Cannabidiol Treatment in Patients With Early Psychosis (CBD)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02504151 |
Recruitment Status :
Completed
First Posted : July 21, 2015
Results First Posted : September 6, 2022
Last Update Posted : September 6, 2022
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Schizophrenia Schizoaffective Disorder | Drug: Cannabidiol Drug: Placebo | Phase 2 |
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 |

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 |
- 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.
- 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.
- 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.
- 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
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

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
United States, Connecticut | |
Connecticut Mental Health Center | |
New Haven, Connecticut, United States, 06519 | |
VA Connecticut Healthcare System | |
West Haven, Connecticut, United States, 06516 |
Documents provided by Mohini Ranganathan, Yale University:
Responsible Party: | Mohini Ranganathan, MD, Yale University |
ClinicalTrials.gov Identifier: | NCT02504151 |
Other Study ID Numbers: |
1412015000 |
First Posted: | July 21, 2015 Key Record Dates |
Results First Posted: | September 6, 2022 |
Last Update Posted: | September 6, 2022 |
Last Verified: | August 2022 |
Schizophrenia Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders |
Mental Disorders Cannabidiol Anticonvulsants |