Back to resultsTherapeutic Effect of Quetiapine on Methamphetamine-Induced Psychosis (MAP)
Primary Purpose
Methamphetamine-induced Psychosis
Status
Completed
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
Diazepam
Vitamin B1-6-12
Stugeron
Sponsored by
About this trial
This is an interventional treatment trial for Methamphetamine-induced Psychosis focused on measuring Quetiapine, Haloperidol, Methamphetamine, Psychosis
Eligibility 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
Sites / Locations
- Thanyarak Institute on Drug Abuse
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Quetiapine
Haloperidol
Arm Description
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 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.
Outcomes
Primary Outcome Measures
Positive and Negative Syndrome Scale
Positive and Negative Syndrome Scale
Secondary Outcome Measures
Antipsychotic Adverse Event Form
Full Information
NCT ID
NCT01939093
First Posted
September 2, 2013
Last Updated
September 5, 2013
Sponsor
Chulalongkorn University
Collaborators
Thanyarak Institute, National Research Council of Thailand
1. Study Identification
Unique Protocol Identification Number
NCT01939093
Brief Title
Therapeutic Effect of Quetiapine on Methamphetamine-Induced Psychosis
Acronym
MAP
Official Title
Therapeutic Effect Between Quetiapine and Haloperidol on the Treatment of Methamphetamine - Induced Psychosis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chulalongkorn University
Collaborators
Thanyarak Institute, National Research Council of Thailand
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Methamphetamine-induced Psychosis
Keywords
Quetiapine, Haloperidol, Methamphetamine, Psychosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Quetiapine
Arm Type
Experimental
Arm Description
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.
Arm Title
Haloperidol
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Diazepam
Intervention Description
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
Dietary Supplement
Intervention Name(s)
Vitamin B1-6-12
Intervention Description
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
Drug
Intervention Name(s)
Stugeron
Intervention Description
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 Measure Information:
Title
Positive and Negative Syndrome Scale
Time Frame
Every day in Week 1.
Title
Positive and Negative Syndrome Scale
Time Frame
Every two days in Week 2 and 3.
Secondary Outcome Measure Information:
Title
Antipsychotic Adverse Event Form
Time Frame
Every day for three weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Viroj Verachai, M.D.
Organizational Affiliation
Thanyarak Institute on Drug Abuse
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thanyarak Institute on Drug Abuse
City
Pathumthani
Country
Thailand
12. IPD Sharing Statement
Learn more about this trial
Therapeutic Effect of Quetiapine on Methamphetamine-Induced Psychosis
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