Initial study of the effects of cannabidiol in patients with generalized anxiety compared to the effects of an anxiolytic (clonazepan)

Phase 4

• Conditions: ervous system disease; generalized anxiety; F41.1; Mental and behavioral disorders

• Registration Number: RBR-2fw8kg
• Lead Sponsor: Faculdade de Medicina de Ribeirão Preto - USP

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-08-07
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Diagnosis of Generalized Anxiety Disorder (from SCID-5-CV); both sexes, education above eight years; age between 18 and 60 years; total score greater than or equal to 20 on the Hamilton Rating Scale for Anxiety (HAMA); total score greater than or equal to the Global Clinical Impression - Severity scale (CGI-S); total score greater than or equal to 17 on the Hamilton Depression Rating Scale (HAMD17).

Exclusion Criteria

Presence of general medical condition; history of neurological disease (except headache); current or past diagnosis of psychoactive substance abuse or use in the past three months; psychotic conditions of any nature according to SCID-5_CV throughout life; other psychiatric diagnoses in addition to generalized anxiety disorder in the last 6 months (except for past remitted depression, social phobia and / or specific phobias); suicide risk (including suicide attempt in the last 1 year); history of previous drug treatment for generalized anxiety disorder; hx of allergy or idiosyncratic reactions to Cannabis sativa derivatives.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Expected outcome 1 - decrease in symptoms of anxiety assessed using the Hamilton Anxiety Rating Scale (HAMA) and Generalized Anxiety Disorder Questionnaire (GAD7)

Secondary Outcome Measures

Name	Time	Method
Secondary outcome 1 - level of side effects, assessed using the Psychotropic Side Effects Scale of the Clinical Research Committee of the Scandinavian Society for Psychopharmacology (UKU) and the Epworth Sleepiness Scale;Secondary outcome 2 - level of concern, assessed using the Pennsylvania State Concern Questionnaire (PSWQ);Secondary outcome 3 - decrease in facial emotion recognition bias, assessed through a computerized online task, consisting of 24 photo stimuli of actors, strangers, of both sexes, representing expressions of six basic emotions (joy, sadness, fear, disgust, anger and surprise), which must be recognized by the participants.