Obsessive-compulsive disorder
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients of both sexes; aged between 18 and 65 years; diagnosed with obsessive-compulsive disorder; undergoing outpatient pharmacological treatment with selective serotonin reuptake inhibitors or clomipramine; with current symptoms of obsessions, compulsions or both; with severity assessed by the scale Y-BOCS (Yale-Brown Obsessive-Compulsive Scale) (score greater than or equal to 20 out of a total of 40 possible points).
Exclusion criteria
Exclusion criteria: Age under 18 and over 65 years; presence of relevant medical condition (cardiovascular diseases, severe arterial hypertension, renal failure, liver disease, hypothyroidism, hyponatremia, hypovitaminosis B12, previous intracranial hypertension, epilepsy, pregnancy, breastfeeding); history of neurological disease (including severe traumatic brain injury and excluding headache); previous use of cannabis in the last month or history of dependence on any other psychoactive substance; previous history of allergy or idiosyncratic reactions to cannabis sativa derivatives; psychotic symptoms; suicidal ideation; personality disorder or diagnosis of substance use disorder according to The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria. Patients with changes in their pharmacological regimen in the last 30 days will not be able to participate in the study. Patients using medications that modulate the glutamatergic system (topiramate, lamotrigine, memantine) and benzodiazepines will be excluded
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Decrease in the severity of obsessive and compulsive symptoms, measured by the Y-BOCS (Yale-Brown Obsessive Compulsive Scale) by at least 25%, considering the initial (pre-intervention) and post-intervention assessments | — |
Secondary
| Measure | Time frame |
|---|---|
| Level and severity of side effects associated with the use of cannabidiol: it is expected to find an absence of side effects, which will be assessed by the Ugvalg for Kliniske Undersgeiser – UKU scale | — |
Countries
Brazil
Contacts
Faculdade de Medicina de Ribeirão Preto - Universidade de São Paulo