Using Pramipexole to Treat Resistant Obsessive-Compulsive Disorder

Safety and Efficacy of Pramipexole Treatment in Resistant Obsessive-Compulsive Disorder (OCD): Pilot, Randomized and Controlled Clinical Trial

This study is testing if the medication pramipexole can help people with obsessive-compulsive disorder who haven't found relief from other treatments.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Ages: 18 Years to 64 Years
• Sex: All
• Sponsor: Clinical Academic Center (2CA-Braga) (Academic / other)
• Locations: 1 site (Braga)
• Trial ID: NCT06611592 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the safety and efficacy of pramipexole, a dopaminergic receptor agonist, in patients with resistant obsessive-compulsive disorder (OCD). It is a Phase 2, randomized trial with three parallel groups, lasting 26 weeks, which includes a screening phase, treatment phase, and follow-up phase. The primary objective is to evaluate the effectiveness of pramipexole in boosting the effects of selective serotonin reuptake inhibitors (SSRIs) in patients who have not responded to previous treatments. Participants will be assessed using the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) to measure changes in their symptoms.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 64 with a diagnosis of OCD who have not responded to at least two SSRIs and an antipsychotic.

Not a fit: Patients who have not been diagnosed with OCD or those who have not tried previous treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new option for patients with OCD who have not responded to existing therapies.

How similar studies have performed: While pramipexole has shown benefits in resistant depression, its application in OCD is less established, making this approach novel.

Eligibility criteria

Inclusion Criteria:

1. Age between 18 and 64 years;
2. European Portuguese as mother tongue;
3. Patients diagnosed with OCD, regardless of subtype, according to DSM-5 and/or ICD-10 criteria;
4. Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score ≥ 16;
5. Patients resistant to the first-line treatment for OCD:

5.1 Patients who do not respond to treatment with at least two selective serotonin reuptake inhibitor antidepressants (SSRIs) at the maximum tolerated therapeutic dose during at least 12 weeks, i.e. patients in whom there is no reduction in the Y-BOCS score by 25% relative to the score obtained before starting treatment with SSRIs.

5.2 Patients who do not respond to treatment with risperidone or aripiprazole as potentiation of the SSRIs at the maximum tolerated therapeutic dose during at least 12 weeks, i.e. patients in whom there is no reduction in the Y-BOCS score by 25% relative to the score obtained before starting treatment with the antipsychotic or patients in whom the Y-BOCS score is kept ≥ 16 after the treatment with the antipsychotic.

Exclusion Criteria:

1. Patients with current or anterior history of psychotic illness (schizophrenia, delusions, among others);
2. Patients with bipolar disorder;
3. Patients with tick disorder;
4. Patients with borderline personality disorder;
5. Patients with social anxiety disorder;
6. Patients with current or anterior history of dietary behavior disorders (at least in the last 6 months);
7. Patients with a history of neurological disease or traumatic brain injury;
8. Patients with history of alcohol abuse or illicit substances (at least in the last 6 months);
9. Patients who are passing or have passed in the last 6 months by a major depressive episode;
10. Patients that undergo deep brain stimulation;
11. Presence of sensory deficits impeding participation in clinical study;
12. Pregnant or in breastfeeding period;
13. Patients who are doing or have done psychotherapy in the last 6 months;
14. Patients doing medication or receiving prohibited treatments;
15. Patients with allergy to pramipexole or any of the excipients;
16. Patients with creatinine clearance ≤ 50 ml/min (calculated by Cockcroft-Gault formula);
17. Patients with NYHA III or IV heart failure or any other severe cardiovascular disease;
18. Hypotension (\<90/60 mmHg) sitting position and hypotension orthostatic (drop in systolic AT ≥20 mmHg or diastolic AT ≥10 mmHg after 2-3 minutes of orthostatism) at the screening;
19. Patients with contraindication to perform MRI cannot participate in the assessment of the exploratory endpoint (i.e., other pre-specified outcomes).

Where this trial is running

Braga

• Clinical Academic Center - Braga (2CA-Braga) — Braga, Portugal (Recruiting)

Study contacts

• Principal investigator: Pedro Morgado, MD, PhD — 2CA-Braga
• Study coordinator: Mónica Gonçalves

Conditions Obsessive-Compulsive Disorder