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Safety and Efficacy of Pramipexole Treatment in Resistant Obsessive-Compulsive Disorder (OCD): Pilot, Randomized and Controlled Clinical Trial
EU CTIS ID: 2024-511085-37-00
What this study is testing
Evaluate the effectiveness of using pramipexole as a strategy for boosting SSRIs, in three different doses, in the treatment of resistant OCD.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients diagnosed with OCD according to DSM-5 and/or ICD-10 criteria.
- Age between 18 and 64 years old
- European Portuguese as mother tongue
- Score ≥ 16 on the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)
- Have demonstrated resistance to first-line treatments for OCD, as defined by: Lack of response to pharmacological treatment with at least two selective serotonin reuptake inhibitors (SSRIs) at the maximum tolerated therapeutic dose (Fluoxetine 40-60mg/day; Fluvoxamine 100-300mg/day; Escitalopram 10-30mg/day; Citalopram 20-60 mg/day; Paroxetine 40-60mg/day and Sertraline 100-300mg/day) for at least 12 weeks, i.e., patients who show less than a 25% reduction in Y-BOCS score compared to the score obtained before starting SSRI treatment or patients who maintain a score ≥ 16 on the Y-BOCS after SSRI treatment; and Lack of response to pharmacological treatment with risperidone or aripiprazole as augmentation of SSRIs at the maximum tolerated therapeutic dose (Risperidone 0.5-4 mg/day, Aripiprazole 5-15 mg/day) for at least 6 to 12 weeks, i.e., patients who show less than a 25% reduction in Y-BOCS score compared to the score obtained before starting antipsychotic treatment or patients who maintain a score ≥ 16 on the Y-BOCS after antipsychotic treatment.
- In the case of participants of childbearing potential, it is necessary for them to consistently and correctly use one of the contraceptive methods presented in section 4.4.1.
You likely can't join if
- Patients with a current or previous history of psychotic illness (schizophrenia, delusions, among others)
- Hypotension (<90/60 mmHg) in the sitting position and orthostatic hypotension (drop in systolic BP ≥20 mmHg or diastolic BP ≥10 mmHg after 2-3 minutes in standing position) at the screening appointment;
- Patients with bipolar disorder
- Patients with tic disorders
- Patients with borderline personality disorder
- Patients with social anxiety disorder
See the full eligibility criteria
Who can join
- Patients diagnosed with OCD according to DSM-5 and/or ICD-10 criteria.
- Age between 18 and 64 years old
- European Portuguese as mother tongue
- Score ≥ 16 on the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)
- Have demonstrated resistance to first-line treatments for OCD, as defined by: Lack of response to pharmacological treatment with at least two selective serotonin reuptake inhibitors (SSRIs) at the maximum tolerated therapeutic dose (Fluoxetine 40-60mg/day; Fluvoxamine 100-300mg/day; Escitalopram 10-30mg/day; Citalopram 20-60 mg/day; Paroxetine 40-60mg/day and Sertraline 100-300mg/day) for at least 12 weeks, i.e., patients who show less than a 25% reduction in Y-BOCS score compared to the score obtained before starting SSRI treatment or patients who maintain a score ≥ 16 on the Y-BOCS after SSRI treatment; and Lack of response to pharmacological treatment with risperidone or aripiprazole as augmentation of SSRIs at the maximum tolerated therapeutic dose (Risperidone 0.5-4 mg/day, Aripiprazole 5-15 mg/day) for at least 6 to 12 weeks, i.e., patients who show less than a 25% reduction in Y-BOCS score compared to the score obtained before starting antipsychotic treatment or patients who maintain a score ≥ 16 on the Y-BOCS after antipsychotic treatment.
- In the case of participants of childbearing potential, it is necessary for them to consistently and correctly use one of the contraceptive methods presented in section 4.4.1.
What rules you out
- Patients with a current or previous history of psychotic illness (schizophrenia, delusions, among others)
- Hypotension (<90/60 mmHg) in the sitting position and orthostatic hypotension (drop in systolic BP ≥20 mmHg or diastolic BP ≥10 mmHg after 2-3 minutes in standing position) at the screening appointment;
- Patients with bipolar disorder
- Patients with tic disorders
- Patients with borderline personality disorder
- Patients with social anxiety disorder
- Patients with a current or previous history of eating disorder in the last 6 months
- Patients with a history of neurological disease or traumatic brain injury
- Patients with a history of alcohol or illicit substance abuse in the last 6 months
- Patients who are experiencing or have experienced a major depressive episode in the last 6 months
- Patients with contraindications to undergo MRI cannot participate in the assessment of the exploratory endpoint
- Patients undergoing deep brain stimulation
- Presence of sensory deficits that prevent participation in the clinical study
- Pregnant or breastfeeding women
- Patients who are undergoing or have undergone psychotherapy in the last 6 months
- Patients taking medication or receiving prohibited treatments
- Allergy to pramipexole and any of its excipients
- Patients with creatinine clearance ≤ 50 ml/min (calculated using the Cockcroft-Gault formula)
- Patients with NYHA III or IV heart failure or any other severe cardiovascular disease
The study team makes the final eligibility decision.
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, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.