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Cannabidiol Treatment in Patients With Early Psychosis (CBD)

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ClinicalTrials.gov Identifier: NCT02504151
Recruitment Status : Active, not recruiting
First Posted : July 21, 2015
Last Update Posted : July 27, 2020
Sponsor:
Information provided by (Responsible Party):
Mohini Ranganathan, Yale University

Study Description
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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
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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 : December 2020
Estimated Study Completion Date : December 2020

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Arms and Interventions
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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
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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
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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02504151


Locations
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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
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Responsible Party: Mohini Ranganathan, MD, Yale University
ClinicalTrials.gov Identifier: NCT02504151    
Other Study ID Numbers: 1412015000
First Posted: July 21, 2015    Key Record Dates
Last Update Posted: July 27, 2020
Last Verified: July 2020
Additional relevant MeSH terms:
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Schizophrenia
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
 Mental Disorders
Epidiolex
Anticonvulsants