- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01939093
Therapeutic Effect of Quetiapine on Methamphetamine-Induced Psychosis (MAP)
September 5, 2013 updated by: Rasmon Kalayasiri, Chulalongkorn University
Therapeutic Effect Between Quetiapine and Haloperidol on the Treatment of 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Pathumthani, Thailand
- Thanyarak Institute on Drug Abuse
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / 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.
|
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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Positive and Negative Syndrome Scale
Time Frame: Every day in Week 1.
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Every day in Week 1.
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Positive and Negative Syndrome Scale
Time Frame: Every two days in Week 2 and 3.
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Every two days in Week 2 and 3.
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Antipsychotic Adverse Event Form
Time Frame: Every day for three weeks.
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Every day for three weeks.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Viroj Verachai, M.D., Thanyarak Institute on Drug Abuse
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2010
Primary Completion (Actual)
September 1, 2011
Study Completion (Actual)
September 1, 2011
Study Registration Dates
First Submitted
September 2, 2013
First Submitted That Met QC Criteria
September 5, 2013
First Posted (Estimate)
September 11, 2013
Study Record Updates
Last Update Posted (Estimate)
September 11, 2013
Last Update Submitted That Met QC Criteria
September 5, 2013
Last Verified
September 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Schizophrenia Spectrum and Other Psychotic Disorders
- Schizophrenia
- Psychotic Disorders
- Mental Disorders
- Shared Paranoid Disorder
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Antiemetics
- Gastrointestinal Agents
- Micronutrients
- Tranquilizing Agents
- Psychotropic Drugs
- Membrane Transport Modulators
- Hypnotics and Sedatives
- Adjuvants, Anesthesia
- Anti-Anxiety Agents
- GABA Modulators
- GABA Agents
- Anticonvulsants
- Vitamins
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Neuromuscular Agents
- Vitamin B Complex
- Histamine H1 Antagonists
- Histamine Antagonists
- Histamine Agents
- Muscle Relaxants, Central
- Diazepam
- Thiamine
- Cinnarizine
Other Study ID Numbers
- NRCT-53069
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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