A Study of the Effects of not Allowing Sleep in Addition to the Usual Care of Hospitalized Patients with Major Depression
Overview
Tab Title Description
Study type
InterventionalDescribes 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: 13-006903
Sponsor Protocol Number: 13-006903
About this study
This study is to learn how effective a night of no sleep, with or without light therapy, is for patients in an inpatient setting who are experiencing Major depression.
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:
- Age > 18 years to age 65 at the time of admission, consistent with admission criteria for the Mood Disorders Unit at Mayo Clinic
- Major Depressive Disorder is, in the judgment of the team physician, the primary diagnosis
- The reason for admission, as per the judgment of the team physician, is exacerbation of depressive symptoms due to a worsening of MDD (see exclusion criteria below)
Exclusion Criteria:
- Admitted under involuntary orders
- Inability to understand written or spoken English
- Inability to provide valid written informed consent because of
- mental retardation
- an organic brain syndrome
- any other reason, as per the judgment of the team physician
- Primary diagnosis of a bipolar spectrum disorder (bipolar I or II disorder, or bipolar disorder not otherwise specified)
- The reasons for admission, as per the judgment of the team physician, are not related to exacerbation of MDD, e.g,
- an adjustment disorder
- axis II exacerbation
- effect of substances or substance abuse
- exacerbation of a comorbid psychiatric disorder
- Psychotic disorder or history of psychotic features
- History of seizure disorder
- History of light-induced migraine
- Retinal blindness, other retinal disease, severe cataracts, or glaucoma
- Severe agitation
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 Simon Kung, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available