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Cannabidiol Treatment of Cognitive Dysfunction in Schizophrenia

This study is currently recruiting participants.
Verified July 2012 by Yale University
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: July 17, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Schizoaffective Disorder
 Drug: Cannabidiol
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cannabinoid Receptor Antagonist Treatment of Cognitive Dysfunction in Schizophrenia

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Further study details as provided by Yale University:

Primary Outcome Measures:
  • Verbal short term memory [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall cognition as measured on the MATRICS Battery [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 38
Study Start Date: February 2009
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cannabidiol Drug: Cannabidiol
Active Cannabidiol daily over 6 weeks
Placebo Comparator: Placebo Drug: Placebo
Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00588731

Contacts
Contact: Ashley M Schnakenberg, B.S. 203-932-5711 ext 4485 ashley.schnakenberg@yale.edu

Locations
United States, Connecticut
Yale University Recruiting
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Yale University
Stanley Medical Research Institute
Investigators
Principal Investigator: Mohini Ranganathan Yale University
  More Information

No publications provided

Responsible Party: Mohini Ranganathan, Assistant Professor, Yale University
ClinicalTrials.gov Identifier: NCT00588731     History of Changes
Other Study ID Numbers: 0710003164, 07TGS-1082
Study First Received: December 29, 2007
Last Updated: July 17, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia
Cognition Disorders
 Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders

ClinicalTrials.gov processed this record on October 17, 2012