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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00471588 |
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 |
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Obsessive-Compulsive Disorder |
Drug: Pramipexole, Amisulpride |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Crossover Assignment, Pharmacokinetics Study |
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) |
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.
United Kingdom, Cambridgeshire | |
GSK Investigational Site | |
Cambridge, Cambridgeshire, United Kingdom, CB2 2GG |
Study Director: | GSK Clinical Trials, Prof. | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | TMT106512 |
Study First Received: | May 8, 2007 |
Last Updated: | October 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00471588 |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Dopamine MRI OCD stimulant users |
Compulsive Behavior Dopamine Anxiety Disorders Mental Disorders Sultopride |
Healthy Impulsive Behavior Pramipexol Obsessive-Compulsive Disorder |
Neurotransmitter Agents Tranquilizing Agents Antioxidants Disease Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Cardiotonic Agents Sympathomimetics Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Antiparkinson Agents |
Dopamine Antagonists Cardiovascular Agents Antipsychotic Agents Dopamine Agonists Protective Agents Pharmacologic Actions Pathologic Processes Autonomic Agents Therapeutic Uses Dopamine Agents Peripheral Nervous System Agents Central Nervous System Agents |