Long Term Follow Up KET-PD

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06164756
• Other study ID #: 2000036071
• Status: Enrolling by invitation
• Start date: October 18, 2023
• Est. completion date: December 2025

Study information

• Verified date: December 2023
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: December 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Parkinson Disease
• Parkinson's Disease

Intervention

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

Locations

Country	Name	City	State
United States	Yale New Haven Hospital	New Haven	Connecticut

Sponsors (3)

Lead Sponsor	Collaborator
Yale University	Fox (Michael J.) Foundation for Parkinson's Research, Yale School of Medicine Center for Brain Mind Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Long-Term Change in Depression Severity	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.	3 Months and 6 Months
Secondary	Change in Apathy	Changes in apathy determined by the Starkstein Apathy Scale (SAS) scale	3 Months and 6 Months
Secondary	Change in Anxiety	Changes in anxiety determined by the State-Trait Anxiety Inventory (STAI) scale	3 Months and 6 Months
Secondary	Change in Parkinson's Symptom Severity	Changes in Parkinson's symptom severity determined by the Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) scale	3 Months and 6 Months
Secondary	Change in Dyskinesia	Changes in dyskinesia determined by the Unified Dyskinesia Rating Scale (UDysRS) scale	3 Months and 6 Months
Secondary	Change in Pain	Changes in pain determined by the King's PD Pain Scale	3 Months and 6 Months
Secondary	Change in Fatigue	Changes in fatigue determined by the Parkinson's Fatigue Scale (PFS)	3 Months and 6 Months
Secondary	Change in Anhedonia	Changes in anhedonia determined by the Snaith-Hamilton Pleasure Scale (SHAPS)	3 Months and 6 Months