Last updated: 11/04/2018 12:50:37
Characterize The Modulatory Effects Of Dopamine D2/D3 Receptor Agonist And Antagonist Drugs On Compulsive Behaviors
GSK study ID
TMT106512
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
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.
Timeframe: on Wk 1, 2 and 3
Secondary outcomes:
Test the prediction that a dopamine D2/D3 agonist drug (pramipexole)by PK levels. PK sample taken on Week 1 only.
Timeframe: on Week 1 only.
Measure of brain functional activation at rest.
Timeframe: up to week 3
Measure of behavioural performance
Timeframe: up to week 3
Measure of peripheral blood for gene expression and proteomic changes.
Timeframe: up to week 3
Genetic variation in selected genes
Timeframe: up to week 3
Clinical measures (SSRS, SSR, BL-VAS, BDI-II)
Timeframe: up to week 3
Interventions:
Drug: Pramipexole, Amisulpride
Enrollment:
52
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Obsessive-Compulsive Disorder
Product
Not applicable
Collaborators
Not applicable
Study date(s)
August 2006 to December 2007
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 65 years
Accepts healthy volunteers
Yes
- 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.
- 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
Inclusion and exclusion criteria
Inclusion criteria:
- 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.
Male or female, between 18
55 years of age; the groups will be matched for either handedness.
Exclusion criteria:
- 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.
- 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.
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)
Female participant is pregnant or currently breastfeeding.
Trial location(s)
Location
GSK Investigational Site
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
Status
Recruiting
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2007-12-12
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website