Standard Comprehensive Intervention to Treat First-episode Schizophrenia

Study Overview
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Brief Summary
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Schizophrenia is not a curable but a treatable disease by antipsychotics. Kinds of atypical antipsychotics are widely used since 1990s' in China. Although their efficacy for acute phase are all better than typicals, individulized regimen of them for first-episode schizophrenia and their effectiveness in real naturalistic clinical settings still remain unclear. And those patients also need more comprehensive intervention such as psychosocial programs to improve their function. This protocol is to conduct a study in several sites of China to investigate the effectiveness of comprehensive intervention combining sequenced atypical antipsychotic therapy and intensive psychosocial intervention for first-episode schizophrenic patients. In addition, this protocol also aims at collecting such information as molecular genetics, neurochemical test, neucognitive performance and neuroimaging for outcome analysis.

Official Title
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Sequenced Atypical Antipsychotics Therapy With Intensive or Basic Psychosocial Intervention for First-episode Schizophrenia: An Effectiveness Study

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: risperidone
* Drug: olanzapine
* Drug: Aripiprazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: schizophrenic patients diagnosed with DSM-IV criteria by SCID-I. age between 16-45 years old with disease course less than 3 years and during their first episode without receiving systematic antipsychotic treatment less than 1 month Exclusion Criteria: organic disease or unstable physical diseases. brain trauma with loss of consciousness more than 1 hour current substance misuse (in 3 months) or any substance dependence. pregnant women. patients with severe suicidal imaginations or behavior. mental retardation contradict to the study drugs

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Risperidone, Intensive<br>risperidone and intensive psychosocial intervention | Drug: risperidone<br>* 3-6 mg per day<br>|
| Active Comparator: risperidone, basic<br>risperidone and basic psychosocial support | Drug: risperidone<br>* 3-6 mg per day<br>|
| Experimental: olanzapine, intensive<br>olanzapine and intensive psychosocial intervention | Drug: olanzapine<br>* 5-20 mg per day<br>|
| Active Comparator: olanzapine, basic<br>olanzapine and basic psychosocial support | Drug: olanzapine<br>* 5-20 mg per day<br>|
| Experimental: aripiprazole, intensive<br>aripiprazole and intensive psychosocial intervention | Drug: Aripiprazole<br>* 10-30 mg per day<br>|
| Active Comparator: aripiprazole, basiv<br>aripiprazole and basic psychosocial support | Drug: Aripiprazole<br>* 10-30 mg per day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the time the patients remain stable |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scoring of PANSS and PSP |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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schizophrenia, first episode, atypical antipsychotics, psychosocial intervention, outcome, effectiveness