Sequential Multiple-Assignment Randomized Trials to Compare Antipsychotic Treatments(SMART-CAT)

Plain-language summary

This study compares different antipsychotic medications such as Olanzapine, Risperidone, Amisulpride, Aripiprazole, and Clozapine within a stepwise treatment plan in patients with first-episode schizophrenia or a related psychotic disorder. It enrolled patients aged 16 to 45 experiencing a first episode with moderate or more severe psychotic symptoms. The study was conducted in Phase 3 and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 3

Status

Completed

Sponsor

Shanghai Mental Health Center

Intervention

Phase 1: Olanzapine, Phase 1: Risperidone, Phase 1: Amisulpride, Phase 1: Aripiprazole, Phase 1: Perphenazine, Phase 2: Olanzapine, Phase 2: Amisulpride, Phase 2: Clozapine, Phase 3A: Clozapine extended treatment or Combined clozapine-MECT therapy, Phase 3B: Clozapine or another SGAs

Start date

2/12/2019

Estimated completion

9/27/2023

Countries

China

Related genes

Locations

• Beijing, China
• Wuhan, China
• Nanjing, China
• Dalian, China
• Shanghai, China
• Kunming, China
• Hangzhou, China

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion criteria:

1. Patients must meet the DSM-5 diagnostic criteria for schizophrenia , schizophreniform disorder or schizoaffective disorder, based upon the structured clinical interview by research psychiatrist using Mini International Neuropsychiatric Interview 7.0 (M.I.N.I. 7.0), review of their clinical records, and input from available informants.
2. Inpatients or outpatients.
3. 16-45 years of age.
4. First episode, and the course no more than 3 years.
5. Drug-naïve, or any antipsychotic medication had been used no more than 2 weeks, and the cumulative antipsychotic drug exposure time no more than 6 weeks in lifetime.
6. The severity of psychotic symptoms is moderate or above, and the specific criteria including: have a score ≥4 on at least one item of Positive and Negative Syndrome Scale (PANSS) (delusions, conceptual disorganization, hallucinatory behavior, grandiosity, or suspiciousness/persecution), and PANSS total score \>70.
7. Patients must demonstrate adequate decisional capacity to make a choice about participating in this research study and must provide informed consent to participate.

Exclusion criteria:

1. Patients were excluded if more than 3 years had passed since the onset of psychosis;
2. They met any of the contraindications for any of the study drugs;
3. Mental symptoms were caused by organic disease, severe physical illness, psychoactive substance dependence, mental retardation;
4. They were pregnancy or breast-feeding; they were extreme agitation, stupor or negative suicide.