Correlation Between Cognitive Function and Relapse of Schizophrenia Regarding Dose Reduction

Not Applicable

Completed

• Conditions: Schizophrenia Relapse
• Interventions: Drug: reduction of risperidone, haloperidol, olanzapine, quetiapine, aripiprazole, paliperidone, levomepromazine, perphenazine

• Registration Number: NCT03019887
• Lead Sponsor: Juntendo University

Brief Summary

To reduce antipsychotics to under 1000mg in patients with schizophrenia taking more than 1000mg/day and to evaluate relationship between relapse and cognitive function.

Detailed Description

We attempted to reduce the dose of antipsychotics to ≤1000-mg chlorpromazine eq./day. The dose was gradually reduced at a rate of ≤50-mg chlorpromazine eq./week, and the reduction was discontinued if the subjects relapsed. The differences in baseline cognitive function were analyzed between the patients with no relapse and relapse groups.

Study Timeline

• Study Start: 2011-04
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Study First Submitted: 2017-01-11
• Study First Submitted QC: 2017-01-12
• Study First Posted: 2017-01-13
• Results First Submitted: 2017-01-19
• Status Verified: 2021-08
• Results First Submitted QC: 2021-08-11
• Last Update Submitted: 2021-08-11
• Results First Posted: 2021-09-09
• Last Update Posted: 2021-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 139

Inclusion Criteria

• inpatients with a diagnosis of schizophrenia, and
• those in the chronic phase receiving mean daily antipsychotic doses exceeding 1000-mg chlorpromazine eq./day.

Exclusion Criteria

• mental retardation,
• substance abuse or dependence,
• a history of major head trauma,
• serious medical or neurological disorders, or
• depot antipsychotic injections within the previous 3 months and electroconvulsive therapy within the previous 6 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
reduction group	reduction of risperidone, haloperidol, olanzapine, quetiapine, aripiprazole, paliperidone, levomepromazine, perphenazine	dose reduction of antipsychotics at a rate not exceeding 50mg chlorpromazine equivalent/week

Primary Outcome Measures

Name	Time	Method
Number of Participants With Relapse	One year after the baseline cognitive function test or three months after the end of dose reduction, whichever came first.	The definition of relapse is as follows 1.50% or greater increase in total DIEPSS score, 2. an increase in the total PANSS score of 25% or more from baseline, 3. deliberate self-injury, 4. emergence of clinically significant suicidal ideation, 5. violent behavior resulting in clinically significant injury to another person or property damage.