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Therapeutic Effect of Quetiapine on Methamphetamine-Induced Psychosis (MAP)

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ClinicalTrials.gov Identifier: NCT01939093
Recruitment Status : Completed
First Posted : September 11, 2013
Last Update Posted : September 11, 2013
Sponsor:
Collaborators:
Thanyarak Institute
National Research Council of Thailand
Information provided by (Responsible Party):
Rasmon Kalayasiri, 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.

Condition or disease Intervention/treatment Phase
Methamphetamine-induced Psychosis Drug: Diazepam Dietary Supplement: Vitamin B1-6-12 Drug: Stugeron Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Therapeutic Effect Between Quetiapine and Haloperidol on the Treatment of Methamphetamine - Induced Psychosis
Study Start Date : March 2010
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011


Arm Intervention/treatment
Experimental: 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.
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.

Active Comparator: 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.
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.




Primary Outcome Measures :
  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 Outcome Measures :
  1. Antipsychotic Adverse Event Form [ Time Frame: Every day for three weeks. ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01939093


Locations
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Thailand
Thanyarak Institute on Drug Abuse
Pathumthani, Thailand
Sponsors and Collaborators
Chulalongkorn University
Thanyarak Institute
National Research Council of Thailand
Investigators
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Principal Investigator: Viroj Verachai, M.D. Thanyarak Institute on Drug Abuse

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Responsible Party: Rasmon Kalayasiri, Assistant Professor, Chulalongkorn University
ClinicalTrials.gov Identifier: NCT01939093     History of Changes
Other Study ID Numbers: NRCT-53069
First Posted: September 11, 2013    Key Record Dates
Last Update Posted: September 11, 2013
Last Verified: September 2013

Keywords provided by Rasmon Kalayasiri, Chulalongkorn University:
Quetiapine
Haloperidol
Methamphetamine
Psychosis

Additional relevant MeSH terms:
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Psychotic Disorders
Mental Disorders
Shared Paranoid Disorder
Schizophrenia Spectrum and Other Psychotic Disorders
Schizophrenia
Vitamins
Thiamine
Vitamin B Complex
Cinnarizine
Diazepam
Haloperidol
Quetiapine Fumarate
Haloperidol decanoate
Methamphetamine
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents