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Standard Comprehensive Intervention to Treat First-episode Schizophrenia

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01057849
Enrollment
600
Registered
2010-01-27
Start date
2008-09-30
Completion date
Unknown
Last updated
2010-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

schizophrenia, first episode, atypical antipsychotics, psychosocial intervention, outcome, effectiveness

Brief summary

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.

Interventions

DRUGrisperidone

3-6 mg per day

DRUGolanzapine

5-20 mg per day

DRUGAripiprazole

10-30 mg per day

Sponsors

Ministry of Science and Technology of the People´s Republic of China
CollaboratorOTHER_GOV
Peking University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
16 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
the time the patients remain stable1 year

Secondary

MeasureTime frame
Scoring of PANSS and PSP1 year

Countries

China

Contacts

Primary ContactYanbo Yuan, M.D.
yuanyb@gmail.com+8613910821507

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026