[Show abstract][Hide abstract] ABSTRACT: Background:
This study is a pre-registration trial of generic duloxetine that was approved by the China Food and Drug Administration (approval number: 2006L01603).
Compare the treatment efficacy and safety of generic duloxetine to that of paroxetine in patients with major depressive disorders (MDD).
This was a double-dummy, double-blind, multicenter, positive drug (paroxetine), parallel randomized controlled clinical trial. The 299 patients with MDD recruited for the study were randomly assigned to use duloxetine (n=149; 40-60 mg/d) or paroxetine (n=150; 20 mg/d) for 8 weeks. The Hamilton Depression rating scale (HAMD-17) was administered at baseline and 1, 2, 4, 6, and 8 weeks after starting treatment. Remission was defined as a HAMD-17 score below 8 at the end of the trial, and treatment effectiveness was defined as a decrease in baseline HAMD-17 score of at least 50% by the end of the trial. Safety was assessed based on the reported prevalence and severity of side effects and changes in laboratory and electrocardiographic findings. Three patients in the duloxetine group dropped out before starting medication, so results were analyzed using a modified intention-to-treat (ITT) method with 146 in the experimental group and 150 in the control group.
Both groups experienced 29 dropouts during the 8-week trial. HAMD-17 scores decreased significantly from baseline throughout the trial in both groups. Based on the ITT analysis, at the end of the trial there was no significant difference between the duloxetine group and the paroxetine group in effectiveness (67.1% v. 71.3%, X(2)=0.62 p=0.433), remission rate (41.1% v. 51.3%, X(2)=3.12, p=0.077), or in the incidence of side effects (56.8% v. 54.7%, X(2)=0.14, p=0.705).
Generic duloxetine is as effective and safe as paroxetine in the acute treatment of patients with MDD who seek care at psychiatric outpatient departments in China.
Preview · Article · Nov 2015 · Shanghai Archives of Psychiatry
[Show abstract][Hide abstract] ABSTRACT: Objective:
Antipsychotics, such as aripiprazole and risperidone, are often used to treat individuals with schizophrenia. The efficacy as well as safety of aripiprazole in Western populations has been described. The objective of this study is to investigate the efficacy, safety, and tolerability of aripiprazole and risperidone in Chinese Han schizophrenia subjects in mainland China.
The 6-week, double-blind, randomized, parallel study was conducted in 5 medical centers in mainland China from November 2007 to March 2011. A total of 279 subjects with a primary DSM-IV diagnosis of schizophrenia were randomly assigned (with a randomization ratio of 1:1) to aripiprazole (n=139) or risperidone (n=140). Efficacy measurements included the Positive and Negative Syndrome Scale (PANSS) total, positive, negative and general psychopathology subscale scores, and Clinical Global Impressions-Severity of Illness (CGI-S), and Improvement scale scores. Extrapyramidal symptoms (EPS), weight gain, serum prolactin level, QTc interval, and self-reported adverse events were also assessed as measures of safety and tolerability.
Both the aripiprazole and risperidone groups showed statistically significant improvement of PANSS total, positive, negative, general psychopathology subscale scores, and CGI-S scores from baseline to the endpoint (all p<0.01). Significant improvement was noted in the first week for both treatment groups. There were no significant differences in efficacy measurements between the two treatment groups. Mean change of PANSS total scores from baseline to the endpoint was -26.8±18.1 for aripiprazole and -30.0±17.7 for risperidone, (p=0.1475). The responder rate was 71% (n=99) and 76% (n=107) for aripiprazole and risperidone, respectively, (p=0.323). The incidences of EPS were similar in the aripiprazole (25%, n=35) and risperidone groups (24%, n=34), respectively (p=0.757). No clinically meaningful effects on QTc interval, QRS duration, or PR interval were observed in either treatment groups. However, the incidence of clinically significant weight gain (p=0.0118) and hyperprolactinemia (p<0.001) in the aripiprazole group was significantly lower than in the risperidone group.
The study demonstrated that aripiprazole, as well as risperidone, had rapid and persistent efficacy for psychotic symptoms from the first week of therapy. There may be poor efficacy for aripiprazole compared with risperidone for overall improvement, but there were no significant differences in this study. Aripiprazole showed good tolerability with less weight gain and hyperprolactinemia compared with risperidone. The overall efficacy and safety of aripiprazole in Chinese Han schizophrenia subjects were similar to that reported in Western populations.
