Sequenced Atypical Antipsychotics Therapy With Intensive or Basic Psychosocial Intervention for First-episode Schizophrenia: An Effectiveness Study
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 600
- Locations
- 6
- Primary Endpoint
- the time the patients remain stable
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 16 Years to 45 Years (Child, Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Risperidone, Intensive
risperidone and intensive psychosocial intervention
Intervention: risperidone (Drug)
risperidone, basic
risperidone and basic psychosocial support
Intervention: risperidone (Drug)
olanzapine, intensive
olanzapine and intensive psychosocial intervention
Intervention: olanzapine (Drug)
olanzapine, basic
olanzapine and basic psychosocial support
Intervention: olanzapine (Drug)
aripiprazole, intensive
aripiprazole and intensive psychosocial intervention
Intervention: Aripiprazole (Drug)
aripiprazole, basiv
aripiprazole and basic psychosocial support
Intervention: Aripiprazole (Drug)
Outcomes
Primary Outcomes
the time the patients remain stable
Time Frame: 1 year
Secondary Outcomes
- Scoring of PANSS and PSP(1 year)