Last updated: April 11, 2024
Sponsor: Hartford Hospital
Overall Status: Active - Not Recruiting
Phase
1/2
Condition
Progressive Supranuclear Palsy
Corticobasal Degeneration
Treatment
CBD
Placebo
Clinical Study ID
NCT04778644
HHC-2020-0367
Ages 18-50 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 18-50y/o
- Males and females of all races and ethnicities
- Able to provide written informed consent
- Able to read, speak, and understand English
- Meet DSM-IV (SCID-based) criteria for schizophrenia, schizoaffective disorder, bipolarI disorder with psychotic features OR healthy controlled with no diagnosed severemental illness
- No history of adverse normal baseline values for liver function tests (LFTs)
Exclusion
Exclusion Criteria:
- Strongly left-handed individuals defined as a 60:40 or greater ratio of left to righthand preference (assessed using the Edinburgh Handedness Inventory)
- Premorbid intellectual ability estimate below 70 (WRAT-4, Word Reading subtest,age-corrected standardized score)
- Comorbid DSM-IV diagnosis of alcohol or substance abuse in prior 1 month or substancedependence in prior 3 months
- Neurological (e.g., seizure disorder, stroke, traumatic brain injury with a loss ofconsciousness ≥ 30min) or severe medical condition (e.g., decompensated cardiovasculardisorder, AIDS) that may affect central nervous system function
- Concomitant medications that may interact with study drug adversely such as plateletinhibitors, benzodiazepines, or valproate
- Initial detection of abnormal liver function tests or previous medical history ofabnormal liver function or liver disease
- Vulnerable populations (e.g., pregnant, nursing, incarcerated); unwilling to usereliable means of contraception
- High risk for suicide defined as more than 1 attempt in past 12 months that requiredmedical attention, any attempt in the past 3 months or current suicidal ideation withplan and intent such that outpatient care is precluded
- Current homicidal ideation with plan and intent such that outpatient care is precluded
- Positive result on breathalyzer or positive urine toxicology test for any substance,including CBD
- History of prior allergic reaction with CBD or CBD-containing products
Study Design
Total Participants: 20
Treatment Group(s): 2
Primary Treatment: CBD
Phase: 1/2
Study Start date:
December 15, 2021
Estimated Completion Date:
December 15, 2025
Study Description
Connect with a study center
Hartford Hospital
Hartford, Connecticut 06106
United StatesSite Not Available
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