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
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Sponsor:
Yale University
Collaborator:
Stanley Medical Research Institute
Information provided by (Responsible Party):
Mohini Ranganathan, Yale University
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Tracking Information | ||||
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First Submitted Date ICMJE | December 29, 2007 | |||
First Posted Date ICMJE | January 9, 2008 | |||
Results First Submitted Date ICMJE | August 4, 2016 | |||
Results First Posted Date ICMJE | June 8, 2017 | |||
Last Update Posted Date | June 8, 2017 | |||
Study Start Date ICMJE | February 2009 | |||
Actual Primary Completion Date | December 2013 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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.
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Original Primary Outcome Measures ICMJE |
Improvement in verbal short term memory [ Time Frame: 6 weeks ] | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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.
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Original Secondary Outcome Measures ICMJE |
Improvement in overall cognition as measured on the MATRICS Battery [ Time Frame: 6 weeks ] | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Cannabidiol Treatment of Cognitive Dysfunction in Schizophrenia | |||
Official Title ICMJE | Cannabinoid Receptor Antagonist Treatment of Cognitive Dysfunction in Schizophrenia | |||
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. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Boggs DL, Surti T, Gupta A, Gupta S, Niciu M, Pittman B, Schnakenberg Martin AM, Thurnauer H, Davies A, D'Souza DC, Ranganathan M. The effects of cannabidiol (CBD) on cognition and symptoms in outpatients with chronic schizophrenia a randomized placebo controlled trial. Psychopharmacology (Berl). 2018 Jul;235(7):1923-1932. doi: 10.1007/s00213-018-4885-9. Epub 2018 Apr 5. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
41 | |||
Original Estimated Enrollment ICMJE |
38 | |||
Actual Study Completion Date ICMJE | December 2013 | |||
Actual Primary Completion Date | December 2013 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00588731 | |||
Other Study ID Numbers ICMJE | 0710003164 07TGS-1082 |
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Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Mohini Ranganathan, Yale University | |||
Study Sponsor ICMJE | Yale University | |||
Collaborators ICMJE | Stanley Medical Research Institute | |||
Investigators ICMJE |
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PRS Account | Yale University | |||
Verification Date | June 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |