Search / Trial NCT06611592

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

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

Apply for Trial

Trial Information

Current as of October 03, 2024

Recruiting

Keywords

Description

Phase 2 clinical trial, randomized, with three-parallel-groups, lasting 26 weeks (screening phase, 4 weeks + treatment phase, 16 weeks + follow-up phase, 6 weeks), whose primary objective is to evaluate the effectiveness of using pramipexole as a strategy for boosting SSRIs, in three different doses, in treatment of resistant OCD. The main endpoint is the measurement of the difference in the total score of the Y-BOCS scale between baseline (V1; before intervention with the investigational drug) and week 16 (V9; after intervention with the investigational drug), between the different groups...

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).

About Sponsor

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Braga, , Portugal

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0