COMPLETED

Ketamine for the Treatment of Depression in Parkinson's Disease

Conditions

Parkinson's Disease Depression Ketamine Treatment

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The main purpose of this study is to examine the efficacy and safety of a repeated dosing ketamine infusion paradigm compared to placebo in individuals with PD. A subset of participants in each arm will undergo baseline and post-treatment PET and fMRI scans, to examine whether changes in synaptic density and reorganization of functional networks underlie ketamine's putative antidepressant effects in PD.

Official Title

Ketamine for the Treatment of Depression in Parkinson's Disease (KET-PD)

Quick Facts

Study Start:2021-11-23

Study Completion:2025-09-24

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT04944017

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Male or female ages 40-80 years, inclusive 2. Clinical diagnosis of Parkinson's disease, stage 1, 2 or 3 as determined by the Hoehn and Yahr Scale 3. Meet criteria for major depressive disorder (MDD) as determined by the Mini-International Neuropsychiatric Interview (MINI), and at least 15 on the MADRS, which has shown maximum discrimination between depressed and non-depressed PD patients. 4. For women of reproductive potential, use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation, as well as a negative pregnancy test at screening. 5. Abstinence from drugs of abuse, other than alcohol, cannabis, nicotine and caffeine for the duration of the study. 6. Stated willingness to comply with all study procedures and availability for the duration of the study. 7. Provision of signed and dated informed consent form.	1. Presence of Dementia and a Montreal Cognitive Assessment (MoCA) score of less than 18. 2. A primary psychiatric disorder (as determined by the MINI) except for MDD 3. Active suicidal ideation with intent 4. History of substance dependence in the last 2 years 5. Current substance use disorder, except tobacco use disorder 6. Prior clinical psychiatric treatment with ketamine or prior recreational use of ketamine 7. A history of or current significant medical (e.g. cardiovascular, renal), or neurological (e.g. cerebrovascular, seizure, traumatic brain injury) illness other than PD that is unstable and significantly increase their risk and/or might affect the study objectives, as determined by study physicians 8. Uncontrolled hypertension, defined as average blood pressure greater than or equal to 140 mmHg or an average diastolic blood pressure greater than or equal to 90 mmHg among those patients who have hypertension. 9. Orthostatic hypotension (OH) that presents with symptoms sustained longer than a few minutes (e.g., light-headedness, blurred vision, dizziness, weakness, fatigue) or with syncope. OH is defined by a decrease in systolic blood pressure of 20 mm Hg or a decrease in diastolic blood pressure of 10 mm Hg within 3 minutes of standing compared with blood pressure from the sitting position. 10. Inability to provide written informed consent according to the Yale Human Investigation Committee (HIC) guidelines. 11. Any condition or finding that in the judgement of the PI significantly increases risk or significantly reduces the likelihood of benefit from participation in the study. 12. Prior radiation exposure for research purposes within such that participation in this study would place them over FDA limits for annual radiation exposure (5 rem per yr) 13. Contraindications to MRI scanning. 14. Presence of a bleeding disorder as determined by the PT/INR (Prothrombin time and international normalized ratio) test

Inclusion Criteria

Exclusion Criteria

1. Male or female ages 40-80 years, inclusive
2. Clinical diagnosis of Parkinson's disease, stage 1, 2 or 3 as determined by the Hoehn and Yahr Scale
3. Meet criteria for major depressive disorder (MDD) as determined by the Mini-International Neuropsychiatric Interview (MINI), and at least 15 on the MADRS, which has shown maximum discrimination between depressed and non-depressed PD patients.
4. For women of reproductive potential, use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation, as well as a negative pregnancy test at screening.
5. Abstinence from drugs of abuse, other than alcohol, cannabis, nicotine and caffeine for the duration of the study.
6. Stated willingness to comply with all study procedures and availability for the duration of the study.
7. Provision of signed and dated informed consent form.

1. Presence of Dementia and a Montreal Cognitive Assessment (MoCA) score of less than 18.
2. A primary psychiatric disorder (as determined by the MINI) except for MDD
3. Active suicidal ideation with intent
4. History of substance dependence in the last 2 years
5. Current substance use disorder, except tobacco use disorder
6. Prior clinical psychiatric treatment with ketamine or prior recreational use of ketamine
7. A history of or current significant medical (e.g. cardiovascular, renal), or neurological (e.g. cerebrovascular, seizure, traumatic brain injury) illness other than PD that is unstable and significantly increase their risk and/or might affect the study objectives, as determined by study physicians
8. Uncontrolled hypertension, defined as average blood pressure greater than or equal to 140 mmHg or an average diastolic blood pressure greater than or equal to 90 mmHg among those patients who have hypertension.
9. Orthostatic hypotension (OH) that presents with symptoms sustained longer than a few minutes (e.g., light-headedness, blurred vision, dizziness, weakness, fatigue) or with syncope. OH is defined by a decrease in systolic blood pressure of 20 mm Hg or a decrease in diastolic blood pressure of 10 mm Hg within 3 minutes of standing compared with blood pressure from the sitting position.
10. Inability to provide written informed consent according to the Yale Human Investigation Committee (HIC) guidelines.
11. Any condition or finding that in the judgement of the PI significantly increases risk or significantly reduces the likelihood of benefit from participation in the study.
12. Prior radiation exposure for research purposes within such that participation in this study would place them over FDA limits for annual radiation exposure (5 rem per yr)
13. Contraindications to MRI scanning.
14. Presence of a bleeding disorder as determined by the PT/INR (Prothrombin time and international normalized ratio) test

Contacts and Locations

Principal Investigator

Sophie E. Holmes, PhD

PRINCIPAL_INVESTIGATOR

Yale University

Study Locations (Sites)

Yale New Haven Hospital

New Haven, Connecticut, 06510

United States

Collaborators and Investigators

Sponsor: Yale University

Sophie E. Holmes, PhD, PRINCIPAL_INVESTIGATOR, Yale University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-11-23

Study Completion Date2025-09-24

Study Record Updates

Study Start Date2021-11-23

Study Completion Date2025-09-24

Terms related to this study

Keywords Provided by Researchers

Ketamine Treatment

Additional Relevant MeSH Terms

Parkinson's Disease
Depression