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

This study has been completed.
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: May 8, 2007
Last updated: September 11, 2014
Last verified: September 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 Intervention Phase
Obsessive-Compulsive Disorder
Drug: Pramipexole, Amisulpride
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 52
Study Start Date: August 2006
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Pramipexole, Amisulpride
    Study Drug
    Other Names:
    • Pramipexole
    • Amisulpride

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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 Criteria:

  • 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.
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Please refer to this study by its identifier: NCT00471588

United Kingdom
GSK Investigational Site
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline Identifier: NCT00471588     History of Changes
Other Study ID Numbers: TMT106512
Study First Received: May 8, 2007
Last Updated: September 11, 2014

Keywords provided by GlaxoSmithKline:
stimulant users

Additional relevant MeSH terms:
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Compulsive Behavior
Personality Disorders
Mental Disorders
Anxiety Disorders
Impulsive Behavior
Dopamine Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agonists
Neurotransmitter Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Antidepressive Agents, Second-Generation
Antidepressive Agents
Cardiotonic Agents
Autonomic Agents processed this record on April 26, 2017