Therapeutic Effect of Quetiapine on Methamphetamine-Induced Psychosis
MAP
Therapeutic Effect Between Quetiapine and Haloperidol on the Treatment of Methamphetamine - Induced Psychosis
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Mar 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 2, 2013
CompletedFirst Posted
Study publicly available on registry
September 11, 2013
CompletedSeptember 11, 2013
September 1, 2013
1.5 years
September 2, 2013
September 5, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Positive and Negative Syndrome Scale
Every day in Week 1.
Positive and Negative Syndrome Scale
Every two days in Week 2 and 3.
Secondary Outcomes (1)
Antipsychotic Adverse Event Form
Every day for three weeks.
Study Arms (2)
Quetiapine
EXPERIMENTALQuetiapine 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
ACTIVE COMPARATORHaloperidol 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.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- Having a psychotic episode with current use of methamphetamine
- Positive urine toxicology test for methamphetamine on the first day of hospitalization
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Chulalongkorn Universitylead
- Thanyarak Institutecollaborator
- National Research Council of Thailandcollaborator
Study Sites (1)
Thanyarak Institute on Drug Abuse
Pathum Thani, Changwat Pathum Thani, Thailand
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Viroj Verachai, M.D.
Thanyarak Institute on Drug Abuse
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
September 2, 2013
First Posted
September 11, 2013
Study Start
March 1, 2010
Primary Completion
September 1, 2011
Study Completion
September 1, 2011
Last Updated
September 11, 2013
Record last verified: 2013-09