondary measures included scores on the PANSS negative sub-scale, CGI-Improvement scale (CGI-I), and PANSS-derived Brief Psychiatric Rating Scale (BPRSd) total and core items. Safety assessments included movement disorder evaluations, laboratory tests, electrocardiography, vital signs, and body weight. Efficacy analyses employed a prospectively defined Evaluable Patients cohort. Treatment equivalence was conferred if the lower limit of the 95% confidence interval of the ziprasidone/risperidone ratio of least-squares mean change from baseline was > 0.60. Data were gathered from August 1995 to January 1997. RESULTS: Equivalence was demonstrated in PANSS total scores, CGI-S scores, PANSS negative subscale scores, BPRSd total and core item scores, and PANSS total and CGI-I responder rates. Both agents were well tolerated. Risperidone exhibited a significantly higher Movement Disorder Burden (MDB) score (p < .05) and higher incidences of prolactin elevation and clinically relevant weight gain. However, compared with current recommendations, study dosing may have been high for some risperidone-treated patients (mean dose = 7.4 mg/day) and low for some ziprasidone-treated patients (mean dose = 114.2 mg/day). CONCLUSION: Both agents equally improved psychotic symptoms, and both were generally well tolerated, with ziprasidone demonstrating a lower MDB score and less effect on prolactin and weight than risperidone.     

A 64-week, multicenter, open-label study of aripiprazole effectiveness in the management of patients with schizophrenia or schizoaffective disorder in a general psychiatric outpatient setting

Objective

To evaluate the overall long-term effectiveness of aripiprazole in patients with schizophrenia in a general psychiatric practice setting in Taiwan.

Methods

This was a prospective, open-label, multicenter, post-market surveillance study in Taiwanese patients with a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnosis of schizophrenia or schizoaffective disorder requiring a switch in antipsychotic medication because current medication was not well tolerated and/or clinical symptoms were not well controlled. Eligible patients were titrated to aripiprazole (5-30 mg/day) over a 12-week switching phase, during which their previous medication was discontinued. Patients could then enter a 52-week, long-term treatment phase. Aripiprazole was flexibly dosed (5-30 mg/day) at the discretion of the treating physicians. Efficacy was assessed using the Clinical Global Impression scale Improvement (CGI-I) score, the Clinical Global Impression scale Severity (CGI-S) score, The Brief Psychiatry Rating Scale (BPRS), and the Quality of Life (QOL) scale, as well as Preference of Medicine (POM) ratings by patients and caregivers. Safety and tolerability were also assessed.

Results

A total of 245 patients were enrolled and switched from their prior antipsychotic medications, and 153 patients entered the 52-week extension phase. In all, 79 patients (32.2%) completed the study. At week 64, the mean CGI-I score was 3.10 and 64.6% of patients who showed response. Compared to baseline, scores of CGI-S, QOL, and BPRS after 64 weeks of treatment also showed significant improvements. At week 12, 65.4% of subjects and 58.9% of caregivers rated aripiprazole as better than the prestudy medication on the POM. The most frequently reported adverse events (AEs) were headache, auditory hallucinations and insomnia. A total of 13 patients (5.3%) discontinued treatment due to AEs. No statistically significant changes were noted with respect to fasting plasma glucose, lipid profile, body weight, and body mass index after long-term treatment with aripiprazole.

Conclusions

Although the discontinuation rate was high, aripiprazole was found to be effective, safe and well tolerated in the long-term treatment of Taiwanese patients with schizophrenia who continued to receive treatment for 64 weeks.     

