Neural Mechanisms Underlying the Antidepressant Effects of Sleep Deprivation

Sponsor
University of Pennsylvania (Other)
Overall Status
Completed
CT.gov ID
NCT03169543
Collaborator
(none)
50
1
1
46.9
1.1

Study Details

Study Description

Brief Summary

From 40 to 60% of patients with depression experience a rapid and significant improvement of mood with one night of sleep deprivation (SD). The neural mechanisms underlying this effect have not been elucidated. Recent advances in functional neuroimaging have provided new opportunities to investigate state changes in regional brain function, along with a better understanding of the neural networks affected by depression and SD. Here we propose to study a group of N=48 antidepressant-free male and female patients with current depression symptom and N=12 healthy controls with no history of mood disorders before and after SD to provide mechanistic insight into the neural substrates underlying the antidepressant effects of SD. We hypothesize that SD-induced concurrent functional activity and connectivity changes in multiple brain networks related to different depressive symptom dimensions including emotion regulation, attention, arousal, self-referential, and reward processing will underlie the rapid and transient antidepressant effects of SD. Using an ABA design, multimodal brain imaging along with more traditional electroencephalographic (EEG) and neurobehavioral testing data will be acquired at baseline after normal sleep, during one night of total SD, and after one night of recovery sleep using a 5-day in laboratory protocol during which subjects will be continuously monitored by trained staff.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Sleep deprivation
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Neural Mechanisms Underlying the Antidepressant Effects of Sleep Deprivation
Actual Study Start Date :
Apr 1, 2016
Actual Primary Completion Date :
Feb 28, 2020
Actual Study Completion Date :
Feb 28, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Sleep deprivation

36-hours of total sleep deprivation

Behavioral: Sleep deprivation
36-hours total sleep deprivation

Outcome Measures

Primary Outcome Measures

  1. Change in HAMD-NOW scores [Each morning for 4 days]

    Total score on a modified Hamilton Depression Inventory that assesses mood symptoms in the moment.

Secondary Outcome Measures

  1. Change in neuroimaging [Each morning for 3 days]

    Resting-state brain functional connectivity on fMRI

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Current depression as assessed on the HDRS-17 (for depressed group only)

  • Body mass index within 15% of normal

  • Stable, normally-timed sleep-wake cycle defined by: a. Habitual nocturnal sleep duration between 6h and 9h. b. Habitual morning awakening between 0600h and 0800h.

  • Able to comprehend English, as all questionnaires are in this language

  • Ability to provide informed consent

Exclusion Criteria:
  • Shift work, transmeridian travel or irregular sleep/wake routine in past 60 days

  • A sleep disorder other than insomnia

  • History of bipolar disorder, delirium, dementia, amnestic disorder, schizophrenia and other psychotic disorders

  • No history of depression for the control group.

  • Alcohol or drug abuse in the past year

  • A current smoker.

  • Any acute or chronic, debilitating medical conditions, epilepsy, or thyroid disease.

  • Metallic implants, pacemakers or tattoos, or history of working in metal workshops.

  • Claustrophobic, or intolerant of the scanner environment.

  • For women, pregnancy will exclude participation.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Pennsylvania Philadelphia Pennsylvania United States 19104

Sponsors and Collaborators

  • University of Pennsylvania

Investigators

  • Principal Investigator: Philip Gehrman, PhD, University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT03169543
Other Study ID Numbers:
  • 811678
First Posted:
May 30, 2017
Last Update Posted:
Mar 25, 2020
Last Verified:
Mar 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 25, 2020