Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
40 participants
OBSERVATIONAL
2023-10-18
2025-12-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Experimental: Ketamine Infusion
Participants who received 6 infusions of ketamine (0.5 mg/kg IV, up to 60 mg total), administered over 40 minutes while on continuous cardiac monitoring and oximetry in the ongoing clinical trial (KET-PD trial; NCT04944017, HIC 2000030394)
Cognitive Behavior Therapy (CBT)
Participants will receive 10 weeks of CBT
Treatment As Usual (TAU)
Participants will receive standard of care treatment
Placebo Comparator: Saline Infusion
Participants who received 6 infusions of placebo (saline IV), administered over 40 minutes while on continuous cardiac monitoring and oximetry in the ongoing clinical trial (KET-PD trial; NCT04944017, HIC 2000030394)
Cognitive Behavior Therapy (CBT)
Participants will receive 10 weeks of CBT
Treatment As Usual (TAU)
Participants will receive standard of care treatment
Interventions
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Cognitive Behavior Therapy (CBT)
Participants will receive 10 weeks of CBT
Treatment As Usual (TAU)
Participants will receive standard of care treatment
Eligibility Criteria
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Inclusion Criteria
40 Years
80 Years
ALL
No
Sponsors
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Fox (Michael J.) Foundation for Parkinson's Research
UNKNOWN
Yale School of Medicine Center for Brain Mind Health
UNKNOWN
Yale University
OTHER
Responsible Party
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Sophie Holmes
Assistant Professor of Psychiatry
Principal Investigators
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Sophie E. Holmes, PhD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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Yale New Haven Hospital
New Haven, Connecticut, United States
Countries
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Other Identifiers
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2000036071
Identifier Type: -
Identifier Source: org_study_id
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