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Cannabidiol Treatment of Cognitive Dysfunction in Schizophrenia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00588731
First Posted: January 9, 2008
Last Update Posted: June 8, 2017
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.
Collaborator:
Stanley Medical Research Institute
Information provided by (Responsible Party):
Mohini Ranganathan, Yale University
December 29, 2007
January 9, 2008
August 4, 2016
June 8, 2017
June 8, 2017
February 2009
December 2013   (Final data collection date for primary outcome measure)
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.
Improvement in verbal short term memory [ Time Frame: 6 weeks ]
Complete list of historical versions of study NCT00588731 on ClinicalTrials.gov Archive Site
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.
Improvement in overall cognition as measured on the MATRICS Battery [ Time Frame: 6 weeks ]
Not Provided
Not Provided
 
Cannabidiol Treatment of Cognitive Dysfunction in Schizophrenia
Cannabinoid Receptor Antagonist Treatment of Cognitive Dysfunction in Schizophrenia
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Schizophrenia
  • Schizoaffective Disorder
  • Drug: Cannabidiol
    Active Cannabidiol daily over 6 weeks
  • Drug: Placebo
    Placebo
  • Experimental: Cannabidiol
    Intervention: Drug: Cannabidiol
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
41
December 2013
December 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00588731
0710003164
07TGS-1082
No
Not Provided
Not Provided
Mohini Ranganathan, Yale University
Yale University
Stanley Medical Research Institute
Principal Investigator: Mohini Ranganathan, M.D. Yale University
Yale University
June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP