Neural Mechanisms Underlying the Antidepressant Effects of Sleep Deprivation

NCT03169543 | Completed

• 1 other identifier: 811678
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression, Unipolar

Outcome Measures

Primary Outcomes (1)

• Change in HAMD-NOW scores

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

  Each morning for 4 days

Secondary Outcomes (1)

• Change in neuroimaging

  Each morning for 3 days

Study Arms (1)

Sleep deprivation

EXPERIMENTAL

36-hours of total sleep deprivation

Behavioral: Sleep deprivation

Interventions

Sleep deprivation BEHAVIORAL

36-hours total sleep deprivation

Sleep deprivation

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Depressive Disorder

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders

Study Officials

• Philip Gehrman, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2017
• First Posted: May 30, 2017
• Study Start: April 1, 2016
• Primary Completion: February 28, 2020
• Study Completion: February 28, 2020
• Last Updated: March 25, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)