Safety and Efficacy of Pramipexole Treatment in Resistant Obsessive-Compulsive Disorder (OCD)

Launched by CLINICAL ACADEMIC CENTER (2CA-BRAGA) · Sep 23, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called pramipexole to see if it can help people with obsessive-compulsive disorder (OCD) who have not responded well to other treatments. The usual treatments for OCD include certain antidepressants and sometimes additional medications called antipsychotics. However, many patients still struggle to find relief from their symptoms. This trial aims to evaluate how safe and effective pramipexole is for those who have not benefited from these standard treatments.

To participate in this study, individuals need to be between 18 and 64 years old, speak European Portuguese, and have a diagnosis of OCD that hasn't improved despite trying at least two different antidepressants and possibly antipsychotics. Participants can expect regular check-ins to monitor their progress and any side effects from the medication. It's important to note that certain conditions, like a history of psychotic illnesses or current severe heart problems, would exclude someone from joining the trial. If you or someone you know is struggling with treatment-resistant OCD, this study may provide an opportunity to explore a new option.

Gender

ALL

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).