Cannabidiol Treatment in Patients With Early Psychosis

NCT ID: NCT02504151

Last Updated: 2022-09-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-28
• Study Completion Date: 2018-03-09

Brief Summary

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.

Conditions

Schizophrenia; Schizoaffective Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Cannabidiol, then Placebo

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.

Group Type: EXPERIMENTAL

Cannabidiol

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Placebo, then Cannabidiol

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).

Group Type: EXPERIMENTAL

Cannabidiol

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Interventions

Cannabidiol

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Other Intervention Names

CBD

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Mohini Ranganathan

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Connecticut Mental Health Center

New Haven, Connecticut, United States

VA Connecticut Healthcare System

West Haven, Connecticut, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1412015000

Identifier Type: -

Identifier Source: org_study_id