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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00471588 |
Purpose
3 groups of subjects (healthy controls, OCD subjects and stimulant-dependent subjects) will receive pramipexole (1.5 mg, single dose), amisulpride (400 mg, single dose) or placebo in a cross-over, double-blind, placebo-controlled design.
Effects of compulsive behaviour will be assessed using fMRI and cognitive testing.
Assess biomarkers including cardiovascular responses and plasma levels. All groups studied on 3 separate occasions following screening, with at least a week intervening between consecutive assessments. The procedures to be adopted for study assessment will be identical on each occasion.
| Condition | Intervention | Phase |
|---|---|---|
|
Obsessive-Compulsive Disorder |
Drug: Pramipexole, Amisulpride |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Dopamine D2/D3 Receptor Agonist and Antagonist Drug Effects on Fronto-striatal Systems Related to Compulsive Behaviour in Healthy Volunteers and Patients With Addictive and Compulsive Disorders |
| Enrollment: | 52 |
| Study Start Date: | August 2006 |
| Study Completion Date: | December 2007 |
| Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Participants who have any laboratory abnormality that in the investigator's judgement is considered to be clinically significant and could potentially affect subject safety or study outcome.
Contacts and Locations
More Information
| Responsible Party: | Study Director, GSK |
| ClinicalTrials.gov Identifier: | NCT00471588 History of Changes |
| Other Study ID Numbers: | TMT106512 |
| Study First Received: | May 8, 2007 |
| Last Updated: | October 13, 2010 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
|
Dopamine MRI OCD stimulant users |
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Obsessive-Compulsive Disorder Compulsive Behavior Anxiety Disorders Mental Disorders Impulsive Behavior Dopamine Dopamine Agents Pramipexol Sultopride Cardiotonic Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Sympathomimetics Autonomic Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Protective Agents Antioxidants Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Dopamine Agonists Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Dopamine Antagonists |