Therapeutic Effect of Quetiapine on Methamphetamine-Induced Psychosis

Phase 4

Completed

• Conditions: Methamphetamine-induced Psychosis
• Interventions: Drug: Diazepam; Dietary Supplement: Vitamin B1-6-12; Drug: Stugeron

• Registration Number: NCT01939093
• Lead Sponsor: Chulalongkorn University

Brief Summary

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

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.

Study Timeline

• Study Start: 2010-03
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2013-09
• Study First Submitted: 2013-09-02
• Study First Submitted QC: 2013-09-05
• Last Update Submitted: 2013-09-05
• Study First Posted: 2013-09-11
• Last Update Posted: 2013-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Quetiapine	Vitamin B1-6-12	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.
Quetiapine	Stugeron	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	Vitamin B1-6-12	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.
Haloperidol	Stugeron	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.
Quetiapine	Diazepam	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	Diazepam	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.

Primary Outcome Measures

Name	Time	Method
Positive and Negative Syndrome Scale	Every two days in Week 2 and 3.

Secondary Outcome Measures

Name	Time	Method
Antipsychotic Adverse Event Form	Every day for three weeks.

Trial Locations

Locations (1)

Thanyarak Institute on Drug Abuse; 🇹🇭 Pathumthani, Thailand