阿立哌唑与奎硫平治疗首发精神分裂症对照分析

目的:评价阿立哌唑与奎硫平对治疗首发精神分裂症患者的有效性和安全性。方法:对85例首发精神分裂症患者,随机分为阿立哌唑组及奎硫平组进行治疗,分别在治疗前及治疗2,4,8周末采用阳性与阴性症状量表(PANSS)评定临床疗效,用治疗中出现的症状量表(TESS)评定药物不良反应。结果:阿立哌唑能有效治疗首发精神分裂症的阳性症状及阴性症状,疗效与奎硫平相当,不良反应较奎硫平更少。结论:阿立哌唑是一种有效而安全的新型抗精神病药。     

阿立哌唑替换传统和其他非典型抗精神病药物的临床研究

目的 探讨用阿立哌唑替换传统和其他非典型抗精神病药物治疗的疗效、耐受性和安全性。方法 对118例使用传统和其他非典型抗精神病药治疗的精神分裂症患者换用阿立哌唑治疗8周，用PANSS、CGI—GI、TESS作为评估工具，于换药前及换药后的第1、2、4、8周进行评分，然后对换药前后的疗效、耐受性和安全性进行比较。结果 所有患者都顺利地从原来的药物换用了阿立哌唑治疗，换用阿立哌唑后PANSS总分、阴性症状以及CGI疾病严重程度均得到改善，P〈0．05或P〈0．01。嗜睡、EPS、体重增加、月经紊乱、静坐不能等副反应显著减少。结论 阿立哌唑替换传统和其他非典型抗精神病药物，可以提高疗效，减少副反应，显示了良好的疗效、耐受性和安全性，有利于长期服药维持治疗。     

阿立哌唑、利培酮及氯丙嗪对精神分裂症疗效及认知功能的影响

目的探讨非经典抗精神病药阿立哌唑、利培酮及传统抗精神病药氯丙嗪治疗精神分裂症的疗效及对认知功能的影响。方法将148例符合CCMD-3诊断标准的精神分裂症病人随机分为阿立哌唑组（48例）、利培酮组（52例）和氯丙嗪组（48例），观察12周，分别于治疗前及治疗后4、8、12周采用阳性症状与阴性症状量表（PANSS）、不良反应量表（TESS）评定疗效和不良反应；治疗前及治疗后12周采用韦氏成人记忆测检（WMS）及威斯康星卡片分类测验（WCST）测定。结果与治疗前比较，三组治疗后12周PANSS总分及各因子分显著下降（P〈0．01），但三组之间无显著差异；利培酮、氯丙嗪组的不良反应发生率高于阿立哌唑组（P〈0．05），主要表现为肌强直、震颤等锥体外系等不良反应；阿立哌唑、利培酮组WMS和WCST评分均有显著改善，而氯丙嗪组治疗前后则无差异。结论阿立哌唑、利培酮及氯丙嗪治疗精神分裂症均有效，且疗效相当，阿立哌唑所致锥体外系不良反应较少，阿立哌唑、利培酮对认知功能有改善作用，而氯丙嗪则对认知功能无影响。     

阿立哌唑与利培酮治疗首发精神分裂症的对照研究

目的比较阿立哌唑与利培酮治疗首发精神分裂症的疗效和安全性。方法将70例首发精神分裂症患者随机分为阿立哌唑组(n=35)和利培酮组(n=35)进行治疗,疗程8周。在治疗前及治疗后第1、2、4及8周末采用阳性阴性症状量表(PANSS)及不良反应量表(TESS)评定其疗效及药物不良反应。结果阿立哌唑的治疗有效率为64.7%,利培酮的治疗有效率为63.6%,两组疗效差异无显著性。两药均无严重不良反应,但阿立哌唑的肌强直、静坐不能以及泌乳、月经紊乱的发生率明显低于利培酮。结论阿立哌唑与利培酮治疗首发精神分裂症均有效,前者不良反应更少、更安全。     

A prospective, multicentre, open-label study to evaluate the effectiveness of aripiprazole in the treatment of a broad range of patients with schizophrenia

