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Tests treatment safety and results for Obsessive-Compulsive Disorder
Official title Safety and Efficacy of Pramipexole Treatment in Resistant Obsessive-Compulsive Disorder (OCD)
ClinicalTrials.gov ID: NCT06611592
What this study is testing
What is Pramipexole 0.088mg/tid?
Pramipexole 0.088mg/tid is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for obsessive-compulsive disorder.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 64
You may be able to join 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: 5.1 Patients who do not respond to treatment with at least two selective serotonin reuptake...
You likely can't join 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);
See the full eligibility criteria
- 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: 5.1 Patients who do not respond to treatment with at least two selective serotonin reuptake inhibitor antidepressants (SSRIs) at the maximum tolerated therapeutic...
- 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;
- Patients with creatinine clearance ≤ 50 ml/min (calculated by Cockcroft-Gault formula);
- Patients with NYHA III or IV heart failure or any other severe cardiovascular disease;
- Hypotension (\<90/60 mmHg) sitting position and hypotension orthostatic (drop in systolic AT ≥20 mmHg or diastolic AT ≥10 mmHg after 2-3 minutes of orthostatism) at the screening;
- Patients with contraindication to perform MRI cannot participate in the assessment of the exploratory endpoint (i.e., other pre-specified outcomes).
The study team makes the final eligibility decision.
Where it's taking place
- Braga, Portugal
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Braga, Portugal. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.