Clinical trial NCT02504151: Cannabidiol Treatment in Patients With Early Psychosis
Official title: Cannabidiol Treatment in Patients With Early Psychosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Schizophrenia
Schizoaffective Disorder
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2015-07-21
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Positive and Negative Syndrome Scale (PANSS) Over Time
timeFrame: Completed each time subject is seen over 10 weeks (screening, period 1 baseline, period 1 week 1, period 1 week 2, period 1 week 3, period 1 week 4, period 2 baseline, period 2 week 1, period 2 week 2, period 2 week 3, period 2 week 4)
measure: Clinical Global Impression of Severity Scale Over Time
timeFrame: Completed each time subject is seen over 10 weeks (screening, period 1 baseline, period 1 week 1, period 1 week 2, period 1 week 3, period 1 week 4, period 2 baseline, period 2 week 1, period 2 week 2, period 2 week 3, period 2 week 4)
Secondary outcomes:
measure: Patient Assessment of Own Functioning Inventory (PAOFI) Over Time
timeFrame: Completed each time subject is seen over 10 weeks (screening, period 1 baseline, period 1 week 1, period 1 week 2, period 1 week 3, period 1 week 4, period 2 baseline, period 2 week 1, period 2 week 2, period 2 week 3, period 2 week 4)
measure: Quality of Life Scale (QLS) Over Time
timeFrame: Completed each time subject is seen over 10 weeks (screening, period 1 baseline, period 1 week 1, period 1 week 2, period 1 week 3, period 1 week 4, period 2 baseline, period 2 week 1, period 2 week 2, period 2 week 3, period 2 week 4)
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Connecticut Mental Health Center
state: Connecticut
city: West Haven
country: United States
facility: VA Connecticut Healthcare System
state: Connecticut
Study officials:
References: