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Therapeutic Effect of Quetiapine on Methamphetamine-Induced Psychosis

NCT ID: NCT01939093

Last Updated: 2013-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2011-09-30

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.

Conditions

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Methamphetamine-induced Psychosis

Keywords

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Quetiapine Haloperidol Methamphetamine Psychosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Quetiapine

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.

Group Type EXPERIMENTAL

Diazepam

Intervention Type 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.

Vitamin B1-6-12

Intervention Type 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

Intervention Type 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.

Haloperidol

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.

Group Type ACTIVE_COMPARATOR

Diazepam

Intervention Type 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.

Vitamin B1-6-12

Intervention Type 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

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type DIETARY_SUPPLEMENT

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.

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Thanyarak Institute

UNKNOWN

Sponsor Role collaborator

National Research Council of Thailand

OTHER_GOV

Sponsor Role collaborator

Chulalongkorn University

OTHER

Sponsor Role lead

Responsible Party

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Rasmon Kalayasiri

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Viroj Verachai, M.D.

Role: PRINCIPAL_INVESTIGATOR

Thanyarak Institute on Drug Abuse

Locations

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Thanyarak Institute on Drug Abuse

Pathum Thani, Changwat Pathum Thani, Thailand

Site Status

Countries

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Thailand

Other Identifiers

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NRCT-53069

Identifier Type: -

Identifier Source: org_study_id