Cannabidiol Treatment of Cognitive Dysfunction in Schizophrenia
![]() |
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: NCT00588731 |
Recruitment Status :
Completed
First Posted : January 9, 2008
Results First Posted : June 8, 2017
Last Update Posted : June 8, 2017
|
Sponsor:
Yale University
Collaborator:
Stanley Medical Research Institute
Information provided by (Responsible Party):
Mohini Ranganathan, Yale University
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Study Type | Interventional |
---|---|
Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Conditions |
Schizophrenia Schizoaffective Disorder |
Interventions |
Drug: Cannabidiol Drug: Placebo |
Enrollment | 41 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Cannabidiol | Placebo |
---|---|---|
![]() |
Cannabidiol: Active Cannabidiol daily over 6 weeks | Placebo: Placebo |
Period Title: Overall Study | ||
Started | 21 | 20 |
Completed | 18 | 18 |
Not Completed | 3 | 2 |
Reason Not Completed | ||
Withdrawal by Subject | 3 | 2 |
Baseline Characteristics
Arm/Group Title | Cannabidiol | Placebo | Total | |
---|---|---|---|---|
![]() |
Cannabidiol: Active Cannabidiol daily over 6 weeks | Placebo: Placebo | Total of all reporting groups | |
Overall Number of Baseline Participants | 18 | 18 | 36 | |
![]() |
A total of 36 participants completed all aspects of the study. Higher T-scores represent better outcomes.
|
|||
Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
||||
Number Analyzed | 18 participants | 18 participants | 36 participants | |
48.4 (9.3) | 46.4 (9.5) | 47.4 (9.3) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
||||
Number Analyzed | 18 participants | 18 participants | 36 participants | |
Female |
6 33.3%
|
5 27.8%
|
11 30.6%
|
|
Male |
12 66.7%
|
13 72.2%
|
25 69.4%
|
|
Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
||||
Number Analyzed | 18 participants | 18 participants | 36 participants | |
American Indian or Alaska Native |
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Asian |
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Native Hawaiian or Other Pacific Islander |
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Black or African American |
7 38.9%
|
12 66.7%
|
19 52.8%
|
|
White |
10 55.6%
|
5 27.8%
|
15 41.7%
|
|
More than one race |
1 5.6%
|
1 5.6%
|
2 5.6%
|
|
Unknown or Not Reported |
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Region of Enrollment
Measure Type: Number Unit of measure: Participants |
||||
United States | Number Analyzed | 18 participants | 18 participants | 36 participants |
18 | 18 | 36 | ||
Length of Diagnosis
Mean (Standard Deviation) Unit of measure: Years |
||||
Number Analyzed | 18 participants | 18 participants | 36 participants | |
25.6 (12.7) | 28.2 (8.5) | 26.9 (10.6) | ||
Intelligence Quotient (IQ)
Mean (Standard Deviation) Unit of measure: IQ |
||||
Number Analyzed | 18 participants | 18 participants | 36 participants | |
91.6 (18.4) | 82.3 (15.4) | 86.6 (17.3) | ||
Education
Mean (Standard Deviation) Unit of measure: Years |
||||
Number Analyzed | 18 participants | 18 participants | 36 participants | |
13.2 (1.6) | 12.8 (2) | 13 (1.8) | ||
Smoking Status
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 18 participants | 18 participants | 36 participants |
Smokers | 9 | 10 | 19 | |
Non-Smokers | 9 | 8 | 17 | |
Hopkins Verbal Learning Test T-Score
[1] Mean (Standard Deviation) Unit of measure: T-Score |
||||
Number Analyzed | 18 participants | 18 participants | 36 participants | |
32.5 (6.3) | 34.5 (6) | 33.5 (6.15) | ||
[1]
Measure Description: The Hopkins Verbal Learning Test is a measure of verbal short term memory. Each trial has a max total score of 12 (range of 0-12), and the max total score for all three trials is 36 (range of 0-36). The data listed is reported in the form of a t-score, with a higher score representing better verbal learning. These t-score values are normalizing the scores to populations, comparing them to a representative sample.
|
||||
Positive And Negative Syndrome Scale
[1] Mean (Standard Deviation) Unit of measure: T-score |
Number Analyzed | 18 participants | 18 participants | 36 participants |
PANSS Total Score | 76.6 (17) | 82.7 (8.8) | 79.65 (12.9) | |
PANSS Positive Subscale | 18.8 (4.7) | 20.6 (3.8) | 19.7 (4.25) | |
PANSS Negative Subscale | 20.7 (4.6) | 20.9 (4.7) | 20.8 (4.65) | |
PANSS General Subscale | 37.1 (10.3) | 41.2 (5.6) | 39.15 (7.95) | |
[1]
Measure Description: The PANSS is a scale used for measuring symptoms severity of patients with schizophrenia. Of the 30 items included: 7 constitute a Positive Scale, 7 a Negative Scale, and 16 a General Psychopathology Scale. The scores for these scales are arrived at by summation of ratings across component items (each item scored between 1-7). Therefore, the potential ranges are 7-49 for the Positive and Negative Scales, and 16-112 for the General Psychopathology Scale. The PANSS Total Score is the summation of these subscales and can range from a score of 30-210. A higher score indicates more severe symptoms.
|
||||
Medications
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 18 participants | 18 participants | 36 participants |
First Generation Antipsychotics | 9 | 5 | 14 | |
Second Generation Antipsychotics | 10 | 13 | 23 | |
Multiple Antipsychotics | 2 | 7 | 9 | |
Long Acting Injectable Antipsychotics | 3 | 6 | 9 | |
Antidepressant | 3 | 4 | 7 | |
Anticholinergic | 7 | 7 | 14 | |
Anticonvulsants/Mood Stabilizers | 3 | 6 | 9 | |
Benzodiazepine | 2 | 3 | 5 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Mohini Ranganathan, M.D. |
Organization: | Yale University |
Phone: | 203-932-5711 ext 2546 |
EMail: | mohini.ranganathan@yale.edu |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Mohini Ranganathan, Yale University |
ClinicalTrials.gov Identifier: | NCT00588731 |
Other Study ID Numbers: |
0710003164 07TGS-1082 |
First Submitted: | December 29, 2007 |
First Posted: | January 9, 2008 |
Results First Submitted: | August 4, 2016 |
Results First Posted: | June 8, 2017 |
Last Update Posted: | June 8, 2017 |