Actively Recruiting
Safety and Efficacy of Pramipexole Treatment in Resistant Obsessive-Compulsive Disorder (OCD) Pilot Randomized Controlled Clinical Trial with Three Dose Groups over 26 Weeks
Led by Clinical Academic Center (2CA-Braga) · Updated on 2025-01-06
48
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to explore the safety and effectiveness of pramipexole in treating patients with obsessive-compulsive disorder (OCD) who have not responded to standard treatments including selective serotonin reuptake inhibitors (SSRIs) and antipsychotics like risperidone and aripiprazole. The trial is a phase 2, randomized study involving patients diagnosed with resistant OCD, evaluating pramipexole as an add-on therapy to SSRIs to improve treatment outcomes. The study lasts 26 weeks and includes a 4-week screening phase, a 16-week treatment phase, and a 6-week follow-up phase. Participants are randomly assigned to one of three groups receiving different doses of pramipexole taken orally three times a day. Dosing starts at 0.088 mg and may increase to 0.18 mg or 0.35 mg tid depending on the assigned group, with dosages adjusted weekly during initial weeks and maintained through week 16. Participants will undergo evaluations to measure changes in OCD symptoms using the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) at the start and after 16 weeks of treatment. Safety and efficacy will be monitored throughout the study, including during follow-up. Researchers will compare symptom improvement between the different dose groups to assess pramipexole's potential benefit as an adjunct treatment for resistant OCD.
CONDITIONS
Official Title
Safety and Efficacy of Pramipexole Treatment in Resistant Obsessive-Compulsive Disorder (OCD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 64 years
- European Portuguese as mother tongue
- Diagnosed with obsessive-compulsive disorder (OCD) according to DSM-5 and/or ICD-10
- Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score of 16 or higher
- Resistant to first-line OCD treatment:
- No response to at least two SSRIs at maximum tolerated dose for at least 12 weeks (less than 25% reduction in Y-BOCS)
- No response to risperidone or aripiprazole added to SSRIs at maximum tolerated dose for at least 12 weeks (less than 25% reduction in Y-BOCS or Y-BOCS score remains 16 or higher)
You will not qualify if you...
- Current or past psychotic illness (e.g., schizophrenia, delusions)
- Bipolar disorder
- Tic disorder
- Borderline personality disorder
- Social anxiety disorder
- Current or past eating disorders within the last 6 months
- History of neurological disease or traumatic brain injury
- Alcohol abuse or illicit substance use within last 6 months
- Major depressive episode within last 6 months
- Undergoing deep brain stimulation
- Sensory deficits preventing participation
- Pregnant or breastfeeding
- Psychotherapy in last 6 months
- Taking prohibited medications or treatments
- Allergy to pramipexole or its ingredients
- Creatinine clearance 50 ml/min or less
- Severe heart failure (NYHA III or IV) or serious cardiovascular disease
- Hypotension at screening (sitting blood pressure below 90/60 mmHg or orthostatic hypotension)
- Contraindication to MRI for exploratory assessments
AI-Screening
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Trial Site Locations
Total: 1 location
1
Clinical Academic Center - Braga (2CA-Braga)
Braga, Portugal, 4710-243
Actively Recruiting
Research Team
M
Mónica Gonçalves
J
Joana Reis
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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