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Cannabidiol Treatment of Cognitive Dysfunction in Schizophrenia
This study is not yet open for participant recruitment.
Verified by Yale University, January 2009
First Received: December 29, 2007   Last Updated: January 7, 2009   History of Changes
Sponsors and Collaborators: Yale University
Stanley Medical Research Institute
Information provided by: Yale University
ClinicalTrials.gov Identifier: NCT00588731
  Purpose

This study is a six-week, randomized, placebo-controlled, parallel group, fixed dose trial comparing cannabidiol Vs. placebo added to a stable dose of olanzapine or risperidone in patients diagnosed with schizophrenia. We hypothesize that adjunctive CBD treatment in antipsychotic-treated schizophrenia patients will result in an improvement in verbal short term memory as measured by increase in total immediate recall score on the HVLT.


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

MedlinePlus related topics: Memory Schizophrenia
Drug Information available for: Cannabidiol
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title: Cannabinoid Receptor Antagonist Treatment of Cognitive Dysfunction in Schizophrenia

Further study details as provided by Yale University:

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

Secondary Outcome Measures:
  • Improvement in 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: July 2011
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Cannabidiol: Experimental Drug: Cannabidiol
Cannabidiol 800mg per day X 6 weeks
Placebo: Placebo Comparator Drug: Placebo
Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Schizophrenia or Schizoaffective disorder (DSM-IV SCID-confirmed),
  2. Age: 18-55 years
  3. Capable of providing informed consent
  4. HVLT total immediate recall scores lower (≥ 1 SD) from the mean score in the general population (28.16±1.58) [40] .
  5. At least 3 months of treatment with stable doses (no dose change in 4 weeks) olanzapine (10-20 mg) or risperidone (3-6 mg) or long acting Risperidone

Exclusion Criteria:

  1. Other current or past DSM-IV Axis I diagnoses that require pharmacological treatment; At the discretion of the investigator, some diagnoses e.g., past adjustment disorders may be permitted.
  2. DSM-IV/DSM-IV-TR diagnosis of alcohol or substance abuse (other than nicotine) within the last 3 months or a DSM-IV/DSM-IV-TR diagnosis of alcohol or substance dependence (other than nicotine) within the last 6 months.
  3. Serious medical or neurological illness (unstable cardiac disease, AIDS, malignancy, liver or renal impairment, dementia) or treatment for a medical disorder that could interfere with study participation.
  4. History of significant head injury/trauma.
  5. Women who are pregnant, nursing or unwilling to use appropriate birth control measures during study participation. This is because the effects of CBD on a fetus are unknown
  6. Inability to complete neuropsychological tests.
  7. Current treatment with quetiapine, ziprasidone, aripiprazole, clozapine or typical antipsychotics (at antipsychotic doses)
  8. Current treatment with investigational agents or participation in another clinical trial
  9. Current participation in a weight loss program
  10. Current treatment with a cognition enhancer
  11. Treatment with ECT within the past 2 months
  12. Patients on concomitant anticholinergic drugs or benzodiazepines will be required to withhold the dose 4 hours prior to cognitive testing.
  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
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: Yale University ( Mohini Ranganathan, MD )
Study ID Numbers: 0710003164, 07TGS-1082
Study First Received: December 29, 2007
Last Updated: January 7, 2009
ClinicalTrials.gov Identifier: NCT00588731     History of Changes
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Schizophrenia
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on May 07, 2009