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The purpose of this study is to compare the efficacy and side effects of 6 commonly used antipsychotic drugs in the treatment of schizophrenia in a Chinese population.
The relative effectiveness of second-generation (atypical) antipsychotic drugs as compared with that of older agents has been incompletely addressed, though newer agents are currently used far more commonly. The investigators compared a first-generation antipsychotic, perphenazine or haloperidol, with several newer drugs in a double-blind study.
METHODS: A total of 550 patients with schizophrenia were recruited at 4 Chinese sites and randomly assigned to receive perphenazine (16 to 64 mg per day) or haloperidol(6 t0 20mg per day), olanzapine (5 to 20 mg per day), quetiapine (400 to 750 mg per day), aripiprazole (10 to 30 mg per day) or risperidone (2 to 6.0 mg per day) for up to 8 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Typical antipsychotic | Experimental | Haloperidol (6~20mg/day) and perphenazine (16~64mg/day) for 8 weeks. |
|
| Risperidone | Active Comparator | Risperidone, 2~6mg/day, twice day, 8 weeks |
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| Olanzapine | Active Comparator | 5~20mg/day |
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| Quetiapine | Active Comparator | 400~750mg/day |
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| Aripiprazole | Active Comparator | Aripiprazole, 10~30mg/day, twice per day, 8 weeks |
|
| Ziprasidone | Active Comparator | Ziprasidone, 80~160mg/day, twice per day, 8 weeks |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Typical antipsychotic | Drug | Haloperidol (6~20mg/day) and perphenazine (16~64mg/day), twice per day, 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Positive and Negative Syndrome Scale (PANSS) | Baseline, 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Global Impression (CGI) | The Clinical Global Impression rating scales are commonly used measures of symptom severity, treatment response and the efficacy of treatments in treatment studies of patients with mental disorders | Baseline, 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Udvalg for Kliniske Undersogelser (UKU) Side Effect Rating Scale | The UKU Side Effect Rating Scale is a comprehensive, clinician-rated scale, designed to assess the side effects in patients treated with psychotropic medications. | Baseline, 8 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhi-Ren Wang, MD, PhD | Beijing HuiLongGuan Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing HuiLongGuan Hospital | Beijing | 100096 | China |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D006220 | Haloperidol |
| D010546 | Perphenazine |
| D018967 | Risperidone |
| D000077152 | Olanzapine |
| D000069348 | Quetiapine Fumarate |
| C092292 | ziprasidone |
| ID | Term |
|---|---|
| D002090 | Butyrophenones |
| D007659 | Ketones |
| D009930 | Organic Chemicals |
| D010640 | Phenothiazines |
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| Risperidone | Drug | 2~6mg/day, twice per day, 8 weeks |
|
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| Olanzapine | Drug | Olanzapine, 400~750mg/day, twice per day, 8 weeks |
|
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| Quetiapine | Drug | Quetiapine, 400~750mg/day, twice per day, 8 weeks |
|
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| Aripiprazole | Device | Aripiprazole, 10~30mg/day, twice per day, 8 weeks |
|
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| Ziprasidone | Drug | Ziprasidone 80~160mg/day, twice per day, 8 weeks |
|
|
| D013457 |
| Sulfur Compounds |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D003987 | Dibenzothiazepines |
| D013841 | Thiazepines |
| D013846 | Thiepins |