Safety and Efficacy of Pramipexole Treatment in Resistant Obsessive-Compulsive Disorder (OCD): Pilot, Randomized and Controlled Clinical Trial

Phase 1

• Conditions: Obsessive-compulsive disorder (OCD); MedDRA version: 20.0Level: LLTClassification code: 10030029Term: OCD Class: 10037175; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: CTIS2024-511085-37-00
• Lead Sponsor: CCAB Centro Clinico Academico Braga Associacao

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-04
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

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.

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified