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Completed

NCT Number: NCT00588731

Cannabidiol Treatment of Cognitive Dysfunction in Schizophrenia

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.

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Key information

Conditions

Schizophrenia Mental Disorders Psychotic Disorders Schizoaffective Disorder Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Yale University

New Haven, Connecticut, 06511, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cannabidiol

Drug

Active Cannabidiol daily over 6 weeks

Placebo

Drug

Placebo

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • Stanley Medical Research Institute

Registry information

Official study title

Cannabinoid Receptor Antagonist Treatment of Cognitive Dysfunction in Schizophrenia

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Jan 9, 2008
Registry last updated
Jun 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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