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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

Tracking Information
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
 (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 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
Condition  ICMJE
  • Schizophrenia
  • Schizoaffective Disorder
Intervention  ICMJE
  • Drug: Cannabidiol
    Active Cannabidiol daily over 6 weeks
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • 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.

*   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  ICMJE 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  ICMJE
Sexes Eligible for Study: All
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
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
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