Schizophrenia
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGTypical antipsychotic
Haloperidol (6\ 20mg/day) and perphenazine (16\ 64mg/day), twice per day, 8 weeks
DRUGRisperidone
2\ 6mg/day, twice per day, 8 weeks
DRUGOlanzapine
Olanzapine, 400\ 750mg/day, twice per day, 8 weeks
DRUGQuetiapine
Quetiapine, 400～750mg/day, twice per day, 8 weeks
DEVICEAripiprazole
Aripiprazole, 10～30mg/day, twice per day, 8 weeks
DRUGZiprasidone
Ziprasidone 80\ 160mg/day, twice per day, 8 weeks
Sponsors
Beijing HuiLongGuan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Patients' diagnoses is based on the results of the Structured Clinical Interview for DSM (SCID) using the criteria of the fourth edition of the Diagnostic and Statistical Manual (DSM-IV), physical exams and routine chemistry, and hematology laboratory tests. Attending-level psychiatrists will use a Chinese translation of the SCID to interview patients and their family members, who are given freedom to ask additional questions if respondents do not understand the standard probes. * Patients must meet the following criteria: (1) diagnosis of schizophrenia; (2) duration of illness more than 2 years; (3) between 25 and 60 years of age; and (5) have NOT received antipsychotic medication for at least 1 month;(6) acute exacerbations of chronic inpatients. * A complete medical history, electroencephalograms and electrocardiogram are obtained, and a physical examination and laboratory tests are performed at study entrance. None of the study participants have abnormal findings on these tests.
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Positive and Negative Syndrome Scale (PANSS) | Baseline, 8 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Global Impression (CGI) | Baseline, 8 weeks | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Udvalg for Kliniske Undersogelser (UKU) Side Effect Rating Scale | Baseline, 8 weeks | The UKU Side Effect Rating Scale is a comprehensive, clinician-rated scale, designed to assess the side effects in patients treated with psychotropic medications. |
Countries
China
Outcome results
None listed