Expired Study
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New Haven, Connecticut 06511


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.


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.


Study is Available At:


Original ID:

0710003164


NCT ID:

NCT00588731


Secondary ID:

07TGS-1082


Study Acronym:


Brief Title:

Cannabidiol Treatment of Cognitive Dysfunction in Schizophrenia


Official Title:

Cannabinoid Receptor Antagonist Treatment of Cognitive Dysfunction in Schizophrenia


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

65 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Yale University


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

41


Enrollment Type:

Actual


Overall Contact Information

Official Name:Mohini Ranganathan, M.D.
Principal Investigator
Yale University

Study Dates

Start Date:February 2009
Completion Date:December 2013
Completion Type:Actual
Primary Completion Date:December 2013
Primary Completion Type:Actual
Verification Date:June 2017
Last Changed Date:June 6, 2017
First Received Date:December 29, 2007
First Results Date:August 4, 2016

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Overall Cognition as Measured on the MATRICS Battery
Time Frame:6 weeks
Safety Issues:False
Description: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 s
Outcome Type:Primary Outcome
Measure:Verbal Short Term Memory
Time Frame:6 weeks
Safety Issues:False
Description: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 fo

Study Interventions

Intervention Type:Drug
Name:Cannabidiol
Description:Active Cannabidiol daily over 6 weeks
Arm Name:Cannabidiol
Intervention Type:Drug
Name:Placebo
Description:Placebo
Arm Name:Placebo

Study Arms

Study Arm Type:Experimental
Arm Name:Cannabidiol
Study Arm Type:Placebo Comparator
Arm Name:Placebo

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Yale University
Agency Class:Other
Agency Type:Collaborator
Agency Name:Stanley Medical Research Institute

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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