Long Term Follow Up KET-PD

Yale University

Status: Invitation-only

Conditions: Parkinson's Disease; Depression

Treatments: Other: Cognitive Behavior Therapy (CBT); Other: Treatment As Usual (TAU)

Study type: Observational

Funder types: Other

Identifiers

NCT06164756

2000036071

Details and patient eligibility

About

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.

Full description

This is a roll-out study from the ongoing clinical trial (KET-PD trial; NCT04944017, HIC 2000030394). We will adopt an implementation science approach to have participants across ketamine and placebo groups in one of two arms: a) follow-up with treatment as usual (TAU) (at 3 and 6 months post-infusions); b) follow-up with 3 months of Cognitive Behavior Therapy (CBT) post-infusions, delivered remotely once per week, with follow-up assessments at 3 and 6 month timepoints. CBT is expected to have a superior sustained antidepressant response to the TAU follow-up group in both ketamine and placebo arms. We hypothesize that ketamine + CBT will show the most superior antidepressant response at follow-up.

Enrollment: 40 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

40 participants in 2 patient groups

Experimental: Ketamine Infusion

Description:

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)

Treatment:

Other: Treatment As Usual (TAU)

Other: Cognitive Behavior Therapy (CBT)

Placebo Comparator: Saline Infusion

Description:

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)

Treatment:

Other: Treatment As Usual (TAU)

Other: Cognitive Behavior Therapy (CBT)