Full-text · Article · Jun 2014 · Schizophrenia Research
[Show abstract][Hide abstract] ABSTRACT: Intramuscular (IM) antipsychotics are preferred for efficient control of agitation symptoms. Previous studies have demonstrated that IM ziprasidone is efficacious and safe for treatment of agitation in schizophrenia. However, clinicians now recognize that racial differences may contribute to altered therapeutic response and tolerability. This study compared the efficacy and tolerability of IM ziprasidone versus IM haloperidol for the management of agitation in Chinese subjects with schizophrenia. Subjects with acute schizophrenia were randomized to either ziprasidone (n = 189, 10 to 20 mg as required up to a maximum of 40 mg/d) or haloperidol (n = 187, 5 mg every 4 to 8 hours to a maximum of 20 mg/d) for 3 days. Psychiatric assessments and adverse events were assessed at baseline, 2, 4, 24, 48, and 72 hours. In the ziprasidone group, 2.1% of subjects discontinued versus 3.7% in the haloperidol group. The least squares mean change (SE) from baseline to 72 hours in Brief Psychiatry Rating Scale total score was -17.32 (0.7) for ziprasidone (n = 167) and -18.44 (0.7) for haloperidol (n = 152), with a 95% confidence interval treatment difference of -0.7 to 2.9. Fewer subjects experienced adverse events after ziprasidone (n = 54, 28.6%) than haloperidol (n = 116, 62.0%), with a notably higher incidence of extrapyramidal symptoms in the haloperidol group (n = 69, 36.9%) compared to the ziprasidone group (n = 4, 2.1%). For controlling agitation in schizophrenia in this Chinese study, ziprasidone had a favorable tolerability profile and comparable efficacy and safety compared to haloperidol.
No preview · Article · Apr 2013 · Journal of clinical psychopharmacology
[Show abstract][Hide abstract] ABSTRACT: The aim of the study was to evaluate the efficacy and safety of ziprasidone versus risperidone in Chinese subjects with acute exacerbation of schizophrenia.
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.
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.
In Chinese subjects, ziprasidone was as effective as risperidone, with less weight gain and less prolactin elevation.
Full-text · Article · Mar 2011 · Neuropsychiatric Disease and Treatment
[Show abstract][Hide abstract] ABSTRACT: The relative effectiveness of the atypical antipsychotic drugs and conventional agents in patients with early-stage schizophrenia has not been comprehensively determined.
The aim of our study was to evaluate the efficacy and safety of seven antipsychotic drugs for the maintenance treatment in patients with early-stage schizophrenia.
In a 12-month open-label, prospective observational, multicenter study, 1,133 subjects with schizophrenia or schizophreniform disorder within 5 years of onset were monotherapy with chlorpromazine, sulpiride, clozapine, risperidone, olanzapine, quetiapine, or aripiprazole. The primary measure was the rate of treatment discontinuation for any reason. Secondary outcomes included measures for clinical and functional outcomes and tolerability.
The percentage of patients discontinued treatment within 12 months was 41.4% for chlorpromazine, 39.5% for sulpiride, 36.7% for clozapine, 40.2% for risperidone, 39.6% for olanzapine, 46.9% for quetiapine, and 40.2% for aripiprazole, a nonsignificant difference (p = 0.717); there were no significant differences among these seven treatments on discontinuation due to relapse, intolerability, patient decision, or nonadherence (all p values ≥ 0.260). Extrapyramidal symptoms were more prominent in chlorpromazine and sulpiride treatment groups. Anticholinergic side effects were most common with clozapine and chlorpromazine. Weight gain was most common with olanzapine and clozapine.
The efficacy of seven antipsychotic medications for the maintenance treatment appeared similar in early-stage schizophrenia. With regard to the high dropout rate and side effects, special programs are needed to keep efficacy and safety of antipsychotics maintenance treatment for schizophrenia with early stage.
Full-text · Article · Mar 2011 · Psychopharmacology
[Show abstract][Hide abstract] ABSTRACT: 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.
To evaluate the effectiveness of antipsychotic medication alone vs combined with psychosocial intervention on outcomes of early-stage schizophrenia.
Randomized controlled trial.
Ten clinical sites in China.
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.
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.
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).
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.
clinicaltrials.gov Identifier: NCT00654576.
Full-text · Article · Sep 2010 · Archives of general psychiatry
[Show abstract][Hide abstract] ABSTRACT: To compare the effect of 7 antipsychotic drugs on the life quality of schizophrenia patients including chlorpromazine, sulpiride, clozapine, risperidone, olanzapine, quetiapine, and aripiprazole.
A total of 1,227 stable schizophrenic patients within 5 years onset who took 1 of the 7 study medications as maintenance treatment were followed up for 1 year at 10 China sites. Patients were evaluated by the short form-36 health survey (SF-36) at the baseline and at the end of 1 year.
The life quality was improved obviously at the end of the follow-up. There was significant difference in body pain, vitality, and mental health (P<0.05) among these antipsychotic drugs.
All 7 antipsychotic drugs can improve the life quality of schizophrenia patients. Atypical antipsychotic drugs, especially olazapine and quetiapine, are superior to typical antipsychotic drugs in improving life quality.
No preview · Article · Sep 2009 · Zhong nan da xue xue bao. Yi xue ban = Journal of Central South University. Medical sciences