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

History of Changes

Tracking Information

First Received Date ^ICMJE

December 29, 2007

Last Updated Date

June 6, 2017

Start Date ^ICMJE

February 2009

Primary Completion Date

December 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Improvement in verbal short term memory [ Time Frame: 6 weeks ]

Change History

Complete list of historical versions of study NCT00588731 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Improvement in overall cognition as measured on the MATRICS Battery [ Time Frame: 6 weeks ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Cannabidiol Treatment of Cognitive Dysfunction in Schizophrenia

Official Title ^ICMJE

Cannabinoid Receptor Antagonist Treatment of Cognitive Dysfunction in Schizophrenia

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Schizophrenia
Schizoaffective Disorder

Intervention ^ICMJE

Drug: Cannabidiol
Active Cannabidiol daily over 6 weeks
Drug: Placebo
Placebo

Study Arms

Experimental: Cannabidiol
Intervention: Drug: Cannabidiol
Placebo Comparator: Placebo
Intervention: Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2013

Primary Completion Date

December 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years to 65 Years (Adult)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00588731

Other Study ID Numbers ^ICMJE

0710003164
07TGS-1082

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Mohini Ranganathan, Yale University

Study Sponsor ^ICMJE

Yale University

Collaborators ^ICMJE

Stanley Medical Research Institute

Investigators ^ICMJE

Principal Investigator:

Mohini Ranganathan, M.D.

Yale University

PRS Account

Yale University

Verification Date

June 2017

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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