Schizophrenia Relapse
Conditions
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.
Interventions
DRUGreduction of risperidone, haloperidol, olanzapine, quetiapine, aripiprazole, paliperidone, levomepromazine, perphenazine
Sponsors
Juntendo University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Reduction Group Group of patients with schizophrenia undergoing high-dose therapy (\>1000-mg chlorpromazine eq./day) We attempted to reduce the dose of antipsychotics to ≤1000-mg chlorpromazine eq./day. | 130 |
| Total | 130 |
Baseline characteristics
| Characteristic | Reduction Group |
|---|---|
| Age, Continuous | 51.5 years STANDARD_DEVIATION 11.1 |
| Region of Enrollment Japan | 130 participants |
| Sex: Female, Male Female | 50 Participants |
| Sex: Female, Male Male | 80 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 51 / 130 |
| serious Total, serious adverse events | 0 / 130 |
Outcome results
Primary
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.
Time frame: One year after the baseline cognitive function test or three months after the end of dose reduction, whichever came first.
Population: patients with schizophrenia taking more than 1000 mg / day of antipsychotics, reduce their dose to less than 1000 mg
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dose Reduction | Number of Participants With Relapse | 130 Participants |