NCT00471588

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

Completed Phase 1 Last updated 11 September 2014

What this trial tests

Phase 1 trial testing Pramipexole, Amisulpride in Obsessive-Compulsive Disorder in 52 participants. Completed in 1 December 2007.

Timeline

1 August 2006

Primary endpoint
1 December 2007

1 December 2007

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	treatment
Enrollment	52
Start date	1 August 2006
Primary completion	1 December 2007
Estimated completion	1 December 2007
Sites	1 location across United Kingdom

Drugs / interventions tested

• Pramipexole, Amisulpride — full drug profile →

Conditions studied

• Obsessive-Compulsive Disorder — all drugs for Obsessive-Compulsive Disorder →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 18 to 65, any sex, with Obsessive-Compulsive Disorder. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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

Sponsor's own 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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Use of functional imaging across clinical phases in CNS drug development.
   Borsook D, Becerra L, Fava M. · · 2013 · cited 46× · PMID 23860483 · DOI 10.1038/tp.2013.43
2. Amisulpride-induced acute akathisia in OCD: an example of dysfunctional dopamine-serotonin interactions?
   Ersche KD, Cumming P, Craig KJ, Müller U, et al · · 2012 · cited 5× · PMID 21746752 · DOI 10.1177/0269881111405363
3. Hereditary Patterns and Genetic Associations in Obsessive-Compulsive Disorder (OCD): Neuropsychiatric Insights, Genetic Influences, and Treatment Perspectives.
   Dhiman A, Mehan S, Khan Z, Tiwari A, et al · · 2025 · cited 4× · PMID 39219434 · DOI 10.2174/0115665232316708240828063527