Cannabidiol Treatment in Patients With Early Psychosis (CBD)

• ClinicalTrials.gov Identifier: NCT02504151
• Recruitment Status: Completed
• First Posted: July 21, 2015
• Results First Posted: September 6, 2022
• Last Update Posted: September 6, 2022
• 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)
• Actual Enrollment: 18 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
• Actual Study Start Date: January 28, 2016
• Actual Primary Completion Date: March 2, 2018
• Actual Study Completion Date: March 9, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Drug: Cannabidiol; Other Name: CBD; Drug: Placebo
Experimental: 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).	Drug: Cannabidiol; Other Name: CBD; Drug: Placebo

Outcome Measures

Primary Outcome Measures :

1. Positive and Negative Syndrome Scale (PANSS) Over Time [ Time Frame: Completed each time subject is seen over 10 weeks (screening, period 1 baseline, period 1 week 1, period 1 week 2, period 1 week 3, period 1 week 4, period 2 baseline, period 2 week 1, period 2 week 2, period 2 week 3, period 2 week 4) ]
   The Positive and Negative Syndrome Scale is a 30-item scale to assess both the positive and negative symptom symptoms of schizophrenia. The range total score is 30-210. An improvement in symptoms is reflected by a lower score.
2. Clinical Global Impression of Severity Scale Over Time [ Time Frame: Completed each time subject is seen over 10 weeks (screening, period 1 baseline, period 1 week 1, period 1 week 2, period 1 week 3, period 1 week 4, period 2 baseline, period 2 week 1, period 2 week 2, period 2 week 3, period 2 week 4) ]
   Clinical Global Impression of Severity Scale score is a global rating of improvement scale, which requires subjects to rate their degree of improvement on a 7-point scale. The total range score is 1-7. A reduction in scores indicates improvement.

Secondary Outcome Measures :

1. Patient Assessment of Own Functioning Inventory (PAOFI) Over Time [ Time Frame: Completed each time subject is seen over 10 weeks (screening, period 1 baseline, period 1 week 1, period 1 week 2, period 1 week 3, period 1 week 4, period 2 baseline, period 2 week 1, period 2 week 2, period 2 week 3, period 2 week 4) ]
   The PAOFI measures subjects' perceptions of functioning when performing everyday tasks and activities that reflect cognitive strengths and weaknesses. Subjects rate each item on a scale ranging from 0 (almost never) to 5 (almost always). The total score is the sum of the responses to each item (score of 0 to 160). High scores on the PAOFI subscales are indicative of poor perceived cognitive functioning. This scale was modified to remove 3 items- so the highest possible score is 145 for this outcome measure.
2. Quality of Life Scale (QLS) Over Time [ Time Frame: Completed each time subject is seen over 10 weeks (screening, period 1 baseline, period 1 week 1, period 1 week 2, period 1 week 3, period 1 week 4, period 2 baseline, period 2 week 1, period 2 week 2, period 2 week 3, period 2 week 4) ]
   The Quality of Life Scale (QLS) is a 21-item scale rated from a semi structured interview, each item is rated 0-6. The specific descriptors vary among items, but the high end of the scales (scores of 5 and 6) reflects normal or unimpaired functioning, and the low end of the scales (scores of 0 and 1) reflects severe impairment of the function in question. A highest score of 126 would indicate unimpaired functioning.

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

  Study Documents (Full-Text)

Documents provided by Mohini Ranganathan, Yale University:

Study Protocol and Statistical Analysis Plan  [PDF] May 17, 2017

More Information

• Responsible Party: Mohini Ranganathan, MD, Yale University
• ClinicalTrials.gov Identifier: NCT02504151
• Other Study ID Numbers: 1412015000
• First Posted: July 21, 2015
• Results First Posted: September 6, 2022
• Last Update Posted: September 6, 2022
• Last Verified: August 2022

Additional relevant MeSH terms:

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