Characterize The Modulatory Effects Of Dopamine D2/D3 Receptor Agonist And Antagonist Drugs On Compulsive Behaviors
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.
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
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|
- Investigate that drug addicts or OCD patients will show similar abnormalities of compulsive behaviour and functional activation of ventral fronto-striatal systems. MRI scans will occur on Wk 1, 2 and 3. Neuropsychological testing Wk 1, 2 and 3. [ Time Frame: on Wk 1, 2 and 3 ]
- Test the prediction that a dopamine D2/D3 agonist drug (pramipexole)by PK levels. PK sample taken on Week 1 only. [ Time Frame: on Week 1 only. ]
- Measure of brain functional activation at rest. [ Time Frame: up to week 3 ]
- Measure of behavioural performance [ Time Frame: up to week 3 ]
- Measure of peripheral blood for gene expression and proteomic changes. [ Time Frame: up to week 3 ]
- Genetic variation in selected genes [ Time Frame: up to week 3 ]
- Clinical measures (SSRS, SSR, BL-VAS, BDI-II) [ Time Frame: up to week 3 ]
|Study Start Date:||August 2006|
|Study Completion Date:||December 2007|
|Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
Drug: Pramipexole, Amisulpride
Please refer to this study by its ClinicalTrials.gov identifier: NCT00471588
|GSK Investigational Site|
|Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|