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Completed

NCT Number: NCT00471588

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site

Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pramipexole, Amisulpride

Drug

Study Drug

Other names: Pramipexole, Amisulpride

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. Measure of brain functional activation at rest.

    Time frame: up to week 3

  3. Measure of behavioural performance

    Time frame: up to week 3

  4. Measure of peripheral blood for gene expression and proteomic changes.

    Time frame: up to week 3

  5. Genetic variation in selected genes

    Time frame: up to week 3

  6. Clinical measures (SSRS, SSR, BL-VAS, BDI-II)

    Time frame: up to week 3

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
May 10, 2007
Registry last updated
Sep 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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