Obsessive-Compulsive DisorderPhase 2OCD-RTNCT06611592
Safety and Efficacy of Pramipexole Treatment in Resistant Obsessive-Compulsive Disorder (OCD)
A Phase 2 study testing Pramipexole 0.088mg/tid, Pramipexole 0.18 mg/tid and Pramipexole 0.35 mg/tid in people with Obsessive-Compulsive Disorder, run by Clinical Academic Center (2CA-Braga) at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- Pramipexole 0.088mg/tid, Pramipexole 0.18 mg/tid and Pramipexole 0.35 mg/tid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 sitePortugal
- Study dates
- 20 Aug 2024to 20 Aug 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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 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 cannot join
- 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);
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- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal1 site, 1 recruiting
- Recruiting
Clinical Academic Center - Braga (2CA-Braga)
Braga, 4710-243
Pedro Morgado, MD, PhD, +351253027249, pedromorgado@med.uminho.pt
Pedro Morgado, MD, PhD
About this study
Official title: Safety and Efficacy of Pramipexole Treatment in Resistant Obsessive-Compulsive Disorder (OCD): Pilot, Randomized and Controlled Clinical 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.
Read the detailed description
Phase 2 clinical trial, randomized, with three-parallel-groups, lasting 26 weeks (screening phase, 4 weeks + treatment phase, 16 weeks + follow-up phase, 6 weeks), whose primary objective is to evaluate the effectiveness of using pramipexole as a strategy for boosting SSRIs, in three different doses, in treatment of resistant OCD.
The main endpoint is the measurement of the difference in the total score of the Y-BOCS scale between baseline (V1; before intervention with the investigational drug) and week 16 (V9; after intervention with the investigational drug), between the different groups treated with different doses of pramipexole.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- Pramipexole 0.088mg/tid, Pramipexole 0.18 mg/tid, Pramipexole 0.35 mg/tid
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pramipexole 0.088mg/tidDrug
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/tidDrug
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/tidDrug
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 group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: 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) Receives: Drug: Pramipexole 0.35 mg/tid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline and Week 16
Secondary outcomes (1)
Number of adverse events observed
Number of adverse events observed (nonserious, serious not related to the investigational medicinal product, and serious related to the investigational medicinal product)
Measured: From Day 2 (after the first dose of the investigational drug) until Week 22 (end of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start20 Aug 2024
- Primary completion20 Aug 2028 (estimated)
- Study completion20 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinical Academic Center (2CA-Braga)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pedro Morgado, MD, PhD, Principal investigator, 2CA-Braga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06611592
- Sponsor's protocol ID
- OCD_rt
- Other IDs
- 2024-511085-37-00
- Acronym
- OCD-RT
- Status last verified
- Jan 2025
- First submitted
- 4 Sep 2024
- Last updated
- 6 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Pramipexole Treatment in Resistant Obsessive-Compulsive Disorder (OCD): Pilot, Randomized and Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06611592
- Acronym / sponsor ID
- OCD-RT / OCD_rt
- Conditions
- Obsessive-Compulsive Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Clinical Academic Center (2CA-Braga)University, hospital or other
- Study start
- 20 Aug 2024 (actual)
- Primary completion
- 20 Aug 2028 (estimated)
- Study completion
- 20 Aug 2028 (estimated)
- First posted
- 25 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Phase 2 clinical trial, randomized, with three-parallel-groups, lasting 26 weeks (screening phase, 4 weeks + treatment phase, 16 weeks + follow-up phase, 6 weeks), whose primary objective is to evaluate the effectiveness of using pramipexole as a strategy for boosting SSRIs, in three different doses, in treatment of resistant OCD.
The main endpoint is the measurement of the difference in the total score of the Y-BOCS scale between baseline (V1; before intervention with the investigational drug) and week 16 (V9; after intervention with the investigational drug), between the different groups treated with different doses of pramipexole.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pramipexole at a dose of 0.088 mg/tid | Experimental | Drug: Pramipexole 0.088mg/tidTreatment with antidepressant and pramipexole at a dose of 0.088 mg/tid (0.125 mg of salt) |
| Pramipexole at a dose of 0.18 mg/tid | Experimental | Drug: Pramipexole 0.18 mg/tidTreatment with antidepressant and pramipexole at a dose of 0.18 mg/tid (0.25 mg of salt) |
| Pramipexole at a dose of 0.35 mg/tid | Experimental | Drug: Pramipexole 0.35 mg/tidTreatment with antidepressant and pramipexole at a dose of 0.35 mg/tid (0.50 mg of salt) |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (19 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pramipexole 0.088mg/tidWeek 1 - Week 16 (end of treatment): Oral administration of 0.088 mg/tid dose of pramipexole (0.125 mg of salt). | Drug | Pramipexole at a dose of 0.088 mg/tid |
| Pramipexole 0.18 mg/tidWeek 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 at a dose of 0.18 mg/tid |
| Pramipexole 0.35 mg/tidWeek 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). | Drug | Pramipexole at a dose of 0.35 mg/tid |
Primary outcome
Difference between baseline and after treatment in Y-BOCS total score
Time frame: Baseline and Week 16
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).
1 secondary outcome
Number of adverse events observed
Time frame: From Day 2 (after the first dose of the investigational drug) until Week 22 (end of study)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pedro Morgado, MD, PhD principal investigator
2CA-Braga
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pramipexole 0.088mg/tid, Pramipexole 0.18 mg/tid and Pramipexole 0.35 mg/tid in people with Obsessive-Compulsive Disorder, run by Clinical Academic Center (2CA-Braga) at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mónica Gonçalves (+351 253 027 249, 2ca@ccabraga.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference between baseline and after treatment in Y-BOCS total score (time frame: Baseline and Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2025; AzTrials last refreshed its copy on 8 Nov 2026.