Therapeutic Effect of Quetiapine on Methamphetamine-Induced Psychosis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Therapeutic Effect Between Quetiapine and Haloperidol on the Treatment of Methamphetamine - Induced Psychosis

Conditions
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Methamphetamine-induced Psychosis

Intervention / Treatment
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* Drug: Diazepam
* Dietary Supplement: Vitamin B1-6-12
* Drug: Stugeron


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Having a psychotic episode with current use of methamphetamine Positive urine toxicology test for methamphetamine on the first day of hospitalization Exclusion Criteria: Using other illegal substances Having a history of primary psychotic disorders or using antipsychotic agents Having a chronic medical disease, e.g. essential hypertension, diabetes, epilepsy, stroke

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Quetiapine<br>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. | Drug: Diazepam<br>* 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.<br>Dietary Supplement: Vitamin B1-6-12<br>* 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.<br>Drug: Stugeron<br>* 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.<br>|
| Active Comparator: Haloperidol<br>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. | Drug: Diazepam<br>* 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.<br>Dietary Supplement: Vitamin B1-6-12<br>* 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.<br>Drug: Stugeron<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antipsychotic Adverse Event Form |  | Every day for three weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Quetiapine, Haloperidol, Methamphetamine, Psychosis