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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
52
Study Drug
GSK Investigational Site
Cambridge, Cambridgeshire, United Kingdom
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
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