Clinical TrialDepressive DisordersKetaminePlaceboEnrolling by invitation

Long Term Follow Up KET-PD

This observational cohort study (n=40), conducted by Yale University, aims to explore the long-term effects of ketamine for treating depression in Parkinson's disease (PD) and assess the impact of Cognitive Behaviour Therapy (CBT) on maintaining the effects of ketamine.

Target Enrollment
40 participants
Study Type
Phase NA observational
Design
Non-randomized

Detailed Description

This prospective roll-out cohort follows participants from the parent KET-PD trial to examine longer-term antidepressant effects of ketamine versus placebo and whether post‑infusion CBT sustains response compared with treatment as usual (TAU). Assessments occur at 3 and 6 months post‑infusions.

Participants previously received six IV infusions (ketamine 0.5 mg/kg, up to 60 mg per infusion, administered over 40 minutes) or saline placebo; follow-up arms allocate participants to remote weekly CBT or TAU. The study uses an implementation science approach across ketamine and placebo groups.

Target enrolment is 40 follow-up participants drawn from the parent trial; Yale New Haven Hospital is the listed facility and Yale University is the sponsor.

Study Protocol

Preparation

sessions

Dosing

6 sessions
40 min each

Integration

sessions

Therapeutic Protocol

cbt

Study Arms & Interventions

Ketamine infusions

experimental

Participants who received six IV infusions of ketamine (0.5 mg/kg, up to 60 mg total) over 40 minutes as part of the parent KET-PD trial; followed by either CBT or TAU.

Interventions

  • Ketamine0.5 mg/kg
    via IV• six infusions• 6 doses total

    40-minute infusions; up to 60 mg total per infusion

  • Compound
    via Other• weekly

    Cognitive Behaviour Therapy (remote, post-infusions; duration reported as 10 weeks and elsewhere as 3 months)

  • Compound
    via Other

    Treatment as usual (TAU)

Saline infusions

inactive

Participants who received six IV saline placebo infusions over 40 minutes as part of the parent KET-PD trial; followed by either CBT or TAU.

Interventions

  • Placebo
    via IV• six infusions• 6 doses total

    Saline placebo, 40-minute infusions

  • Compound
    via Other• weekly

    Cognitive Behaviour Therapy (remote, post-infusions; duration reported as 10 weeks and elsewhere as 3 months)

  • Compound
    via Other

    Treatment as usual (TAU)

Participants

Ages
40 – 80
Sexes
Male & Female

Inclusion Criteria

  • Eligibility is determined in the ongoing parent clinical trial (KET-PD trial; NCT04944017, HIC 2000030394).

Exclusion Criteria

No exclusion criteria listed.

Study Details

  • Status
    Enrolling by invitation
  • Phase
    Phase NA
  • Type
    observational
  • Design
    Non-randomized
  • Target Enrollment40 participants
  • Timeline
    Start: 2023-10-18
    End: 2025-12-31
  • Compounds
    KetaminePlacebo
  • Topic
    Depressive Disorders

Locations

Yale New Haven Hospital — New Haven, Connecticut, United States

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