A Study of Brain Chemistry in Depressed Patients Compared to Healthy Patients Who are not Depressed
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 17-011223
Sponsor Protocol Number: 17-011223
About this study
The purpose of this study is to study brain chemistry in depressed patients compared to healthy patients who are not depressed.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Ages 12-18
- Primary diagnosis of major depressive disorder based on a structured diagnostic interview with the Mini International Neuropsychiatric Interview (M.I.N.I.)
- Score of 40 or greater on the Children’s Depression Rating Scale-Revised (CDRS-R)
- Participants must have the ability to commit to the study schedule for rTMS treatments.
- Healthy control participants will be between ages 12-18
- Healthy control participants will have no psychiatric diagnoses or unstable medical conditions (based on M.I.N.I and clinical interview)
Exclusion Criteria:
- Currently taking antidepressant medication.
- For potential depressed participants on antidepressant medication, the referring clinician must determine that insufficient benefit has been received from the treatment and it is clinically appropriate to discontinue the existing antidepressant prior to enrollment in the study.
- Currently in psychotherapy
- Stable treatment for 3 months prior to screening into the study with no anticipated change in the frequency or therapeutic focus of the sessions for the duration of study participation.
- Pregnancy
- Individuals diagnosed (based on M.I.N.I) with psychotic disorders, bipolar disorder, anorexia nervosa, bulimia nervosa
- History of neurological disorder or insult that might increase risk of seizure
- Contraindications to MRI/MRS or rTMS based on systematic safety screens such as implanted metal
- Prior brain surgery, risk for increased intracranial pressure such as a brain tumor
- Unstable medical condition based on principal investigator discretion.
- Active substance use within the past month (participants with a positive urine drug screen at baseline are excluded).
- Substance use disorders within the past year (with exception of caffeine or tobacco)
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Paul Croarkin, D.O., M.S. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available