Role of Slow-wave Activity and Plasticity in MDD

NCT04150718 | Completed Results

• 2 other identifiers: 832986K23MH118580
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

Brief Summary

The hypothesis underlying this proposal is that deficits of synaptic plasticity underlie the slow-wave activity (SWA) abnormalities observed n major depressive disorder (MDD), and that manipulating SWA may serve to circumvent these deficits by facilitating an increase in synaptic strength via the inhibition of synaptic down-scaling, thereby improving plasticity and mood.

Conditions

Depression

Outcome Measures

Primary Outcomes (2)

• Compare Indices of Net Synaptic Strength (Transcranial Magnetic Stimulation Evoked Potentials) in Individuals With MDD to Healthy Controls

  Transcranial magnetic stimulation evoked potentials (MEP) - Measure of the amplitude of muscle movement from hand following TMS

  one month

• Compare Markers Associated With Plasticity (BDNF) in Individuals With MDD to Healthy Controls

  Brain-derived Neurotrophic Factor (BDNF) - Protein found in blood used to measure synaptic plasticity

  one month

Secondary Outcomes (1)

• Determine if Slow-wave Disruption Alters Mood in Individuals With MDD

  one month

Study Arms (2)

Subjects with Major Depressive Disorder

EXPERIMENTAL

Subjects who get assigned to this group will undergo a Diagnostic and Statistical Manual for Mental Disorders (SCID) assessment to determine is they meet criteria for MDD.

Behavioral: slow-wave disruption

Control

ACTIVE COMPARATOR

Subjects who get assigned to this group will undergo a Diagnostic and Statistical Manual for Mental Disorders (SCID) assessment to determine they do not meet criteria for MDD.

Behavioral: slow-wave disruption

Interventions

slow-wave disruption BEHAVIORAL

A tone will be played through a speaker mounted over the bed that disrupts subjects while they are in slow-wave sleep. The tone will not be loud enough to wake up.

Control; Subjects with Major Depressive Disorder

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age: 25-50
• Right handed
• English speaking
• Normal cognition
• Normal or corrected-to-normal vision and hearing
• Current depression as assessed on the SCID and Hamilton Rating Scale for Depression
• Stable, normally-time sleep-wake cycles as determined by interview, 1-week daily sleep log and 1-week wrist actigraphy evidence

You may not qualify if:

• Current or prior medical condition
• History of stroke, epilepsy, brain aneurysm clip or head injury causing unconsciousness
• Implanted devices (i.e. aneurysm clip or cardiac pacemaker)
• Sleep disorders other than insomnia
• History of bipolar disorder, delirium, dementia, amnestic disorder, schizophrenia and other psychotic disorders
• No history of depression for the control group.
• For women, pregnancy will exclude participation.
• Lifetime history of electroconvulsive therapy
• travel beyond 2 time zones in the 2 months before study
• Unwillingness to refrain from using alcohol or caffeine during the study

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Pennsylvania, Department of Psychiatry

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Limitations and Caveats

This study was conducted in a sample of individuals with MDD who were relatively young and physically healthy without significant sleep disturbance. Thus, this may not be generalizable to the larger population of individuals with MDD. Cortical excitability was also assessed as a proxy measure of synaptic strength. Because cortical excitability in the MEP of the APB muscle represents more than just synaptic strength, it may not accurately reflect changes in synaptic strength.

Results Point of Contact

• Title: Dr. Jennifer Goldschmied
• Organization: University of Pennsylvania

jrgolds2@pennmedicine.upenn.edu

215-573-2774

Study Officials

• Jennifer Goldschmied, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: October 7, 2019
• First Posted: November 5, 2019
• Study Start: March 4, 2020
• Primary Completion: March 31, 2023
• Study Completion: July 1, 2024
• Last Updated: December 27, 2024
• Results First Posted: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)