Cannabidiol Treatment of Cognitive Dysfunction in Schizophrenia
Cannabinoid Receptor Antagonist Treatment of Cognitive Dysfunction in Schizophrenia
2 other identifiers
interventional
41
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 schizophrenia
Started Feb 2009
Longer than P75 for phase_2 schizophrenia
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 29, 2007
CompletedFirst Posted
Study publicly available on registry
January 9, 2008
CompletedStudy Start
First participant enrolled
February 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedResults Posted
Study results publicly available
June 8, 2017
CompletedJune 8, 2017
June 1, 2017
4.8 years
December 29, 2007
August 4, 2016
June 6, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Verbal Short Term Memory
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.
6 weeks
Secondary Outcomes (1)
Overall Cognition as Measured on the MATRICS Battery
6 weeks
Study Arms (2)
Cannabidiol
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Schizophrenia or Schizoaffective disorder (DSM-IV SCID-confirmed),
You may not qualify if:
- Women who are pregnant, nursing or unwilling to use appropriate birth control measures during study participation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yale Universitylead
- Stanley Medical Research Institutecollaborator
Study Sites (1)
Yale University
New Haven, Connecticut, 06511, United States
Related Publications (1)
Boggs DL, Surti T, Gupta A, Gupta S, Niciu M, Pittman B, Schnakenberg Martin AM, Thurnauer H, Davies A, D'Souza DC, Ranganathan M. The effects of cannabidiol (CBD) on cognition and symptoms in outpatients with chronic schizophrenia a randomized placebo controlled trial. Psychopharmacology (Berl). 2018 Jul;235(7):1923-1932. doi: 10.1007/s00213-018-4885-9. Epub 2018 Apr 5.
PMID: 29619533DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Mohini Ranganathan, M.D.
- Organization
- Yale University
Study Officials
- PRINCIPAL INVESTIGATOR
Mohini Ranganathan, M.D.
Yale University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
December 29, 2007
First Posted
January 9, 2008
Study Start
February 1, 2009
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
June 8, 2017
Results First Posted
June 8, 2017
Record last verified: 2017-06