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Cannabidiol Treatment of Cognitive Dysfunction in Schizophrenia

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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:
Collaborator:
Stanley Medical Research Institute
Information provided by (Responsible Party):
Mohini Ranganathan, Yale University

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
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cannabidiol Placebo
Hide Arm/Group Description 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
Arm/Group Title Cannabidiol Placebo Total
Hide Arm/Group Description Cannabidiol: Active Cannabidiol daily over 6 weeks Placebo: Placebo Total of all reporting groups
Overall Number of Baseline Participants 18 18 36
Hide Baseline Analysis Population Description
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
1.Primary Outcome
Title Verbal Short Term Memory
Hide Description Verbal short term memory is measured through the Hopkins Verbal Learning Test. 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). However, the data listed below 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, with a mean of 50.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cannabidiol Placebo
Hide Arm/Group Description:
Cannabidiol: Active Cannabidiol daily over 6 weeks
Placebo: Placebo
Overall Number of Participants Analyzed 18 18
Mean (Standard Deviation)
Unit of Measure: t-score
Baseline 43.7  (9.7) 37.9  (7.4)
Endpoint 43.6  (10.8) 40.8  (8.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cannabidiol, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.90
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
2.Secondary Outcome
Title Overall Cognition as Measured on the MATRICS Battery
Hide Description Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) is intended to provide a relatively brief evaluation of key cognitive domains relevant to schizophrenia and related disorders. A higher score indicates better cognition (i.e. speed of processing, attention, verbal and non-verbal working memory, visual learning, reasoning, problem solving, and social cognition). The below scores are t-score values, which are normalized scores to the population and comparing the scores to a representative sample.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cannabidiol Placebo
Hide Arm/Group Description:
Cannabidiol: Active Cannabidiol daily over 6 weeks
Placebo: Placebo
Overall Number of Participants Analyzed 18 18
Mean (Standard Deviation)
Unit of Measure: t-score
Baseline 27.8  (14) 23.2  (13.3)
Endpoint 26.4  (12.2) 25.4  (12.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cannabidiol, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.76
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cannabidiol Placebo
Hide Arm/Group Description Cannabidiol: Active Cannabidiol daily over 6 weeks Placebo: Placebo
All-Cause Mortality
Cannabidiol Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cannabidiol Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/20 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cannabidiol Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   15/21 (71.43%)   17/20 (85.00%) 
Endocrine disorders     
Endocrine   1/21 (4.76%)  1/20 (5.00%) 
Eye disorders     
Photosensitivity   0/21 (0.00%)  1/20 (5.00%) 
Gastrointestinal disorders     
Dry Mouth   3/21 (14.29%)  2/20 (10.00%) 
Gastrointestinal   6/21 (28.57%)  10/20 (50.00%) 
Salivation   0/21 (0.00%)  1/20 (5.00%) 
Taste   0/21 (0.00%)  1/20 (5.00%) 
Infections and infestations     
Infection   4/21 (19.05%)  4/20 (20.00%) 
Metabolism and nutrition disorders     
Appetite Changes   1/21 (4.76%)  1/20 (5.00%) 
Weight Change   0/21 (0.00%)  1/20 (5.00%) 
Nervous system disorders     
Dizziness   1/21 (4.76%)  4/20 (20.00%) 
Extrapyramidal Side Effects   1/21 (4.76%)  0/20 (0.00%) 
Pain   7/21 (33.33%)  7/20 (35.00%) 
Sedation   4/21 (19.05%)  1/20 (5.00%) 
Sleep   2/21 (9.52%)  5/20 (25.00%) 
Psychiatric disorders     
Anxiety   1/21 (4.76%)  1/20 (5.00%) 
Abnormal Dreams   1/21 (4.76%)  2/20 (10.00%) 
Feeling "High"   1/21 (4.76%)  0/20 (0.00%) 
Tension   0/21 (0.00%)  1/20 (5.00%) 
Visual Changes   0/21 (0.00%)  1/20 (5.00%) 
Reproductive system and breast disorders     
Sexual Side Effects   1/21 (4.76%)  2/20 (10.00%) 
Skin and subcutaneous tissue disorders     
Rash   1/21 (4.76%)  0/20 (0.00%) 
Social circumstances     
Social Stress   0/21 (0.00%)  1/20 (5.00%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Mohini Ranganathan, M.D.
Organization: Yale University
Phone: 203-932-5711 ext 2546
EMail: mohini.ranganathan@yale.edu
Layout table for additonal information
Responsible Party: Mohini Ranganathan, Yale University
ClinicalTrials.gov Identifier: NCT00588731     History of Changes
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