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Trial: NCT01939093 [RDF]

Label NCT01939093
Slug nct01939093
Trialid NCT01939093
Lookup name NCT01939093
Provenance http://clinicaltrials.gov/show/NCT01939093?displayxml=true
Lastchanged date September 5, 2013
Firstreceived results date
Firstreceived date September 2, 2013
Id info nct id NCT01939093
Overall status Completed
Id info secondary id
Biospec retention
Required header link text Link to the current ClinicalTrials.gov record.
Enrollment 80
Number of arms 2
Is section 801 Yes
Is fda regulated Yes
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
Id info nct alias
Completion date September 2011
Verification date September 2013
Why stopped
Id info org study id NRCT-53069
Required header url http://clinicaltrials.gov/show/NCT01939093
Study design Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Source Chulalongkorn University
Primary completion date September 2011
Brief summary
Number of groups
Required header download date ClinicalTrials.gov processed this data on September 10, 2013
Phase Phase 4
Start date March 2010
Has expanded access No
Biospec descr
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.
Condition browse 01d83f579ac8f9f58ec8a7ffea1fb944
Intervention browse 39b715ab213899cf5eb987f85be57b0a
Responsible party 015b495dfd0be1a85fcb46d41f363abd
Overall contact None
Overall contact backup None
Sponsor group df9fb2681b0f3068674d870cacf6121c
Oversight info Thailand: National Research Council of Thailand (Oversight_info)
Eligibility 90abead56d0f12b3afca5584c77321ec
Keywords Haloperidol, Methamphetamine, Psychosis, quetiapine
Conditions Methamphetamine-induced Psychosis
Locations 3455b72eea26f8c8370024037e91a4c4
Links None
Results references None
Arm groups Quetiapine (Arm Group), Haloperidol (Arm Group)
Location countries Thailand
Interventions Vitamin B1-6-12 (Intervention), Diazepam (Intervention), Stugeron (Intervention)
Secondary outcomes a14f3c6ca87fb998eef732f0e0131e82
References None
Primary outcomes fcf692d37b07dde3776fb5160caaff95, ff286088348140b4ab5579b48d27147c
Removed countries None
Overall officials 15c039d97ded1c7489d1e4829327607a