A Phase 2 interventional study of Pramipexole 0.088mg/tid and Pramipexole 0.18 mg/tid in Obsessive-Compulsive Disorder, sponsored by Clinical Academic Center (2CA-Braga). Recruiting at 1 site in Portugal. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2025-01-06.
Sponsored by Clinical Academic Center (2CA-Braga) · Phase 2, Interventional, and Treatment
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.
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.
367 studies on the registry are indexed under Compulsive Personality Disorder; 67 are open to participants now.
This study's planned enrollment of 48 is above the median of 37 across 306 interventional studies indexed under Compulsive Personality Disorder.
Browse Compulsive Personality Disorder studies →Clinical Academic Center (2CA-Braga) is the lead sponsor of 7 studies on the registry; 4 are open to participants now.
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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:
Treatment with antidepressant and pramipexole at a dose of 0.088 mg/tid (0.125 mg of salt)
Drug: Pramipexole 0.088mg/tid
Treatment with antidepressant and pramipexole at a dose of 0.18 mg/tid (0.25 mg of salt)
Drug: Pramipexole 0.18 mg/tid
Treatment with antidepressant and pramipexole at a dose of 0.35 mg/tid (0.50 mg of salt)
Drug: Pramipexole 0.35 mg/tid
Week 1 - Week 16 (end of treatment): Oral administration of 0.088 mg/tid dose of pramipexole (0.125 mg of salt).
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).
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).
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).
Time frame: Baseline and Week 16
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)
Time frame: From Day 2 (after the first dose of the investigational drug) until Week 22 (end of study)
OCI-R Total score
Obsessive-Compulsive Inventory-Revised (OCI-R) is a self-report instrument that assesses the symptoms of OCD during the last month through 18 statements that are related to everyday situations. The total score ranges from 0 to 72 points. Higher scores on this scale indicate higher severity of OCD symptoms.
Time frame: Baseline, Day 1, Day 28, Week 8, Week 12, Week 16, Week 18 and Week 22
Scores of the 4 subscales of the WHOQOL-bref
The Quality of Life Scale (WHOQOL-bref) is an instrument that assesses four conceptual domains of quality of life: material and physical well-being, relationships with other people, psychological well-being and environment. This self-report instrument, consisting of a brief sociodemographic questionnaire and 26 statements, quantifies global cognitive judgments of life satisfaction.
Time frame: Baseline (before intervention), Week 16 (after intervention ), and Week 22 (end of study)
HAM-D Total score
Hamilton Depression Rating Scale (HAM-D) instrument to measure the psychic and somatic components of depression. From 0 - 7 the participant is considered asymptomatic, while a score equal to or greater than 20 indicates the presence of depressive symptoms. The higher the value, the greater the severity of the symptoms, ranging from moderate to severe.
Time frame: Baseline, Day 1, Day 7, Day 14, Day 21, Day 28, Week 8, Week 12, Week 16, Week 18 and Week 22
HAM-A Total score
Hamilton Anxiety Rating Scale (HAM-A) instrument to measure the psychic and somatic components of anxiety. The final scores indicate: mild anxiety (0 - 17 points), moderate anxiety (18 - 24 points) and potentially worrying levels of anxiety (25 - 30 points).
Time frame: Baseline, Day 1, Day 7, Day 14, Day 21, Day 28, Week 8, Week 12, Week 16, Week 18 and Week 22
PSS-10 Total score
Perceived Stress Scale (PSS-10) is a self-report questionnaire to assess perceived stress during the last month. The total score can vary between 0 and 40 points. A higher total score indicates higher levels of perceived stress.
Time frame: Baseline, Day 1, Day 28, Week 8, Week 12, Week 16, Week 18 and Week 22
SIQ total score
The Suicidal Ideation Questionnaire (SIQ) assesses thoughts and cognitions about suicide and death over the past month. Higher scores in the SIQ scale represent greater severity of suicidal ideation. The total score ranges from 0 to 180 points.
Time frame: Baseline, Day 1, Day 7, Day 14, Day 21, Day 28, Week 8, Week 12, Week 16, Week 18 and Week 22
Neurobiological parameters - Cortical thickness
Anatomical sequence (Magnetization Prepared - RApid Gradient Echo) to assess cortical thickness
Time frame: Baseline (before intervention) and Week 16 (after intervention with the investigational drug).
Neurobiological parameters - Functional connectivity
Functional sequences (Echo-planar imaging) at rest to assess functional connectivity of neural networks and static and dynamic connectivity
Time frame: Baseline (before intervention) and Week 16 (after intervention with the investigational drug).
Neurobiological parameters - Brain activity
Functional sequences (Echo-planar imaging) during an emotional processing task to assess brain activation during emotional processing
Time frame: Baseline (before intervention) and Week 16 (after intervention with the investigational drug).
Neurobiological parameters - Diffusion
Diffusion sequences (Diffusion Weighted Imaging) to measure mean diffusivity (MD), fractional anisotropy (FA), axial diffusivity (AD) and radial diffusivity (RD), in order to assess white matter integrity.
Time frame: Baseline (before intervention) and Week 16 (after intervention with the investigational drug).
Biochemical parameters - Complete blood count
Blood samples will be collected to measure the complete blood count.
Time frame: Baseline (before intervention ), Week 16 (after intervention) and Week 22 (end of the study)
Biochemical parameters - Cortisol
Blood samples will be collected to measure the cortisol.
Time frame: Baseline (before intervention ), Week 16 (after intervention) and Week 22 (end of the study)
Biochemical parameters - ACTH
Blood samples will be collected to measure the adrenocorticotropic hormone (ACTH).
Time frame: Baseline (before intervention ), Week 16 (after intervention) and Week 22 (end of the study)
Biochemical parameters - T4
Blood samples will be collected to measure the thyroxine (T4).
Time frame: Baseline (before intervention ), Week 16 (after intervention) and Week 22 (end of the study)
Biochemical parameters - TSH
Blood samples will be collected to measure the thyroid stimulating hormone (TSH).
Time frame: Baseline (before intervention ), Week 16 (after intervention) and Week 22 (end of the study)
Biochemical parameters - creatinine
Blood samples will be collected to measure the creatinine.
Time frame: Baseline (before intervention ), Week 16 (after intervention) and Week 22 (end of the study)
Biochemical parameters - glucose
Blood samples will be collected to measure the glucose.
Time frame: Baseline (before intervention ), Week 16 (after intervention) and Week 22 (end of the study)
Biochemical parameters - glycated hemoglobin
Blood samples will be collected to measure the glycated hemoglobin.
Time frame: Baseline (before intervention ), Week 16 (after intervention) and Week 22 (end of the study)
Biochemical parameters - Prolactin
Blood samples will be collected to measure the prolactin.
Time frame: Baseline (before intervention ), Week 16 (after intervention) and Week 22 (end of the study)
Plan to share: No
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Compulsive Personality Disorder→
Clinical Academic Center (2CA-Braga)