Clinical Trial: Characterize The Modulatory Effects Of Dopamine D2/D3 Receptor Agonist And Antagonist Drugs On Compulsive Behaviors

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 an

Brief Summary:

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.


Detailed Summary:
Sponsor: GlaxoSmithKline

Current Primary Outcome: 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 ]

Original Primary Outcome: 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: will occur on Wk 1, 2 and 3 ]

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Test the prediction that a dopamine D2/D3 agonist drug (pramipexole)by PK levels. PK sample taken on Week 1 only. [ Time Frame: taken on Week 1 only. ]

Information By: GlaxoSmithKline

Dates:
Date Received: May 8, 2007
Date Started: August 2006
Date Completion:
Last Updated: September 11, 2014
Last Verified: September 2014