Efficacy of Treatment With Pramipexole or Risperidone in Patients With Refractory Obsessive-compulsive Disorder (OCD)

NCT05401019 | Withdrawn Phase 2 DMC

• 2 other identifiers: OCD-RT2022-000249-34
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Obsessive-Compulsive Disorder

Outcome Measures

Primary Outcomes (1)

• Y-BOCS total score

  Yale-Brown Obsessive Compulsive Scale (Y-BOCS) total score. The Y-BOCS scale measures obsessions separately from compulsions and specifically measures the severity of symptoms of obsessive-compulsive disorder without being biased towards or against the type of content the obsessions or compulsions might present. This instrument consists of 10 self-report items (5 items for obsessions, 5 items for compulsions) that estimate the degree of severity of symptoms (subclinical, mild, moderate, severe or extreme) on a Likert scale ranging from 0 (no symptoms) and 4 (extreme). The final score is calculated as the total sum of all items: subclinical (0 - 7 points), mild (8 - 15 points), moderate (16 - 23 points), severe (24-31) and extreme (32 - 40 points). In the final score, 16 is the cut-off point for symptom severity to be indicative of OCD

  Change from Baseline Y-BOCS total score at visit 9 (16 weeks)

Secondary Outcomes (8)

• Safety outcomes

  Change from Baseline at visit 9 (16 weeks)

• Biochemical parameters

  Change from Baseline at visit 9 (16 weeks)

• Neurobiological parameters

  Change from Baseline at visit 9 (16 weeks)

• Scores of the 4 subscales of the WHOQOL-bref

  Change from Baseline at visit 9 (16 weeks)

• OCI-R Total score

  Change from Baseline at visit 9 (16 weeks)

Study Arms (2)

Experimental arm

EXPERIMENTAL

Treatment with pramipexol, once a day, tablet of 0.088, 0.18, 0.35, 0.53 mg per day during 16 weeks

Drug: Pramipexole

Control arm

ACTIVE COMPARATOR

Treatment with Risperidone, once a day, tablet of 0.5, 1, 1.5, 2 mg per day during 16 weeks + 8 weeks follow-up.

Drug: Risperidone

Interventions

Pramipexole DRUG

Oral medication, once a day during 16 weeks

Experimental arm

Risperidone DRUG

Oral medication, once a day during 16 weeks

Control arm

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 18 and 64 years;
• European Portuguese as mother tongue;
• Patients diagnosed with OCD, regardless of subtype, according to DSM-5 and/or ICD-10 criteria;
• Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score ≥ 16;
• 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).

You may not qualify if:

• 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);
• Patients with current or anterior history of psychotic illness (schizophrenia, delusions, among others);
• Patients with bipolar disorder;
• Patients with tick disorder;
• Patients with borderline personality disorder;
• Patients with social anxiety disorder;
• Patients with current or anterior history of dietary behavior disorders (at least in the last 6 months);
• patients with a history of neurological disease or traumatic brain injury;
• Patients with history of alcohol abuse or illicit substances (at least in the last 6 months);
• patients who are passing or have passed in the last 6 months by a major depressive episode;
• Patients that undergo deep brain stimulation;
• Presence of sensory deficits impeding participation in clinical study;
• Pregnant or in breastfeeding period;
• Patients doing medication or receiving prohibited treatments;
• Patients with contraindication to perform MRI.

Sponsors & Collaborators

• Clinical Academic Center (2CA-Braga): lead
• University of Minho: collaborator

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Pramipexole; Risperidone

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzothiazoles; Thiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pyrimidinones; Pyrimidines

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2022
• First Posted: June 2, 2022
• Study Start: June 1, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 19, 2024

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share