Cannabidiol Treatment in Patients With Early Psychosis

Schizophrenia Clinical Trial

— CBD  

Official title:

Cannabidiol Treatment in Patients With Early Psychosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02504151
• Other study ID #: 1412015000
• Status: Completed
• Phase: Phase 2
• Start date: January 28, 2016
• Est. completion date: March 9, 2018

Study information

• Verified date: August 2022
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: March 9, 2018
• Est. primary completion date: March 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Drug:
• Cannabidiol

• Placebo

Locations

Country	Name	City	State
United States	Connecticut Mental Health Center	New Haven	Connecticut
United States	VA Connecticut Healthcare System	West Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Patient Assessment of Own Functioning Inventory (PAOFI) Over Time	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.	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	Quality of Life Scale (QLS) Over Time	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.	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)