Pramipexole dihydrochloride monohydrate for Obsessive-compulsive disorder

Inclusion criteria

• {"criterion_text":"- Patients diagnosed with OCD according to DSM-5 and/or ICD-10 criteria.\n- Age between 18 and 64 years old\n- European Portuguese as mother tongue\n- Score ≥ 16 on the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)\n- 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.\n- 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."}

Exclusion criteria

• {"criterion_text":"- Patients with a current or previous history of psychotic illness (schizophrenia, delusions, among others)\n- 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;\n- Patients with bipolar disorder\n- Patients with tic disorders\n- Patients with borderline personality disorder\n- Patients with social anxiety disorder\n- Patients with a current or previous history of eating disorder in the last 6 months\n- Patients with a history of neurological disease or traumatic brain injury\n- Patients with a history of alcohol or illicit substance abuse in the last 6 months\n- Patients who are experiencing or have experienced a major depressive episode in the last 6 months\n- Patients with contraindications to undergo MRI cannot participate in the assessment of the exploratory endpoint\n- Patients undergoing deep brain stimulation\n- Presence of sensory deficits that prevent participation in the clinical study\n- Pregnant or breastfeeding women\n- Patients who are undergoing or have undergone psychotherapy in the last 6 months\n- Patients taking medication or receiving prohibited treatments\n- Allergy to pramipexole and any of its excipients\n- Patients with creatinine clearance ≤ 50 ml/min (calculated using the Cockcroft-Gault formula)\n- Patients with NYHA III or IV heart failure or any other severe cardiovascular disease"}

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Change from baseline to week 16 in the total score of the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS), compared between randomized dose groups of pramipexole."}

Secondary endpoints

• {"endpoint_text":"- Number of adverse events observed (nonserious, serious not related to the investigational medicinal product, and serious related to the investigational medicinal product) from day 2 (V1; after the first dose of the investigational medicinal product) to the week 24 (V11; end of study) in the different pramipexole treatment groups.","definition_or_measurement_approach":"Count and classification of adverse events (non-serious, serious unrelated, serious related) occurring from day 2 after first dose until week 24, reported and compared across pramipexole dose groups."}

Portugal

Earliest CTIS Part Ii Submission Date

14-05-2024

Latest Decision Or Authorization Date

02-03-2026

Processing Time Days

657

Number Of Sites

1

Number Of Participants

48

Primary sponsor

Full Name

CCAB Centro Clinico Academico Braga Associacao

Organisation Type

Pharmaceutical company

Country Of Registered Address

Portugal

Third parties

• {"country":"","full_name":"Fundação Luso-Americana para o Desenvolvimento (FLAD)","duties_or_roles":"Source of monetary support","organisation_type":""}