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Enrolling by Invitation

NCT Number: NCT06164756

Long Term Follow Up KET-PD

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.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Behavior Behavioral Symptoms Brain Diseases Central Nervous System Diseases Depression Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive Behavior Therapy (CBT)

Other

Participants will receive 10 weeks of CBT

Treatment as usual (TAU)

Other

Participants will receive standard of care treatment

Primary outcomes

  1. Long-Term Change in Depression Severity

    Time frame: 3 Months and 6 Months

    Change in MADRS score following course of ketamine vs. placebo treatment at 3 and 6 month timepoints; and change in MADRS across treatment (ketamine/placebo) and follow-up (CBT/TAU) arms at 3 and 6 month timepoints. The scale used to measure depression severity is called The Montgomery-Åsberg Depression Rating Scale (MADRS). The MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. The overall score ranges from 0 to 60, higher MADRS score indicates more severe depression.

Secondary outcomes

  1. Change in Apathy

    Time frame: 3 Months and 6 Months

    Changes in apathy determined by the Starkstein Apathy Scale (SAS) scale

  2. Change in Anxiety

    Time frame: 3 Months and 6 Months

    Changes in anxiety determined by the State-Trait Anxiety Inventory (STAI) scale

  3. Change in Parkinson's Symptom Severity

    Time frame: 3 Months and 6 Months

    Changes in Parkinson's symptom severity determined by the Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) scale

  4. Change in Dyskinesia

    Time frame: 3 Months and 6 Months

    Changes in dyskinesia determined by the Unified Dyskinesia Rating Scale (UDysRS) scale

  5. Change in Pain

    Time frame: 3 Months and 6 Months

    Changes in pain determined by the King's PD Pain Scale

  6. Change in Fatigue

    Time frame: 3 Months and 6 Months

    Changes in fatigue determined by the Parkinson's Fatigue Scale (PFS)

  7. Change in Anhedonia

    Time frame: 3 Months and 6 Months

    Changes in anhedonia determined by the Snaith-Hamilton Pleasure Scale (SHAPS)

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • Michael J. Fox Foundation for Parkinson's Research
  • Yale School of Medicine Center for Brain Mind Health

Registry information

Official study title

Long-Term Follow-Up for Subjects Enrolled in the Ketamine for the Treatment of Depression in Parkinson's Disease (KET-PD) Trial

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 11, 2023
Registry last updated
Jul 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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