Clinical trial NCT05401019: Efficacy of Treatment With Pramipexole or Risperidone in Patients With Refractory Obsessive-compulsive Disorder (OCD)
Official title: Efficacy of Treatment With Pramipexole or Risperidone in Patients With Refractory Obsessive-compulsive Disorder (OCD): Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Obsessive-Compulsive Disorder
Lead sponsor: Clinical Academic Center (2CA-Braga)
Sponsor class: OTHER
Collaborators: name: University of Minho
First posted: 2022-06-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).


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 who do not respond to treatment with at least two selective serotonin reuptake inhibitor antidepressants (SSRIs) at the maximum tolerated therapeutic dose with or without psychotherapy, i.e. patients in whom there is no reduction in the Y-BOCS score by 25% to 35% relative to the score obtained before starting treatment with SSRIs (Rauch \& Jenike, 1994).

Exclusion Criteria:

1. Patients who have a complete response to drug treatment with or without psychotherapy, i.e. patients with a reduction in Y-Bocs score by 25% to 35% regarding the score obtained before starting treatment with SSRIS (Rauch \& Jenike, 1994);
2. Patients with current or anterior history of psychotic illness (schizophrenia, delusions, among others);
3. Patients with bipolar disorder;
4. Patients with tick disorder;
5. Patients with borderline personality disorder;
6. Patients with social anxiety disorder;
7. Patients with current or anterior history of dietary behavior disorders (at least in the last 6 months);
8. patients with a history of neurological disease or traumatic brain injury;
9. Patients with history of alcohol abuse or illicit substances (at least in the last 6 months);
10. patients who are passing or have passed in the last 6 months by a major depressive episode;
11. Patients that undergo deep brain stimulation;
12. Presence of sensory deficits impeding participation in clinical study;
13. Pregnant or in breastfeeding period;
14. Patients doing medication or receiving prohibited treatments;
15. Patients with contraindication to perform MRI.

Primary outcomes:
measure: Y-BOCS total score
timeFrame: Change from Baseline Y-BOCS total score at visit 9 (16 weeks)
Secondary outcomes:
measure: Safety outcomes
timeFrame: Change from Baseline at visit 9 (16 weeks)
measure: Biochemical parameters
timeFrame: Change from Baseline at visit 9 (16 weeks)
measure: Neurobiological parameters
timeFrame: Change from Baseline at visit 9 (16 weeks)
measure: Scores of the 4 subscales of the WHOQOL-bref
timeFrame: Change from Baseline at visit 9 (16 weeks)
measure: OCI-R Total score
timeFrame: Change from Baseline at visit 9 (16 weeks)
measure: PSS-10 Total score
timeFrame: Change from Baseline at visit 9 (16 weeks)
measure: HAM-A Total score
timeFrame: Change from Baseline at visit 9 (16 weeks)
measure: HAM-D Total score
timeFrame: Change from Baseline at visit 9 (16 weeks)
Other outcomes:
Locations:
Study officials:
References: