Therapeutic Effect of Quetiapine on Methamphetamine-Induced Psychosis

Methamphetamine-induced Psychosis Clinical Trial

— MAP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01939093
• Other study ID #: NRCT-53069
• Status: Completed
• Phase: Phase 4
• First received: September 2, 2013
• Last updated: September 5, 2013
• Start date: March 2010
• Est. completion date: September 2011

Study information

• Verified date: September 2013
• Source: Chulalongkorn University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: National Research Council of Thailand
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mental Disorders
• Methamphetamine-induced Psychosis
• Psychotic Disorders

Intervention

Drug:
• Diazepam
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.

Dietary Supplement:
• Vitamin B1-6-12
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.

Drug:
• Stugeron
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.

Locations

Country	Name	City	State
Thailand	Thanyarak Institute on Drug Abuse	Pathumthani

Sponsors (3)

Lead Sponsor	Collaborator
Chulalongkorn University	National Research Council of Thailand, Thanyarak Institute

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive and Negative Syndrome Scale		Every day in Week 1.	No
Primary	Positive and Negative Syndrome Scale		Every two days in Week 2 and 3.	No
Secondary	Antipsychotic Adverse Event Form		Every day for three weeks.	Yes