PurposeThe aim of this study is to evaluate the effectiveness of 12-week treatment with aripiprazole in a broad range of patients suffering from schizophrenia by using a variety of physicians, caregivers and patients scales.Subjects and methodsA total of 361 in- or outpatients who met Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for schizophrenia received open-label aripiprazole (10–30 mg per day) in this 12-week, prospective, multicentre, uncontrolled study. The primary endpoint was the Clinical Global Impression-Improvement (CGI-I) scale which measured effectiveness of study medication, including efficacy, safety and tolerability. A variety of physician-, patient- and caregiver-rated parameters were measured to gain a complete view of the effectiveness of aripiprazole.ResultsThe effectiveness of aripiprazole treatment was demonstrated in a broad range of schizophrenia patients (CGI-I score of 3.0; 95% confidence interval: 2.8, 3.2: last observation carried forward [LOCF]) as the upper bound of the 95% CI was less than 4 (score of “no change”). Both patient and caregiver PGI-I scores (LOCF: 95% CI: 2.79, 3.09 and, 95% CI: 2.74, 3.17, respectively) corroborate this finding. Aripiprazole had a positive effect on disease severity by study end, as assessed by an increase of the (physician-rated) CGI-S scores, with 57.3% of patients having improved disease, one-third maintaining their condition (30.8%) and 11.3% with worsening symptoms (LOCF). The Investigator Assessment Questionnaire (IAQ) showed a great improvement (>50% of patients). Patients reported significantly improved quality of life and overall, 71% of patients and 67% of caregivers preferred aripiprazole to their previous antipsychotic medication (LOCF; P < 0.0001 over time).ConclusionAripiprazole was effective in a broad range of patients with schizophrenia.     

阿立哌唑与氯氮平治疗首发精神分裂症对照研究

目的比较阿立哌唑与氯氮平治疗首发精神分裂症的疗效及安全性。方法将63例首发精神分裂症患者随机分为阿立哌唑组(n=32)和氯氮平组(n=31)进行治疗,疗程8周。采用PANSS量表和TESS量表评定疗效和不良反应。结果两组疗效差异无显著性(P>0.05),阿立哌唑不良反应显著少于氯氮平(P<0.01)。结论阿立哌唑与氯氮平治疗首发精神分裂症均有效,前者不良反应少,安全性高。     

阿立哌唑治疗精神分裂症临床观察

以阿立哌唑治疗精神分裂症患者40例,报告如下。1对象和方法为我院2004年10月至2005年3月门诊患者,符合中国精神障碍分类与诊断标准第3版精神分裂症或分裂样精神病诊断标准;年龄15~59岁;排除器质性疾病,药物或酒依赖,妊娠、哺乳期妇女;阳性与阴性症状量表(PANSS)总分≥60分。共4     

Oxcarbazepine add-on in the treatment of refractory bipolar disorder

Objective:  To assess the effectiveness and safety of oxcarbazepine (OXC) in bipolar disorder (BD) and related conditions.
Methods:  We reviewed medical records of patients given OXC treatment between March 2003 and March 2005 at the University of British Columbia Hospital. Response to treatment was assessed retrospectively using the Clinical Global Impression of Severity (CGI-S), and the Clinical Global Impression of Improvement (CGI-I) scales.
Results:  OXC was prescribed to 15 patients with bipolar I (n = 12), bipolar II (n = 2) and schizoaffective (n = 1) disorder who presented with depression (n = 9), mania (n = 3), hypomania (n = 1), or mixed state (n = 2). Six patients had Axis II diagnoses and 10 patients had a family history of mood disorders. Psychiatric co-morbidity was found in four patients. The mean daily dose of OXC was 775 ± 556.11 mg/day and the mean duration of follow-up was 31.60 ± 41.51 weeks. The OXC add-on led to a significant reduction in symptoms as indicated by reduction in CGI-S scores at 1 and 2 months. Nine of 12 patients at 1 month and seven of 14 at 1 or 2 months were much or very much improved on CGI-I scale. One patient (7%) developed hyponatremia. Six patients (40%) experienced no side effects and three patients (20%) stopped the medication because of side effects.
Conclusion:  OXC was effective and well-tolerated in refractory BD and schizoaffective disorder. These preliminary data are promising but controlled studies are needed to confirm its efficacy in refractory BD.