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CBD: Cannabidiol Treatment in Patients With Early Psychosis

Sponsor
Yale University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02504151
Collaborator
(none)
72
Enrollment
2
Locations
2
Arms
88
Duration (Months)
36
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

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
Phase 2

Study Design

Study Type:
Interventional
Anticipated 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 :
Aug 1, 2015
Anticipated Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

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 [Completed each time subject is seen over 10 weeks.]

  2. Clinical Global Impression of Severity scale [Completed each time subject is seen over 10 weeks.]

Secondary Outcome Measures

  1. Patient Assessment of Own Functioning Inventory [Completed 10 times over 10 weeks.]

  2. Quality of Life Scale [Completed 10 times over 10 weeks.]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Site City State Country Postal Code
1 Connecticut Mental Health Center New Haven Connecticut United States 06519
2 VA Connecticut Healthcare System West Haven Connecticut United States 06516

Sponsors and Collaborators

  • Yale University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mohini Ranganathan, MD, Yale University
ClinicalTrials.gov Identifier:
NCT02504151
Other Study ID Numbers:
  • 1412015000
First Posted:
Jul 21, 2015
Last Update Posted:
Jan 21, 2022
Last Verified:
Jan 1, 2022
Additional relevant MeSH terms:
Schizophrenia
Psychotic Disorders
Cannabidiol

Study Results

No Results Posted as of Jan 21, 2022