Back to resultsCorrelation Between Cognitive Function and Relapse of Schizophrenia Regarding Dose Reduction
Primary Purpose
Schizophrenia Relapse
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
reduction of risperidone, haloperidol, olanzapine, quetiapine, aripiprazole, paliperidone, levomepromazine, perphenazine
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia Relapse
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
reduction group
Arm Description
dose reduction of antipsychotics at a rate not exceeding 50mg chlorpromazine equivalent/week
Outcomes
Primary Outcome Measures
Number of Participants With Relapse
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03019887
Brief Title
Correlation Between Cognitive Function and Relapse of Schizophrenia Regarding Dose Reduction
Official Title
Correlation Between Cognitive Function and Relapse of Schizophrenia Regarding Dose Reduction in Patients Undergoing High-dose Antipsychotic Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Juntendo University
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia Relapse
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
139 (Actual)
8. Arms, Groups, and Interventions
Arm Title
reduction group
Arm Type
Experimental
Arm Description
dose reduction of antipsychotics at a rate not exceeding 50mg chlorpromazine equivalent/week
Intervention Type
Drug
Intervention Name(s)
reduction of risperidone, haloperidol, olanzapine, quetiapine, aripiprazole, paliperidone, levomepromazine, perphenazine
Primary Outcome Measure Information:
Title
Number of Participants With Relapse
Description
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.
Time Frame
One year after the baseline cognitive function test or three months after the end of dose reduction, whichever came first.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Takahashi Tadashi
Organizational Affiliation
Okada hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mikiro Saito
Organizational Affiliation
Okada hospital
Official's Role
Study Chair
12. IPD Sharing Statement
Learn more about this trial
Correlation Between Cognitive Function and Relapse of Schizophrenia Regarding Dose Reduction
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