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

Sponsor
Clinical Academic Center (2CA-Braga)
Study ID
NCT06611592
Phase
PHASE2
Status
Recruiting
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Conditions

  • Obsessive-Compulsive Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Not accepted

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 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 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).

Study Details

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.

Key Dates

First listed
Sep 25, 2024
Start date
Aug 20, 2024
Status verified
Jan 2025
Primary completion
Aug 20, 2028
Completion
Aug 20, 2028

Study Design

Enrollment
48 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Pramipexole at a dose of 0.088 mg/tid
    Treatment with antidepressant and pramipexole at a dose of 0.088 mg/tid (0.125 mg of salt)
  • Experimental: Pramipexole at a dose of 0.18 mg/tid
    Treatment with antidepressant and pramipexole at a dose of 0.18 mg/tid (0.25 mg of salt)
  • Experimental: Pramipexole at a dose of 0.35 mg/tid
    Treatment with antidepressant and pramipexole at a dose of 0.35 mg/tid (0.50 mg of salt)

Primary Outcome Measure

Difference between baseline and after treatment in Y-BOCS total score [ Time Frame: Baseline and Week 16 ]

Central Contacts

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