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DEPRESSION STUDY: INVESTIGATING LINKS BETWEEN SLEEP AND MOOD

GOAL: This research study aims to examine the role of slow-wave sleep activity in improving mood in individuals with Major Depressive Disorder (MDD).
TARGET POPULATION: We are looking for 40 currently depressed males and females and 20 healthy controls with no history of depression between the ages of 25-50. Participants must taper off of any psychiatric medication for duration of the study.
PARTICIPATION: Participation lasts for approximately one month. Participants will attend an initial 3-hour screening session (2-hour virtual, 1-hour in-person). Then, they will participate in one baseline night of sleep and one night where slow-wave sleep will be disrupted at the Hospital of the University of Pennsylvania Sleep Lab. Following each laboratory night, participants will complete a variety of tasks and questionnaires, including protocol for transcranial magnetic stimulation (TMS).
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Detailed Description

Research procedures:
  1. 2-hour virtual screening session: discuss study details, sign consent form, complete questionnaires, interview about history of mental health symptoms
  2. 1-hour in-person visit (3535 Market Street): demonstration of TMS procedures, hearing test
  3. One week prior to overnight visits: wear a wrist-worn device to measure activity levels during the day and at night, fill out sleep diary every morning about previous night's sleep
  4. 2 overnight visits (Sleep Center at HUP): arrive at 8pm, wear sensors to measure your sleep; next morning, you will have a blood sample taken, be provided with breakfast, complete a few tasks, and complete the TMS protocol (ends around 11:30am at the latest); one of these two nights, tones will be played through a speaker to disrupt deep sleep without waking you up, the other night is baseline
Benefits of participation include contributing to the discovery of links between depressed mood and sleep, and contributing to a potential novel treatment for depression.  Risks include mild discomfort with blood draw and/or electrode placement, sleepiness/fatigue after disruption visit, and risks associated with TMS.

Compensation is $275 in total if you complete all study requirements.

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Call 1800-9860-568 now to find out if you are eligible.

Age

25 - 50

Gender

Female

NCT ID

TX832986

Phase

0

Status

Recruiting Now

Medical Condition

Depression

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Medical Condition

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The Study

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About Clinical Trials

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Your Journey

01
Receiving the medication

You would receive etanercept (Enbrel) twice a week for 12 weeks and then once a week for 12 weeks. Etanercept, as well as study related medical care, is provided at no cost.

02
Visiting the study site

Study participation involves approximately 8 visits to your local study center over 6 to 7 months.

03
Follow-up

There would also be a follow-up telephone call 30days after completing the study. No visits are required after participation is complete.

Call 1800-9860-568 now to find out if you are eligible.