Characterize The Modulatory Effects Of Dopamine D2/D3 Receptor Agonist And Antagonist Drugs On Compulsive Behaviors
- Conditions
- Obsessive-Compulsive Disorder
- Registration Number
- NCT00471588
- Lead Sponsor
- GlaxoSmithKline
- 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 Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 52
- Male or female, between 18 - 55 years of age; the groups will be matched for either handedness.
- Participants must have the ability to comprehend the key components of the consent form and provide informed consent.
- Participants must lead and write (in English) at a level sufficient to complete study related assessments.
- Assessment by a psychiatrist or psychologist, which includes a face-to-face evaluation of the individual using the DSM-VI diagnosis.
- No history of neurological disorder, head/brain injury, hepatitis, or visual impairment.
- No MRI contra-indications (metal in body, claustrophobia) and able to provide blood samples (venous accessibility, especially relevant for drug users).
- Patients with obsessive-compulsive disorder will have a minimum 2-year history of compulsive behaviours satisfying DSM-IV-TR criteria for OCD.
- Participants with chronic stimulant use will have a minimum 2-year history of dependence on class A stimulants, with age of drug abuse onset before 20 years, and will satisfy DSM-IV-TR criteria for dependence on stimulant drugs.
- Control volunteers have to be in good mental and physical health.
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A personal history of psychiatric or neurological disorders, as defined by the DSMIV (except OCD in patients with OCD and substance dependence in drug users)
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A history or presence of alcohol / substance abuse or dependence (other than nicotine), as defined by the DSM-IV-TR (except drug dependence group).
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A BDI-II total score greater than 14 will lead to exclusion from the study.
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Treatment with methadone or buprenorphine may interfere with the experimental tasks, and therefore, will lead to exclusion from the study.
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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.
- History of clinically significant or current renal dysfunction.
- Clinically significant abnormalities in hematology, blood chemistry, MRI, urinalysis or physical examination not resolved by baseline visit.
- Impaired liver function at baseline or history of liver dysfunction.
- Female participant is pregnant or currently breastfeeding.
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Any serious medical disorder or condition that would in the Investigator's opinion, preclude the administration of study medication and or a history of clinically significant hepatic, cardiac, renal, neurologic, cerebrovascular, metabolic or pulmonary disease.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method 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. on Wk 1, 2 and 3
- Secondary Outcome Measures
Name Time Method Measure of brain functional activation at rest. up to week 3 Test the prediction that a dopamine D2/D3 agonist drug (pramipexole)by PK levels. PK sample taken on Week 1 only. on Week 1 only. Measure of behavioural performance up to week 3 Genetic variation in selected genes up to week 3 Clinical measures (SSRS, SSR, BL-VAS, BDI-II) up to week 3 Measure of peripheral blood for gene expression and proteomic changes. up to week 3
Trial Locations
- Locations (1)
GSK Investigational Site
🇬🇧Cambridge, Cambridgeshire, United Kingdom