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Effects of Inclusion of Cannabidiol in the Usual Treatment of Obsessive Compulsive Disorder

Clinical effects of the addition of cannabidiol to the usual treatment of patients with diagnosis of Obsessive Compulsive Disorder

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
REBEC
Registry ID
RBR-467ksmb
Enrollment
Unknown
Registered
2023-03-29
Start date
2021-01-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obsessive-compulsive disorder

Interventions

Experimental group: 30 patients diagnosed with Obsessive Compulsive Disorder undergoing outpatient treatment, using Selective Serotonin Reuptake Inhibitors or clomipramine, maintaining symptoms of obs

Sponsors

Faculdade de Medicina de Ribeirão Preto - Universidade de São Paulo
Lead Sponsor
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto - Universidade de São Paulo
Collaborator

Eligibility

Age
18 Years to 65 Years

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

MeasureTime 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

MeasureTime 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

Public ContactJosé Alexandre Crippa

Faculdade de Medicina de Ribeirão Preto - Universidade de São Paulo

jcrippa@fmrp.usp.br+55 16 36022703

Outcome results

None listed

Source: REBEC (via WHO ICTRP)