Correlation Between Cognitive Function and Relapse of Schizophrenia Regarding Dose Reduction

August 11, 2021 updated by: Ryota Ataniya, Juntendo University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

139

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: reduction group
dose reduction of antipsychotics at a rate not exceeding 50mg chlorpromazine equivalent/week
Drug: reduction of risperidone, haloperidol, olanzapine, quetiapine, aripiprazole, paliperidone, levomepromazine, perphenazine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Relapse
Time Frame: 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.
One year after the baseline cognitive function test or three months after the end of dose reduction, whichever came first.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Juntendo University

Investigators

  • Study Chair: Takahashi Tadashi, Okada hospital
  • Study Chair: Mikiro Saito, Okada hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (ACTUAL)

January 1, 2017

Study Completion (ACTUAL)

January 1, 2017

Study Registration Dates

First Submitted

January 11, 2017

First Submitted That Met QC Criteria

January 12, 2017

First Posted (ESTIMATE)

January 13, 2017

Study Record Updates

Last Update Posted (ACTUAL)

September 9, 2021

Last Update Submitted That Met QC Criteria

August 11, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 673

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Schizophrenia Relapse

Clinical Trials on reduction of risperidone, haloperidol, olanzapine, quetiapine, aripiprazole, paliperidone, levomepromazine, perphenazine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sweden

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe