Cannabidiol Treatment in Patients With Early Psychosis (CBD)

• ClinicalTrials.gov Identifier: NCT02504151
• Recruitment Status: Active, not recruiting
• First Posted: July 21, 2015
• Last Update Posted: January 11, 2021
• Sponsor: Yale University
• Information provided by (Responsible Party): Mohini Ranganathan, Yale University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Schizophrenia; Schizoaffective Disorder	Drug: Cannabidiol; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 72 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Cannabidiol Treatment in Patients With Early Psychosis
• Study Start Date: August 2015
• Estimated Primary Completion Date: June 2021
• Estimated Study Completion Date: December 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Order 1; The subject will receive treatment with CBD for four weeks, followed by a two week washout period, followed by four weeks of placebo.	Drug: Cannabidiol; Drug: Placebo
Experimental: Order 2; The subject will receive placebo for four weeks, followed by a 2 week washout period, followed by four weeks of treatment with CBD.	Drug: Cannabidiol; Drug: Placebo

Outcome Measures

Primary Outcome Measures :

1. Positive and Negative Sydrome Scale [ Time Frame: Completed each time subject is seen over 10 weeks. ]
2. Clinical Global Impression of Severity scale [ Time Frame: Completed each time subject is seen over 10 weeks. ]

Secondary Outcome Measures :

1. Patient Assessment of Own Functioning Inventory [ Time Frame: Completed 10 times over 10 weeks. ]
2. Quality of Life Scale [ Time Frame: Completed 10 times over 10 weeks. ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Connecticut

Connecticut Mental Health Center

New Haven, Connecticut, United States, 06519

VA Connecticut Healthcare System

West Haven, Connecticut, United States, 06516

Sponsors and Collaborators

Yale University

More Information

• Responsible Party: Mohini Ranganathan, MD, Yale University
• ClinicalTrials.gov Identifier: NCT02504151
• Other Study ID Numbers: 1412015000
• First Posted: July 21, 2015
• Last Update Posted: January 11, 2021
• Last Verified: January 2021

Additional relevant MeSH terms:

Schizophrenia; Psychotic Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Epidiolex; Anticonvulsants