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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| reduction group | Experimental | dose reduction of antipsychotics at a rate not exceeding 50mg chlorpromazine equivalent/week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| reduction of risperidone, haloperidol, olanzapine, quetiapine, aripiprazole, paliperidone, levomepromazine, perphenazine | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | One year after the baseline cognitive function test or three months after the end of dose reduction, whichever came first. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Takahashi Tadashi | Okada hospital | Study Chair |
| Mikiro Saito | Okada hospital | Study Chair |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dose Reduction | patients who reduced dose of antipsychotics |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | patients with schizophrenia taking more than 1000 mg / day of antipsychotics, reduce their dose to less than 1000 mg | Posted | Count of Participants | Participants | One year after the baseline cognitive function test or three months after the end of dose reduction, whichever came first. |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dose Reduction | patients who reduced dose of antipsychotics |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| increase in the total PANSS score from baseline | Psychiatric disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ryota Ataniya | Okada hospital | +81-4-7124-6151 | ryotaataniya@pbt.nir.jp |
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| ID | Term |
|---|---|
| D006220 | Haloperidol |
| D000077152 | Olanzapine |
| D000069348 | Quetiapine Fumarate |
| D000068180 | Aripiprazole |
| D000068882 | Paliperidone Palmitate |
| D008728 | Methotrimeprazine |
| D010546 | Perphenazine |
| ID | Term |
|---|---|
| D002090 | Butyrophenones |
| D007659 | Ketones |
| D009930 | Organic Chemicals |
| D001569 | Benzodiazepines |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 130 |
| 51 |
| 130 |
| increase in total DIEPSS score | Psychiatric disorders |
|
| violent behavior | Psychiatric disorders |
|
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| D001552 |
| Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003987 | Dibenzothiazepines |
| D013841 | Thiazepines |
| D013846 | Thiepins |
| D013457 | Sulfur Compounds |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D007555 | Isoxazoles |
| D001393 | Azoles |
| D011743 | Pyrimidines |
| D010640 | Phenothiazines |