Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

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

Q: Who can participate in NCT06611592?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

Q: How do I contact the trial site for NCT06611592?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Q: Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Q: Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

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

Safety and Efficacy of Pramipexole Treatment in Resistant Obsessive-Compulsive Disorder (OCD) (NCT06611592) is a Phase 2 interventional studying Obsessive-Compulsive Disorder, sponsored by Clinical Academic Center (2CA-Braga). RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Obsessive-Compulsive Disorder and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 48 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Age between 18 and 64 years; 2. European Portuguese as mother tongue; 3. Patients diagnosed with OCD, regardless of subtype, according to DSM-5 and/or ICD-10 criteria; 4. Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score ≥ 16; 5. 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 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. 5.2 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. Who Should NOT Join This Trial: 1. Patients with current or anterior history of psychotic illness (schizophrenia, delusions, among others); 2. Patients with bipolar disorder; 3. Patients with tick disorder; 4. Patients with borderline personality disorder; 5. Patients with social anxiety disorder; 6. Patients with current or anterior history of dietary behavior disorders (at least in the last 6 months); 7. Patients with a history of neurological disease or traumatic brain injury; 8. Patients with history of alcohol abuse or illicit substances (at least in the last 6 months); 9. Patients who are passing or have passed in the last 6 months by a major depressive episode; 10. Patients that undergo deep brain stimulation; 11. Presence of sensory deficits impeding participation in clinical study; 12. Pregnant or in breastfeeding period; 13. Patients who are doing or have done psychotherapy in the last 6 months; ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: 1. Age between 18 and 64 years; 2. European Portuguese as mother tongue; 3. Patients diagnosed with OCD, regardless of subtype, according to DSM-5 and/or ICD-10 criteria; 4. Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score ≥ 16; 5. 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 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. 5.2 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. Exclusion Criteria: 1. Patients with current or anterior history of psychotic illness (schizophrenia, delusions, among others); 2. Patients with bipolar disorder; 3. Patients with tick disorder; 4. Patients with borderline personality disorder; 5. Patients with social anxiety disorder; 6. Patients with current or anterior history of dietary behavior disorders (at least in the last 6 months); 7. Patients with a history of neurological disease or traumatic brain injury; 8. Patients with history of alcohol abuse or illicit substances (at least in the last 6 months); 9. Patients who are passing or have passed in the last 6 months by a major depressive episode; 10. Patients that undergo deep brain stimulation; 11. Presence of sensory deficits impeding participation in clinical study; 12. Pregnant or in breastfeeding period; 13. Patients who are doing or have done psychotherapy in the last 6 months; 14. Patients doing medication or receiving prohibited treatments; 15. Patients with allergy to pramipexole or any of the excipients; 16. Patients with creatinine clearance ≤ 50 ml/min (calculated by Cockcroft-Gault formula); 17. Patients with NYHA III or IV heart failure or any other severe cardiovascular disease; 18. 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; 19. Patients with contraindication to perform MRI cannot participate in the assessment of the exploratory endpoint (i.e., other pre-specified outcomes).

Treatments Being Tested

DRUG

Pramipexole 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).

DRUG

Pramipexole 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).

DRUG

Pramipexole 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)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Clinical Academic Center - Braga (2CA-Braga)

Braga, Portugal

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06611592), the sponsor (Clinical Academic Center (2CA-Braga)), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06611592 clinical trial studying?

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 … The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06611592?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06611592?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06611592. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06611592. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.