Actively Recruiting

Phase 2
Age: 40Years - 80Years
All Genders
Healthy Volunteers
NCT06402955

Imaging Depression in Parkinson's Disease

Led by Yale University · Updated on 2026-03-10

120

Participants Needed

1

Research Sites

273 weeks

Total Duration

On this page

Sponsors

Y

Yale University

Lead Sponsor

N

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Imaging Depression in Parkinson's Disease

Who Can Participate

Age: 40Years - 80Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 40 to 80 years
  • Negative pregnancy test for women of reproductive potential at screening and scanning
  • Clinical diagnosis of Parkinson's Disease and ability to consent and tolerate PET procedures
  • For Parkinson's patients with depression, at least moderate symptom severity (MADRS score of 15 or higher)
  • For depressed Parkinson's patients receiving ketamine, abstinence from drugs of abuse except alcohol, cannabis, nicotine, and caffeine during the study; no substance use disorder as defined by DSM-5
Not Eligible

You will not qualify if you...

  • Dementia with Montreal Cognitive Assessment (MoCA) score less than 21
  • Significant primary psychiatric disorder other than major depressive disorder
  • Unstable or significant medical or neurological illness other than Parkinson's Disease that increases risk or affects study objectives
  • Prior research radiation exposure exceeding FDA annual limits
  • Use of medications affecting SV2A availability (e.g., levetiracetam)
  • For ketamine patients, uncontrolled hypertension (blood pressure ≥140/90 mmHg)
  • Contraindications to MRI
  • For arterial sampling in PET scan: iodine allergy, bleeding disorder, or use of blood-thinning medication
  • Inability to provide written informed consent according to Yale Human Investigation Committee guidelines in English

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Yale University

New Haven, Connecticut, United States, 06520

Actively Recruiting

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Research Team

S

Sophie Holmes

CONTACT

L

Libby DiDomizio

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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