Characterize The Modulatory Effects Of Dopamine D2/D3 Receptor Agonist And Antagonist Drugs On Compulsive Behaviors
|ClinicalTrials.gov Identifier: NCT00471588|
Recruitment Status : Completed
First Posted : May 10, 2007
Last Update Posted : September 15, 2014
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 or disease||Intervention/treatment||Phase|
|Obsessive-Compulsive Disorder||Drug: Pramipexole, Amisulpride||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||52 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Study Start Date :||August 2006|
|Actual Primary Completion Date :||December 2007|
|Actual Study Completion Date :||December 2007|
- Drug: Pramipexole, Amisulpride
Study DrugOther Names:
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00471588
|GSK Investigational Site|
|Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|