Parkinson's Disease, Depression
Conditions
Keywords
Long Term Effect Ketamine Treatment
Brief 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.
Detailed 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.
Interventions
Participants will receive 10 weeks of CBT
OTHERTreatment As Usual (TAU)
Participants will receive standard of care treatment
Sponsors
Fox (Michael J.) Foundation for Parkinson's Research
Yale School of Medicine Center for Brain Mind Health
Yale University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Eligibility is determined in the ongoing parent clinical trial (KET-PD trial; NCT04944017, HIC 2000030394).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Long-Term Change in Depression Severity | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Anxiety | 3 Months and 6 Months | Changes in anxiety determined by the State-Trait Anxiety Inventory (STAI) scale |
| Change in Parkinson's Symptom Severity | 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 |
| Change in Dyskinesia | 3 Months and 6 Months | Changes in dyskinesia determined by the Unified Dyskinesia Rating Scale (UDysRS) scale |
| Change in Apathy | 3 Months and 6 Months | Changes in apathy determined by the Starkstein Apathy Scale (SAS) scale |
| Change in Fatigue | 3 Months and 6 Months | Changes in fatigue determined by the Parkinson's Fatigue Scale (PFS) |
| Change in Anhedonia | 3 Months and 6 Months | Changes in anhedonia determined by the Snaith-Hamilton Pleasure Scale (SHAPS) |
| Change in Pain | 3 Months and 6 Months | Changes in pain determined by the King's PD Pain Scale |
Countries
United States
Outcome results
None listed