Cannabidiol Treatment in Patients With Early Psychosis (CBD)

Yale University

Status and phase: Completed; Phase 2

Conditions: Schizophrenia; Schizoaffective Disorder

Treatments: Drug: Placebo; Drug: Cannabidiol

Study type: Interventional

Funder types: Other

Identifiers

NCT02504151

1412015000

Details and patient eligibility

About

Cannabidiol (CBD) is a component of herbal cannabis that is present in varying concentrations in cannabis extracts. CBD has been shown to produce central effects including hypnotic, anticonvulsive, anxiolytic and neuroprotective effects.The investigators hypothesize that treatment with CBD will result in: 1) Improvement evidenced by a reduction in scores on the Positive and Negative Syndrome Scale for Schizophrenia (PANSS), 2) Improvement evidenced by a reduction in the Clinical Global Impression of Severity scale (CGI); Secondary Hypothesis: 1) Greater improvement in functioning as measured on the "Patient Assessment of Own Functioning Inventory: (PAOFI) and the Quality of Life Scale (QLS) In this 2 period cross over design, subjects will be randomized in a 1:1 ratio to receive either: Order 1: CBD (Period 1) followed by placebo (Period 2) or Order 2: Placebo (Period 1) followed by CBD (Period 2) under double-blind conditions. The 2 study periods will be separated by a washout of at least 2 weeks. During each period subjects will receive study medications (CBD [total 800mg/day] or placebo) for a period of 4 weeks.

Enrollment: 18 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female
• Primary psychotic disorder
• Ages 18-65 (inclusive)

Exclusion criteria

• Current significant medical condition or other comorbidities
• Current substance depdendence
• Women who are pregnant or breastfeeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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18 participants in 2 patient groups

Cannabidiol, then Placebo

Experimental group

Description:

The subject will receive treatment with cannabidiol (CBD)(800mg/day) for four weeks, followed by a two week washout period, followed by four weeks of placebo.

Treatment:

Drug: Cannabidiol

Drug: Placebo

Placebo, then Cannabidiol

Experimental group

Description:

The subject will receive placebo for four weeks, followed by a two week washout period, followed by four weeks of treatment with cannabidiol (CBD)(800mg/day).

Treatment:

Drug: Cannabidiol

Drug: Placebo