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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00471588
First received: May 8, 2007
Last updated: September 11, 2014
Last verified: September 2014

May 8, 2007
September 11, 2014
August 2006
December 2007   (final data collection date for primary outcome measure)
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 ]
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: will occur on Wk 1, 2 and 3 ]
Complete list of historical versions of study NCT00471588 on ClinicalTrials.gov Archive Site
  • 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 ]
Test the prediction that a dopamine D2/D3 agonist drug (pramipexole)by PK levels. PK sample taken on Week 1 only. [ Time Frame: taken on Week 1 only. ]
Not Provided
Not Provided
 
Characterize The Modulatory Effects Of Dopamine D2/D3 Receptor Agonist And Antagonist Drugs On Compulsive Behaviors
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Obsessive-Compulsive Disorder
Drug: Pramipexole, Amisulpride
Study Drug
Other Names:
  • Pramipexole
  • Amisulpride
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
December 2007
December 2007   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00471588
TMT106512
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP