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.
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 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;
Parallel
Pramipexole 0.088mg/tid
DrugWeek 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/tid
DrugWeek 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/tid
DrugWeek 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).
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)
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.
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.
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.
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).
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