Cannabidiol Treatment of Cognitive Dysfunction in Schizophrenia

• 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: Yale University
• Collaborator: Stanley Medical Research Institute
• Information provided by (Responsible Party): Mohini Ranganathan, Yale University

Tracking Information

• First Submitted Date: December 29, 2007
• First Posted Date: 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: February 2009
• Actual Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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 (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 (submitted: January 8, 2008): 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: Cannabidiol Treatment of Cognitive Dysfunction in Schizophrenia
• Official Title: 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Schizophrenia
• Schizoaffective Disorder

Intervention

• 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 Jul;235(7):1923-1932. doi: 10.1007/s00213-018-4885-9. Epub 2018 Apr 5.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 6, 2017): 41
• Original Estimated Enrollment (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

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, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00588731
• Other Study ID Numbers: 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: Yale University
• Collaborators: Stanley Medical Research Institute

Investigators

• Principal Investigator: Mohini Ranganathan, M.D.; Yale University

• PRS Account: Yale University
• Verification Date: June 2017