RecruitingPhase 2NCT06611592

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

Safety and Efficacy of Pramipexole Treatment in Resistant Obsessive-Compulsive Disorder (OCD): Pilot, Randomized and Controlled Clinical Trial


Sponsor

Clinical Academic Center (2CA-Braga)

Enrollment

48 participants

Start Date

Aug 20, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 64 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether pramipexole — a medication normally used for Parkinson's disease — can help people with obsessive-compulsive disorder (OCD) who haven't responded well to standard treatments. OCD causes repeated, unwanted thoughts and the urge to perform rituals, and some cases are very hard to treat. **You may be eligible if...** - You are between 18 and 64 years old - Your native language is European Portuguese - You have been diagnosed with OCD - Your OCD symptoms are severe (score of 16 or higher on the standard OCD rating scale) - You have tried at least one standard OCD treatment (like an SSRI) without enough improvement **You may NOT be eligible if...** - You have a history of bipolar disorder or psychosis - You are pregnant or breastfeeding - You have certain heart conditions or other medical problems that make the medication unsafe - You are currently taking medications that could interact with pramipexole Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGPramipexole 0.088mg/tid

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

DRUGPramipexole 0.18 mg/tid

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).

DRUGPramipexole 0.35 mg/tid

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).


Locations(1)

Clinical Academic Center - Braga (2CA-Braga)

Braga, Portugal

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06611592


Related Trials