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| Name | Class |
|---|---|
| Thanyarak Institute | UNKNOWN |
| National Research Council of Thailand | OTHER_GOV |
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The aims of this study are to compare the antipsychotic and adverse events of quetiapine, an atypical antipsychotic drug, to haloperidol, a standard treatment for primary psychotic disorder, in individuals with MAP.
Eighty individuals with MAP will be randomly assigned into two treatment groups, i.e. treatment with quetiapine and haloperidol. The quetiapine group will receive quetiapine at least 100 mg per day and the haloperidol group will receive haloperidol at least 2 mg per day orally once a day for four weeks. The doses will be increased every 5 days until no psychotic symptom is observed from the Positive and Negative Syndrome Scale. Common antipsychotic adverse events will be checked and documented daily.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Quetiapine | Experimental | Quetiapine 100 mg per day is taken orally once a day for four weeks. The dose is increased every 5 days until no psychotic symptom is observed. |
|
| Haloperidol | Active Comparator | Haloperidol 2 mg per day is taken orally once a day for four weeks. The dose is increased every 5 days until no psychotic symptom is observed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diazepam | Drug | If subjects had aggressive or violent symptoms and immediate symptom control was needed, 10 mg of diazepam (intravenous injection) every 4 hours is allowed for symptom control. |
| Measure | Description | Time Frame |
|---|---|---|
| Positive and Negative Syndrome Scale | Every day in Week 1. | |
| Positive and Negative Syndrome Scale | Every two days in Week 2 and 3. |
| Measure | Description | Time Frame |
|---|---|---|
| Antipsychotic Adverse Event Form | Every day for three weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Viroj Verachai, M.D. | Thanyarak Institute on Drug Abuse | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thanyarak Institute on Drug Abuse | Pathum Thani | Changwat Pathum Thani | Thailand |
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| ID | Term |
|---|---|
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D003975 | Diazepam |
| D002936 | Cinnarizine |
| ID | Term |
|---|---|
| D001570 | Benzodiazepinones |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| Vitamin B1-6-12 | Dietary Supplement | All subjects will be given the Institute's medication regimen, including vitamin B1-6-12 1 tablet three times a day after meals during the whole study period. |
|
| Stugeron | Drug | All subjects will be given the Institute's medication regimen, including stugeron 1 tablet three times a day after meals during the whole study period. |
|
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |