Cannabidiol Treatment of Cognitive Dysfunction in Schizophrenia

Phase 2

Completed

• Conditions: Schizophrenia; Schizoaffective Disorder
• Interventions: Drug: Placebo; Drug: Cannabidiol

• Registration Number: NCT00588731
• Lead Sponsor: Yale University

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 available

Study Timeline

• Study First Submitted: 2007-12-29
• Study First Submitted QC: 2008-01-08
• Study First Posted: 2008-01-09
• Study Start: 2009-02
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Results First Submitted: 2016-08-04
• Status Verified: 2017-06
• Results First Submitted QC: 2017-06-06
• Last Update Submitted: 2017-06-06
• Results First Posted: 2017-06-08
• Last Update Posted: 2017-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

• Schizophrenia or Schizoaffective disorder (DSM-IV SCID-confirmed),

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Exclusion Criteria

• Women who are pregnant, nursing or unwilling to use appropriate birth control measures during study participation.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Cannabidiol	Cannabidiol	-

Primary Outcome Measures

Name	Time	Method
Verbal Short Term Memory	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

Name	Time	Method
Overall Cognition as Measured on the MATRICS Battery	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.

Trial Locations

Locations (1)

Yale University; 🇺🇸 New Haven, Connecticut, United States