Parkinson's DiseaseNCT06164756
Long Term Follow Up KET-PD
An observational study of Parkinson's Disease and Depression, run by Yale University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Parkinson's Disease, Depression
- What is being tested?
- Cognitive Behavior Therapy (CBT) and Treatment As Usual (TAU)
- Type of treatment
- Injection or infusion
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Oct 2023to 26 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A total of n=56 participants with PD and comorbid depression, age 40-80, are being recruited under the parent clinical trial. As of July 2023, 20 participants have been enrolled. We aim to follow-up our remaining participants longitudinally and, within this, to have 20 prospective participants receive CBT, such that we will have 20 participants in each follow-up arm (CBT vs. TAU), and ultimately 10 in each group (ketamine + CBT, ketamine + TAU, placebo + CBT, placebo + TAU).
Eligibility is determined in the ongoing parent clinical trial (KET-PD trial; NCT04944017, HIC 2000030394).
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale New Haven Hospital
New Haven, Connecticut, 06510
About this study
Official title: Long-Term Follow-Up for Subjects Enrolled in the Ketamine for the Treatment of Depression in Parkinson's Disease (KET-PD) Trial
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.
Read the 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.
- Conditions
- Parkinson's Disease, Depression
- Being tested
- Cognitive Behavior Therapy (CBT), Treatment As Usual (TAU)
- Keywords
- Long Term Effect Ketamine Treatment
- Medical subject headings
- Parkinson Disease, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavior Therapy (CBT)Other
Participants will receive 10 weeks of CBT
Treatment As Usual (TAU)Other
Participants will receive standard of care treatment
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Ketamine Infusion | 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) Receives: Other: Cognitive Behavior Therapy (CBT); Other: Treatment As Usual (TAU) | |
| Placebo Comparator: Saline Infusion | 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) Receives: Other: Cognitive Behavior Therapy (CBT); Other: Treatment As Usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 Months and 6 Months
Secondary outcomes (7)
Change in Apathy
Changes in apathy determined by the Starkstein Apathy Scale (SAS) scale
Measured: 3 Months and 6 Months
Change in Anxiety
Changes in anxiety determined by the State-Trait Anxiety Inventory (STAI) scale
Measured: 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
Measured: 3 Months and 6 Months
Change in Dyskinesia
Changes in dyskinesia determined by the Unified Dyskinesia Rating Scale (UDysRS) scale
Measured: 3 Months and 6 Months
Change in Pain
Changes in pain determined by the King's PD Pain Scale
Measured: 3 Months and 6 Months
Change in Fatigue
Changes in fatigue determined by the Parkinson's Fatigue Scale (PFS)
Measured: 3 Months and 6 Months
Change in Anhedonia
Changes in anhedonia determined by the Snaith-Hamilton Pleasure Scale (SHAPS)
Measured: 3 Months and 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start18 Oct 2023
- Primary completion16 Mar 2026
- Study completion26 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research, Yale School of Medicine Center for Brain Mind Health
- Responsible party
- Principal investigator, Sophie Holmes, Yale University
- Investigators
- Sophie E. Holmes, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06164756
- Sponsor's protocol ID
- 2000036071
- Status last verified
- Sep 2026
- First submitted
- 1 Dec 2023
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Follow-Up for Subjects Enrolled in the Ketamine for the Treatment of Depression in Parkinson's Disease (KET-PD) Trial
- ClinicalTrials.gov ID
- NCT06164756
- Acronym / sponsor ID
- 2000036071
- Conditions
- Parkinson's Disease, Depression
- Keywords
- Long Term Effect Ketamine Treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research, Yale School of Medicine Center for Brain Mind Health
- Study start
- 18 Oct 2023 (actual)
- Primary completion
- 16 Mar 2026 (actual)
- Study completion
- 26 Mar 2026 (actual)
- First posted
- 11 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Ketamine Infusion | – | Other: Cognitive Behavior Therapy (CBT), Other: Treatment As Usual (TAU)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) |
| Placebo Comparator: Saline Infusion | – | Other: Cognitive Behavior Therapy (CBT), Other: Treatment As Usual (TAU)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) |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of n=56 participants with PD and comorbid depression, age 40-80, are being recruited under the parent clinical trial. As of July 2023, 20 participants have been enrolled. We aim to follow-up our remaining participants longitudinally and, within this, to have 20 prospective participants receive CBT, such that we will have 20 participants in each follow-up arm (CBT vs. TAU), and ultimately 10 in each group (ketamine + CBT, ketamine + TAU, placebo + CBT, placebo + TAU).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavior Therapy (CBT)Participants will receive 10 weeks of CBT | Other | Experimental: Ketamine Infusion, Placebo Comparator: Saline Infusion |
| Treatment As Usual (TAU)Participants will receive standard of care treatment | Other | Experimental: Ketamine Infusion, Placebo Comparator: Saline Infusion |
Primary outcome
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.
7 secondary outcomes
Change in Apathy
Time frame: 3 Months and 6 Months
Change in Anxiety
Time frame: 3 Months and 6 Months
Change in Parkinson's Symptom Severity
Time frame: 3 Months and 6 Months
Change in Dyskinesia
Time frame: 3 Months and 6 Months
Change in Pain
Time frame: 3 Months and 6 Months
Change in Fatigue
Time frame: 3 Months and 6 Months
Change in Anhedonia
Time frame: 3 Months and 6 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sophie E. Holmes, PhD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease and Depression, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long-Term Change in Depression Severity (time frame: 3 Months and 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026; AzTrials last refreshed its copy on 30 Oct 2026.