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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:
Information provided by (Responsible Party):

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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Cannabidiol Cannabidiol: Active Cannabidiol daily over 6 weeks
Placebo Placebo: Placebo

Participant Flow:   Overall Study
    Cannabidiol   Placebo
STARTED   21   20 
COMPLETED   18   18 
NOT COMPLETED   3   2 
Withdrawal by Subject                3                2 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
A total of 36 participants completed all aspects of the study. Higher T-scores represent better outcomes.

Reporting Groups
  Description
Cannabidiol Cannabidiol: Active Cannabidiol daily over 6 weeks
Placebo Placebo: Placebo
Total Total of all reporting groups

Baseline Measures
   Cannabidiol   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 18   18   36 
Age 
[Units: Years]
Mean (Standard Deviation)
 48.4  (9.3)   46.4  (9.5)   47.4  (9.3) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      6  33.3%      5  27.8%      11  30.6% 
Male      12  66.7%      13  72.2%      25  69.4% 
Race (NIH/OMB) 
[Units: Participants]
Count of 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 
[Units: Participants]
     
United States   18   18   36 
Length of Diagnosis 
[Units: Years]
Mean (Standard Deviation)
 25.6  (12.7)   28.2  (8.5)   26.9  (10.6) 
Intelligence Quotient (IQ) 
[Units: IQ]
Mean (Standard Deviation)
 91.6  (18.4)   82.3  (15.4)   86.6  (17.3) 
Education 
[Units: Years]
Mean (Standard Deviation)
 13.2  (1.6)   12.8  (2)   13  (1.8) 
Smoking Status 
[Units: Participants]
     
Smokers   9   10   19 
Non-Smokers   9   8   17 
Hopkins Verbal Learning Test T-Score [1] 
[Units: T-Score]
Mean (Standard Deviation)
 32.5  (6.3)   34.5  (6)   33.5  (6.15) 
[1] 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] 
[Units: T-score]
Mean (Standard Deviation)
     
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] 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 
[Units: 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

1.  Primary:   Verbal Short Term Memory   [ Time Frame: 6 weeks ]

2.  Secondary:   Overall Cognition as Measured on the MATRICS Battery   [ Time Frame: 6 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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:  
Name/Title: Mohini Ranganathan, M.D.
Organization: Yale University
phone: 203-932-5711 ext 2546
e-mail: mohini.ranganathan@yale.edu



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