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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
  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:


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 ]

Enrollment: 36
Study Start Date: February 2009
Study Completion Date: December 2013
Primary Completion Date: December 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00588731

Locations
United States, Connecticut
Yale University
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: April 1, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Cognition Disorders
Psychotic Disorders
Schizophrenia
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Cannabinoid Receptor Antagonists
Cannabinoid Receptor Modulators
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014