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.
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.
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.
40-minute infusions; up to 60 mg total per infusion
Cognitive Behaviour Therapy (remote, post-infusions; duration reported as 10 weeks and elsewhere as 3 months)
Treatment as usual (TAU)
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.
Saline placebo, 40-minute infusions
Cognitive Behaviour Therapy (remote, post-infusions; duration reported as 10 weeks and elsewhere as 3 months)
Treatment as usual (TAU)
No exclusion criteria listed.