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Imaging Depression in Parkinson's Disease

Identifying the Neural Basis of Depression in Parkinson's Disease

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years to 80 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 1 visit
  • Procedures mentioned: MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants will be asked to complete one PET and one MRI scan along with study assessments."
  • "Once screening and consent is completed, participants will be scheduled for PET and MRI scans."
  • "The total duration for participants in this study is 7 hours, including the screening visit and then one additional visit for the scans."
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study uses brain scans to look for brain changes linked to depression in Parkinson’s disease. These changes may be targets for treatment. The study is for people ages 40 to 80 with Parkinson’s disease and symptoms of depression.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 40 to 80 years old.
  • Women who could become pregnant must have a negative pregnancy test at screening and at scanning.
  • People with Parkinson’s must have a doctor’s diagnosis, be able to agree to join, and be able to have PET scans, a type of imaging test.
  • People in the Parkinson’s depression group must have at least moderate depression, with a score of 15 or higher on the MADRS depression scale.
  • People receiving ketamine must avoid drugs of abuse during the study, except alcohol, cannabis, nicotine, and caffeine. They cannot have a substance use disorder.

Who can't join

  • Dementia, defined as a score below 21 on the MoCA memory and thinking test.
  • A major mental health disorder other than major depression.
  • An unstable, serious medical or brain illness other than Parkinson’s that study doctors believe could raise risks or affect study results.
  • Past research radiation exposure that, with this study, would go over the FDA’s yearly limit.
  • Taking medicines that affect the brain protein SV2A, such as levetiracetam.
  • For people receiving ketamine who have high blood pressure: an average top number of 140 or higher, or bottom number of 90 or higher.
  • Any reason an MRI scan would be unsafe. For those having blood drawn from an artery for PET: an iodine allergy, a bleeding disorder, or use of blood thinners.
  • Being unable to give written consent in English under Yale’s research review rules.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. Age 40-80. 2. For women of reproductive potential, a negative pregnancy test at screening and scanning 3. For PD patients, clinical diagnosis of PD, able to consent and tolerate PET procedures 4. 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. 5. 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. Exclusion Criteria: 1. Dementia (Montreal Cognitive Assessment (MoCA) score \<21) 2. A significant primary DSM-5 psychiatric disorder except for MDD 3. 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. 4. Prior radiation exposure for research purposes within such that participation in this study would place them over FDA limits for annual radiation exposure 5. Medications affecting SV2A availability (e.g. levetiracetam) 6. 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. 7. Contraindications to MRI. 8. For patients undergoing arterial sampling for the PET scan: Iodine allergy, bleeding disorder and/or use of blood thinning medication 9. Inability to provide written informed consent according to the Yale Human Investigation Committee (HIC) guidelines in English.

Study sites (1)

CT