Imaging Depression in Parkinson's Disease

NCT06402955 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2000037090R01NS125482-01A1
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to identify targetable neural substrates of depression in Parkinson's Disease for the first time in people with Parkinson's between the ages of 40 and 80, who are experiencing symptoms of depression.

Conditions

Parkinson's Disease; Major Depressive Disorder

Keywords

Imaging

Outcome Measures

Primary Outcomes (1)

• Montgomery-Åsberg Depression Rating Scale (MADRS)

  This assessment stratifies severity of depressive episodes in adults. Ratings are based on clinical interview with the patient. Use clinical judgment to determine whether the rating lies on the defined scale steps (0, 2, 4, 6 points) or between them (1, 3, 5 points, denoted as "(Worsening symptoms)").The MADRS scoring instructions indicate that a total score ranging from 0 to 6 indicates that the patient is in the normal range (no depression), a score ranging from 7 to 19 indicates "mild depression," 20 to 34 indicates "moderate depression," a score of 35 and greater indicates "severe depression," and a total score of 60 or greater indicates "very severe depression."

  One day

Secondary Outcomes (1)

• Binding potential (BPND)

  One week

Study Arms (1)

Parkinson's Disease with Major Depressive Disorder

OTHER

This study aims to identify mechanisms unique to patients with both Parkinson's Disease and Major Depressive Disorder.

Radiation: 11C-UCB-J; Drug: ketamine hydrochloride

Interventions

11C-UCB-J RADIATION

Radiotracer for imaging

Parkinson's Disease with Major Depressive Disorder

ketamine hydrochloride DRUG

There will be a small subset (opt-in) who will receive a single dose of ketamine to determine the ability of ketamine to target these mechanisms and initiate an associated antidepressant response. If the participant is opting into the ketamine arm, the investigators will ask them to come in for one single-dose of ketamine and complete another PET and MRI scan post-ketamine treatment.

Parkinson's Disease with Major Depressive Disorder

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 40-80.
• For women of reproductive potential, a negative pregnancy test at screening and scanning
• For PD patients, clinical diagnosis of PD, able to consent and tolerate PET procedures
• For PD depression patients - at least moderate symptom severity as determined by at least 15 on the MADRS, which has shown maximum discrimination between depressed and non-depressed PD patients.
• For dPD patients undergoing ketamine, abstinence from drugs of abuse, other than alcohol, cannabis, nicotine and caffeine for the duration of the study. Patients with substance use disorders as defined by the DSM-5 will be excluded.

You may not qualify if:

• Dementia (Montreal Cognitive Assessment (MoCA) score \<21)
• A significant primary DSM-5 psychiatric disorder except for MDD
• 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.
• Prior radiation exposure for research purposes within such that participation in this study would place them over FDA limits for annual radiation exposure
• Medications affecting SV2A availability (e.g. levetiracetam)
• For dPD patients receiving ketamine, 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.
• Contraindications to MRI.
• For patients undergoing arterial sampling for the PET scan: Iodine allergy, bleeding disorder and/or use of blood thinning medication
• Inability to provide written informed consent according to the Yale Human Investigation Committee (HIC) guidelines in English.

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): collaborator
• Yale University: lead

Study Sites (1)

Yale University

New Haven, Connecticut, 06520, United States

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Depressive Disorder, Major

Interventions

1-((3-(methylpyridin-4-yl)methyl)-4-(3,4,5-trifluorophenyl)pyrrolidin-2-one; Ketamine

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Sophie Holmes

CONTACT

2036854066; sophie.holmes@yale.edu

Libby DiDomizio

CONTACT

2039476313; libby.didomizio@yale.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry

Study Record Dates

• First Submitted: May 2, 2024
• First Posted: May 7, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: March 10, 2026

Record last verified: 2026-03

Locations

US (1)