Cannabidiol Treatment in Patients With Early Psychosis

NCT02504151 | Completed Phase 2 Results DMC

• 1 other identifier: 1412015000
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (2)

• Positive and Negative Syndrome Scale (PANSS) Over Time

  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.

  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 Over Time

  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.

  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)

Secondary Outcomes (2)

• Patient Assessment of Own Functioning Inventory (PAOFI) Over Time

  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)

• Quality of Life Scale (QLS) Over Time

  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)

Study Arms (2)

Cannabidiol, then Placebo

EXPERIMENTAL

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; Drug: Placebo

Placebo, then Cannabidiol

EXPERIMENTAL

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; Drug: Placebo

Interventions

Cannabidiol DRUG

Also known as: CBD

Cannabidiol, then Placebo; Placebo, then Cannabidiol

Placebo DRUG

Cannabidiol, then Placebo; Placebo, then Cannabidiol

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female
• Primary psychotic disorder
• Ages 18-65 (inclusive)

You may not qualify if:

• Current significant medical condition or other comorbidities
• Current substance depdendence
• Women who are pregnant or breastfeeding

Sponsors & Collaborators

• Yale University: lead

Study Sites (2)

Connecticut Mental Health Center

New Haven, Connecticut, 06519, United States

Location

VA Connecticut Healthcare System

West Haven, Connecticut, 06516, United States

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Cannabidiol

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Dr. Mohini Ranganathan
• Organization: Yale

mohini.ranganathan@yale.edu

(203)932-5711

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 17, 2015
• First Posted: July 21, 2015
• Study Start: January 28, 2016
• Primary Completion: March 2, 2018
• Study Completion: March 9, 2018
• Last Updated: September 6, 2022
• Results First Posted: September 6, 2022

Record last verified: 2022-08

Locations

US (2)