Working… Menu

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. Identifier: NCT00588731
Recruitment Status : Completed
First Posted : January 9, 2008
Results First Posted : June 8, 2017
Last Update Posted : June 8, 2017
Stanley Medical Research Institute
Information provided by (Responsible Party):
Mohini Ranganathan, Yale University

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

Layout table for study information
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

Arm Intervention/treatment
Experimental: Cannabidiol Drug: Cannabidiol
Active Cannabidiol daily over 6 weeks

Placebo Comparator: Placebo Drug: Placebo

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.

Information from the National Library of Medicine

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.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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 identifier (NCT number): NCT00588731

Layout table for location information
United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Yale University
Stanley Medical Research Institute
Layout table for investigator information
Principal Investigator: Mohini Ranganathan, M.D. Yale University
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Mohini Ranganathan, Assistant Professor, Yale University Identifier: NCT00588731    
Other Study ID Numbers: 0710003164
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:
Layout table for MeSH terms
Psychotic Disorders
Cognitive Dysfunction
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Cognition Disorders
Neurocognitive Disorders