Long Term Follow Up KET-PD

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Parkinson's Disease, Depression

Intervention / Treatment
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* Other: Cognitive Behavior Therapy (CBT)
* Other: Treatment As Usual (TAU)


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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ketamine Infusion<br>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) | Other: Cognitive Behavior Therapy (CBT)<br>* Participants will receive 10 weeks of CBT<br>Other: Treatment As Usual (TAU)<br>* Participants will receive standard of care treatment<br>|
| Placebo Comparator: Saline Infusion<br>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) | Other: Cognitive Behavior Therapy (CBT)<br>* Participants will receive 10 weeks of CBT<br>Other: Treatment As Usual (TAU)<br>* Participants will receive standard of care treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Apathy | Changes in apathy determined by the Starkstein Apathy Scale (SAS) scale | 3 Months and 6 Months | 
| Change in Anxiety | Changes in anxiety determined by the State-Trait Anxiety Inventory (STAI) scale | 3 Months and 6 Months | 
| 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 | 
| Change in Dyskinesia | Changes in dyskinesia determined by the Unified Dyskinesia Rating Scale (UDysRS) scale | 3 Months and 6 Months | 
| Change in Pain | Changes in pain determined by the King's PD Pain Scale | 3 Months and 6 Months | 
| Change in Fatigue | Changes in fatigue determined by the Parkinson's Fatigue Scale (PFS) | 3 Months and 6 Months | 
| Change in Anhedonia | Changes in anhedonia determined by the Snaith-Hamilton Pleasure Scale (SHAPS) | 3 Months and 6 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Long Term Effect Ketamine Treatment