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

NCT06611592 | Recruiting Phase 2

• 2 other identifiers: OCD_rt2024-511085-37-00
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The most common and effective treatment for OCD is pharmacological therapy that includes selective serotonin reuptake inhibitors (SSRIs) antidepressants and, in the case of patients resistant to this approach, a combination with antipsychotics. Risperidone and aripiprazole are atypical antipsychotics that act on dopamine (D2) and serotonin receptors. Studies have shown that these drugs are effective in boosting SSRIs for the treatment of OCD in resistant patients. Currently a high percentage of people diagnosed with OCD do not respond to the existing treatments. Pramipexole is a dopaminergic receptor agonist that specifically binds to dopamine D2 and D3 receptors, having demonstrated benefit in resistant depression. The aim of this clinical trial is to explore how pramipexole can act in the treatment of OCD in resistant patients, evaluating its safety and efficacy.

Conditions

Obsessive-Compulsive Disorder

Outcome Measures

Primary Outcomes (1)

• Difference between baseline and after treatment in Y-BOCS total score

  The measurement of the difference in the total score of the Y-BOCS scale between baseline (before intervention with the investigational drug) and after intervention with the investigational drug, between the different groups treated with different doses of pramipexole. 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. The final scores range from 0 to 40, with higher scores indicating higher symptom severity. The scores indicate subclinic (0 - 7 points), mild (8 - 15 points), moderate (16 - 23 points), severe (24 - 31 points), and extreme severity (32 - 40 points).

  Baseline and Week 16

Secondary Outcomes (1)

• Number of adverse events observed

  From Day 2 (after the first dose of the investigational drug) until Week 22 (end of study)

Other Outcomes (19)

• OCI-R Total score

  Baseline, Day 1, Day 28, Week 8, Week 12, Week 16, Week 18 and Week 22

• Scores of the 4 subscales of the WHOQOL-bref

  Baseline (before intervention), Week 16 (after intervention ), and Week 22 (end of study)

• HAM-D Total score

  Baseline, Day 1, Day 7, Day 14, Day 21, Day 28, Week 8, Week 12, Week 16, Week 18 and Week 22

Study Arms (3)

Pramipexole at a dose of 0.088 mg/tid

EXPERIMENTAL

Treatment with antidepressant and pramipexole at a dose of 0.088 mg/tid (0.125 mg of salt)

Drug: Pramipexole 0.088mg/tid

Pramipexole at a dose of 0.18 mg/tid

EXPERIMENTAL

Treatment with antidepressant and pramipexole at a dose of 0.18 mg/tid (0.25 mg of salt)

Drug: Pramipexole 0.18 mg/tid

Pramipexole at a dose of 0.35 mg/tid

EXPERIMENTAL

Treatment with antidepressant and pramipexole at a dose of 0.35 mg/tid (0.50 mg of salt)

Drug: Pramipexole 0.35 mg/tid

Interventions

Pramipexole 0.088mg/tid DRUG

Week 1 - Week 16 (end of treatment): Oral administration of 0.088 mg/tid dose of pramipexole (0.125 mg of salt).

Pramipexole at a dose of 0.088 mg/tid

Pramipexole 0.18 mg/tid DRUG

Week 1: oral administration of 0,088 mg/tid dose of pramipexole (0.125 mg salt). Week 2 -Week 16 (end of treatment): oral administration of 0.18 mg/tid dose of pramipexole (0.25 mg salt).

Pramipexole at a dose of 0.18 mg/tid

Pramipexole 0.35 mg/tid DRUG

Week 1: oral administration of 0,088 mg/tid dose of pramipexole (0.125 mg salt). Week 2: oral administration of a 0.18 mg/tid dose of pramipexole (0.25 mg salt). Week 3 - Week 16 (end of treatment): oral administration of a 0.35 mg/tid dose of pramipexole (0.50 mg salt).

Pramipexole at a dose of 0.35 mg/tid

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 resistant to the first-line treatment for OCD:
• 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.
• 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.

You may not qualify if:

• 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 who are doing or have done psychotherapy in the last 6 months;
• Patients doing medication or receiving prohibited treatments;
• Patients with allergy to pramipexole or any of the excipients;

Sponsors & Collaborators

• Clinical Academic Center (2CA-Braga): lead

Study Sites (1)

Clinical Academic Center - Braga (2CA-Braga)

Braga, 4710-243, Portugal

RECRUITING

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Pramipexole

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

Study Officials

• Pedro Morgado, MD, PhD

  2CA-Braga

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mónica Gonçalves

CONTACT

+351 253 027 249; 2ca@ccabraga.org

Joana Reis

CONTACT

+351 253 027 249; cro@ccabraga.org

Study Design

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

Study Record Dates

• First Submitted: September 4, 2024
• First Posted: September 25, 2024
• Study Start: August 20, 2024
• Primary Completion (Estimated): August 20, 2028
• Study Completion (Estimated): August 20, 2028
• Last Updated: January 6, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)