Status:
COMPLETED
Characterize The Modulatory Effects Of Dopamine D2/D3 Receptor Agonist And Antagonist Drugs On Compulsive Behaviors
Lead Sponsor:
GlaxoSmithKline
Conditions:
Obsessive-Compulsive Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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, dou...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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)
- A history or presence of alcohol / substance abuse or dependence (other than nicotine), as defined by the DSM-IV-TR (except drug dependence group).
- A BDI-II total score greater than 14 will lead to exclusion from the study.
- Treatment with methadone or buprenorphine may interfere with the experimental tasks, and therefore, will lead to exclusion from the study.
- 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.
- 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.
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT00471588
Start Date
August 1 2006
End Date
December 1 2007
Last Update
September 15 2014
Active Locations (1)
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1
GSK Investigational Site
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