Neural Mechanisms Underlying the Antidepressant Effects of Sleep Deprivation

Depression, Unipolar Clinical Trial

Official title:

Neural Mechanisms Underlying the Antidepressant Effects of Sleep Deprivation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03169543
• Other study ID #: 811678
• Status: Completed
• Phase: N/A
• Start date: April 1, 2016
• Est. completion date: February 28, 2020

Study information

• Verified date: March 2020
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 28, 2020
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression, Unipolar
• Depressive Disorder
• Sleep Deprivation

Intervention

Behavioral:
• Sleep deprivation
36-hours total sleep deprivation

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in neuroimaging	Resting-state brain functional connectivity on fMRI	Each morning for 3 days