Cannabidiol Treatment of Cognitive Dysfunction in Schizophrenia

This study has been completed.
Sponsor:
Collaborator:
Stanley Medical Research Institute
Information provided by (Responsible Party):
Mohini Ranganathan, Yale University
ClinicalTrials.gov Identifier:
NCT00588731
First received: December 29, 2007
Last updated: April 1, 2014
Last verified: April 2014

December 29, 2007
April 1, 2014
February 2009
December 2013   (final data collection date for primary outcome measure)
Verbal short term memory [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Improvement in verbal short term memory [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Improvement in overall cognition as measured on the MATRICS Battery [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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
36
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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00588731
0710003164, 07TGS-1082
No
Mohini Ranganathan, Yale University
Yale University
Stanley Medical Research Institute
Principal Investigator: Mohini Ranganathan Yale University
Yale University
April 2014

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