Cannabidiol Treatment in Patients With Early Psychosis



Status:Active, not recruiting
Conditions:Schizophrenia, Schizophrenia, Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 65
Updated:10/17/2018
Start Date:August 2015
End Date:December 2019

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Cannabidiol (CBD) is a component of herbal cannabis that is present in varying concentrations
in cannabis extracts. CBD has been shown to produce central effects including hypnotic,
anticonvulsive, anxiolytic and neuroprotective effects.The investigators hypothesize that
treatment with CBD will result in: 1) Improvement evidenced by a reduction in scores on the
Positive and Negative Syndrome Scale for Schizophrenia (PANSS), 2) Improvement evidenced by a
reduction in the Clinical Global Impression of Severity scale (CGI); Secondary Hypothesis: 1)
Greater improvement in functioning as measured on the "Patient Assessment of Own Functioning
Inventory: (PAOFI) and the Quality of Life Scale (QLS) In this 2 period cross over design,
subjects will be randomized in a 1:1 ratio to receive either: Order 1: CBD (Period 1)
followed by placebo (Period 2) or Order 2: Placebo (Period 1) followed by CBD (Period 2)
under double-blind conditions. The 2 study periods will be separated by a washout of at least
2 weeks. During each period subjects will receive study medications (CBD [total 800mg/day] or
placebo) for a period of 4 weeks.


Inclusion Criteria:

- Male or female

- Primary psychotic disorder

- Ages 18-65 (inclusive)

Exclusion Criteria:

- Current significant medical condition or other comorbidities

- Current substance depdendence

- Women who are pregnant or breastfeeding
We found this trial at
2
sites
950 Campbell Ave
West Haven, Connecticut 06516
(203) 932-5711
Principal Investigator: Mohini Ranganathan, MD
Phone: 203-932-5711
VA Connecticut Healthcare System VA Connecticut encompasses an inpatient facility and Ambulatory Care Center in...
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New Haven, Connecticut 06508
Principal Investigator: Mohini Ranganathan, MD
Phone: 203-974-7544
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New Haven, CT
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