Long Term Follow Up KET-PD

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT06164756
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Cognitive Behavior Therapy (CBT) — OTHER
    Participants will receive 10 weeks of CBT
  • Treatment As Usual (TAU) — OTHER
    Participants will receive standard of care treatment

Study Details

The purpose of this study is to examine a) the longer-term effects of ketamine for treating depression in Parkinson's disease (PD) and b) the effects of CBT on maintaining the effects of ketamine.

Key Dates

Start date
Oct 18, 2023
Status verified
Jul 2025
Primary completion
Dec 21, 2025
Completion
Dec 21, 2025

Study Design

Enrollment
40 participants (estimated)

Arms

  • Arm: 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)
  • Arm: 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)

Primary Outcome Measure

Long-Term Change in Depression Severity [ Time Frame: 3 Months and 6 Months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Yale New Haven HospitalNew HavenConnecticut06510-

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