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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 Description
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Brief Summary:
This study is a six-week, randomized, placebo-controlled, fixed dose trial comparing cannabidiol Vs. placebo added to a stable dose of antipsychotic medications in patients diagnosed with schizophrenia.

Condition or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Disorder Drug: Cannabidiol Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cannabinoid Receptor Antagonist Treatment of Cognitive Dysfunction in Schizophrenia
Study Start Date : February 2009
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Cannabidiol

Arms and Interventions
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Arm Intervention/treatment
Experimental: Cannabidiol Drug: Cannabidiol
Active Cannabidiol daily over 6 weeks
Placebo Comparator: Placebo Drug: Placebo
Placebo


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


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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Schizophrenia or Schizoaffective disorder (DSM-IV SCID-confirmed),

Exclusion Criteria:

  • Women who are pregnant, nursing or unwilling to use appropriate birth control measures during study participation.
Contacts and Locations
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Information from the National Library of Medicine

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): NCT00588731


Locations
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United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Yale University
Stanley Medical Research Institute
Investigators
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Principal Investigator: Mohini Ranganathan, M.D. Yale University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Mohini Ranganathan, Assistant Professor, Yale University
ClinicalTrials.gov Identifier: NCT00588731    
Other Study ID Numbers: 0710003164
07TGS-1082
First Posted: January 9, 2008    Key Record Dates
Results First Posted: June 8, 2017
Last Update Posted: June 8, 2017
Last Verified: June 2017
Additional relevant MeSH terms:
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Schizophrenia
Psychotic Disorders
Cognitive Dysfunction
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
 Cognition Disorders
Neurocognitive Disorders
Epidiolex
Anticonvulsants