Standard Comprehensive Intervention to Treat First-episode Schizophrenia

Peking University

Status: Unknown

Conditions: Schizophrenia

Treatments: Drug: Aripiprazole; Drug: olanzapine; Drug: risperidone

Study type: Interventional

Funder types: Other

Identifiers

NCT01057849

2007BAI17B04

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: All

Ages: 16 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

600 participants in 6 patient groups

Risperidone, Intensive

Experimental group

Description:

risperidone and intensive psychosocial intervention

Treatment:

Drug: risperidone

risperidone, basic

Active Comparator group

Description:

risperidone and basic psychosocial support

Treatment:

Drug: risperidone

olanzapine, intensive

Experimental group

Description:

olanzapine and intensive psychosocial intervention

Treatment:

Drug: olanzapine

olanzapine, basic

Active Comparator group

Description:

olanzapine and basic psychosocial support

Treatment:

Drug: olanzapine

aripiprazole, intensive

Experimental group

Description:

aripiprazole and intensive psychosocial intervention

Treatment:

Drug: Aripiprazole

aripiprazole, basiv

Active Comparator group

Description:

aripiprazole and basic psychosocial support

Treatment:

Drug: Aripiprazole