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Completed

NCT Number: NCT01939093

Therapeutic Effect of Quetiapine on Methamphetamine-Induced Psychosis

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.

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Key information

Conditions

Methamphetamine-induced Psychosis Mental Disorders Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Thanyarak Institute on Drug Abuse

Pathum Thani, Changwat Pathum Thani, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Positive and Negative Syndrome Scale

    Time frame: Every day in Week 1.

  2. Positive and Negative Syndrome Scale

    Time frame: Every two days in Week 2 and 3.

Secondary outcomes

  1. Antipsychotic Adverse Event Form

    Time frame: Every day for three weeks.

Sponsors and collaborators

Lead sponsor

Chulalongkorn University

Other

Collaborators

  • National Research Council of Thailand
  • Thanyarak Institute

Registry information

Official study title

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

Acronym: MAP

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Sep 11, 2013
Registry last updated
Sep 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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