Cannabidiol Treatment of Cognitive Dysfunction in Schizophrenia

Tracking Information
First Submitted Date ICMJE	December 29, 2007
First Posted Date ICMJE	January 9, 2008
Results First Submitted Date	August 4, 2016
Results First Posted Date	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; (submitted: June 6, 2017)	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.
Original Primary Outcome Measures ICMJE; (submitted: January 8, 2008)	Improvement in verbal short term memory [ Time Frame: 6 weeks ]
Change History	Complete list of historical versions of study NCT00588731 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: June 6, 2017)	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.
Original Secondary Outcome Measures ICMJE; (submitted: January 8, 2008)	Improvement in overall cognition as measured on the MATRICS Battery [ Time Frame: 6 weeks ]
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	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	Phase 2
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition ICMJE	Schizophrenia; Schizoaffective Disorder
Intervention ICMJE	Drug: Cannabidiol Active Cannabidiol daily over 6 weeks; Drug: Placebo Placebo
Study Arms	Experimental: Cannabidiol Intervention: Drug: Cannabidiol; Placebo Comparator: Placebo Intervention: Drug: Placebo
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 Apr 5. doi: 10.1007/s00213-018-4885-9. [Epub ahead of print]
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: June 6, 2017)	41
Original Estimated Enrollment ICMJE; (submitted: January 8, 2008)	38
Actual Study Completion Date	December 2013
Actual Primary Completion Date	December 2013 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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.
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 65 Years (Adult)
Accepts Healthy Volunteers	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
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Mohini Ranganathan, Yale University
Study Sponsor ICMJE	Yale University
Collaborators ICMJE	Stanley Medical Research Institute
Investigators ICMJE	Principal Investigator: Mohini Ranganathan, M.D. Yale University
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