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Correlation Between Cognitive Function and Relapse of Schizophrenia Regarding Dose Reduction

NCT03019887 — Not applicable, Completed, 139 participants, Juntendo University

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Correlation Between Cognitive Function and Relapse of Schizophrenia Regarding Dose Reduction in Patients Undergoing High-dose Antipsychotic Therapy

RegistryNCT03019887
StatusCompleted
PhaseNot applicable
Study typeInterventional; na, single group, masking: none, treatment
Enrollment139 (Actual)
SponsorJuntendo University (Other)
ConditionsSchizophrenia Relapse
Interventionsreduction of risperidone, haloperidol, olanzapine, quetiapine, aripiprazole, paliperidone, levomepromazine, perphenazine (Drug)
Datesstart 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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-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
reduction groupExperimentalDrug: reduction of risperidone, haloperidol, olanzapine, quetiapine, aripiprazole, paliperidone, levomepromazine, perphenazinedose reduction of antipsychotics at a rate not exceeding 50mg chlorpromazine equivalent/week
  • reduction of risperidone, haloperidol, olanzapine, quetiapine, aripiprazole, paliperidone, levomepromazine, perphenazine (Drug)

+Outcome measures

Primary outcomes

  • 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.

+Eligibility

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

+Posted results

Participant flow

MilestoneDose Reduction
Started139
Completed130
Not completed9

Outcome results

  • Number of Participants With Relapse (Primary), Count of participants, Participants: Dose Reduction 130

Adverse events

ArmDeathsSerious adverse eventsOther adverse events
Dose Reduction00/130 (0.0%)51/130 (39.2%)

Other adverse events by term

TermOrgan systemDose Reduction
increase in the total PANSS score from baselinePsychiatric disorders51/130
increase in total DIEPSS scorePsychiatric disorders0/130
violent behaviorPsychiatric disorders15/130

+Investigators

My Notes