Cannabidiol Treatment of Cognitive Dysfunction in Schizophrenia

Schizophrenia Clinical Trial

Official title:

Cannabinoid Receptor Antagonist Treatment of Cognitive Dysfunction in Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00588731
• Other study ID #: 0710003164
• Secondary ID: 07TGS-1082
• Status: Completed
• Phase: Phase 2
• First received: December 29, 2007
• Last updated: June 6, 2017
• Start date: February 2009
• Est. completion date: December 2013

Study information

• Verified date: June 2017
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

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

Locations

Country	Name	City	State
United States	Yale University	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	Stanley Medical Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall Cognition as Measured on the MATRICS Battery	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.	6 weeks