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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: June 6, 2017
Last verified: June 2017
  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
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, 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 Mohini Ranganathan, Yale University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 41
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   (Adult)
Sexes Eligible for Study:   All
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, M.D. Yale University
  More Information

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
Results First Received: August 4, 2016
Last Updated: June 6, 2017

Additional relevant MeSH terms:
Schizophrenia
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Cannabinoid Receptor Antagonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 26, 2017