drugset / Trial / NCT05401019
Efficacy of Treatment With Pramipexole or Risperidone in Patients With Refractory Obsessive-compulsive Disorder (OCD)
RandomizedParallel-groupSingle-blindTreatment
Summary
This is a phase 2, randomized, controlled clinical trial to study the efficacy of pramipexol or risperidone in the treatment of refractory ODC patients. This study is a two-parallel-group clinical trial with duration of 28 weeks (recruitment phase, 4 weeks + treatment phase, 16 weeks + follow-up phase, 8 weeks. The primary endpoint of this study is the score in the Y-BOCS scale measured between baseline and EOT ( at week 16).
Timeline
- Start
- 2022-06
- Primary completion
- 2026-12
- Completion
- 2026-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pramipexole | Unknown | 0.088 mg | Oral |
| Subject | Pramipexole | Unknown | 0.18 mg | Oral |
| Subject | Pramipexole | Unknown | 0.35 mg | Oral |
| Subject | Pramipexole | Unknown | 0.53 mg | Oral |
| Comparator | Risperidone | Other / unclassified | 0.5 mg | Oral |
| Comparator | Risperidone | Other / unclassified | 1 mg | Oral |
| Comparator | Risperidone | Other / unclassified | 1.5 mg | Oral |
| Comparator | Risperidone | Other / unclassified | 2 mg | Oral |