Correlation Between Cognitive Function and Relapse of Schizophrenia Regarding Dose Reduction in Patients Undergoing High-dose Antipsychotic Therapy
| Registry | NCT03019887 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; na, single group, masking: none, treatment |
| Enrollment | 139 (Actual) |
| Sponsor | Juntendo University (Other) |
| Conditions | Schizophrenia Relapse |
| Interventions | reduction of risperidone, haloperidol, olanzapine, quetiapine, aripiprazole, paliperidone, levomepromazine, perphenazine (Drug) |
| Dates | start 2011-04-01, primary completion 2017-01-01, completion 2017-01-01, first posted 2017-01-13, last updated 2021-09-09 |
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All trials for Schizophrenia Relapse All trials of reduction of risperidone, haloperidol, olanzapine, quetiapine, aripiprazole, paliperidone, levomepromazine, perphenazine
To reduce antipsychotics to under 1000mg in patients with schizophrenia taking more than 1000mg/day and to evaluate relationship between relapse and cognitive function.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| reduction group | Experimental | Drug: reduction of risperidone, haloperidol, olanzapine, quetiapine, aripiprazole, paliperidone, levomepromazine, perphenazine | dose reduction of antipsychotics at a rate not exceeding 50mg chlorpromazine equivalent/week |
Sex: All, ages: 20 Years to 70 Years
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
| Milestone | Dose Reduction |
|---|---|
| Started | 139 |
| Completed | 130 |
| Not completed | 9 |
| Arm | Deaths | Serious adverse events | Other adverse events |
|---|---|---|---|
| Dose Reduction | 0 | 0/130 (0.0%) | 51/130 (39.2%) |
| Term | Organ system | Dose Reduction |
|---|---|---|
| increase in the total PANSS score from baseline | Psychiatric disorders | 51/130 |
| increase in total DIEPSS score | Psychiatric disorders | 0/130 |
| violent behavior | Psychiatric disorders | 15/130 |