Role of Slow-wave Activity and Plasticity in MDD (SWIP)

December 2, 2024 updated by: University of Pennsylvania

Investigating the Role of Slow-wave Activity as a Marker of Impaired Plasticity in Major Depressive Disorder

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

VISIT 1: Screening. Participants who meet initial inclusion criteria via phone screen will be invited to the laboratory for an in-person screening visit that includes additional screening (e.g. Medical history, TMS eligibility, hearing test for SW disruption procedure), and a structured clinical interview to determine final study eligibility. All subjects will receive verbal and written explanation of the general goals and risks of the study and will sign an informed consent. At this session, participants will also have the opportunity to become acquainted with the TMS and SW disruption procedures. In the case that remote visits are being utilized, such as during the COVID-19 pandemic, this will be separated into a virtual visit (consent, clinical interview, etc. - anything that can be conducted remotely will be) and an in-person visit (hearing test, TMS demonstration). Participants will also choose two dates, at least two nights apart and at most separated by two weeks, for the in-lab visits.

At-home Sleep Recording. For 7 days prior to the in-lab study visits, participants will be asked to keep a consistent at-home sleep schedule, based on habitual rise time (e.g., 10:30 PM - 6 AM). Participants will also consent to refraining from napping, using alcohol and drugs, and limiting caffeine use to one caffeinated beverage before noon throughout the study. These procedures will be confirmed using actigraphy, and sleep diary. Actigraphy provides a validated measure of sleep-wake patterns based on light and activity levels utilizing a wrist-watch like device (Actiwatch 2 and Actiwatch Spectrum Pro, Philips Respironics, Inc.). Sleep diaries will be used to document bedtime and rise time, and several other sleep parameters. Participants will also be asked to note if actigraphs were removed, for how long and for what purpose. Sleep diaries will be completed via the REDCap web-based application if participants have consistent Internet access. Paper and pencil versions of sleep diaries will also be available. Study staff will compare across these methods to verify adherence to study guidelines prior to the in-lab study.

VISIT 2: Baseline Night. Visit 2 and Visit 3 occur on two separate days, in a counterbalanced design to ensure no order or learning effects. The following procedure description will occur in half of participants where Visit 2 precedes Visit 3; however identical procedures will be used for the remaining half of participants where Visit 3 will precede Visit 2. Participants will arrive at the Clinical Research Center for Sleep (CRCS) at 8pm on Visit 2. Following their arrival and orientation, EEG electrodes will be applied. Participants sleep will then be monitored overnight. In the morning, participants will have their blood drawn, and after a light breakfast, the HAM-D will be administered, and then participants will be asked to fill out mood questionnaires (BDI, VAS, PANAS, KSS), and complete a battery of tasks including memory tasks, and resting EEG. They will then be accompanied to the Richards Building to complete the TMS protocol, before returning to the CRCS.

VISIT 3: Slow-wave Disruption. Procedures for Visit 3 are identical for those for Visit 2, with the exception of the following: Utilizing real-time EEG monitoring during sleep, left (C3) and right central (C4) channels will be continuously inspected. Whenever two delta waves (14 Hz; 75 V) appear within 15 seconds, an acoustic stimulus (i.e. tone; frequency = 1000 Hz; intensity = 20100 dB) will be administered through a speaker mounted above the bed, beginning with the lowest intensity (20 dB) and increased by 5 dB intervals if no response occurs (sleep stage shift, K complex, EEG desynchronization, mixed and fast frequency, alpha burst, muscle tone increase, slow eye movements). Utilizing this methodology, the type and incidence of tones played will be tailored to each participant to suppress slow waves without arousing the subject. Disruption of SWA will take place without waking the subject or decreasing total sleep time. The selective SW disruption procedure has been described in detail elsewhere.

TMS The TMS system is housed in the Richards Biomedical Building. Only individuals trained by the IDE sponsor (Desmond Oathes, Ph.D.) and Center Director (Yvette Sheline, M.D.) will dispense TMS. Since all TMS procedures are being conducted in Dr. Sheline's lab, all plans for receipt, storage, labelling, dispensing, returning of failed devices, and destruction will fall under the center's SOPs.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
77

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania, Department of Psychiatry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

25 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Subjects with Major Depressive Disorder
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
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.
Active Comparator: Control
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Compare Indices of Net Synaptic Strength (Transcranial Magnetic Stimulation Evoked Potentials) in Individuals With MDD to Healthy Controls
Time Frame: one month
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
Time Frame: one month
Brain-derived Neurotrophic Factor (BDNF) - Protein found in blood used to measure synaptic plasticity
one month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Determine if Slow-wave Disruption Alters Mood in Individuals With MDD
Time Frame: one month

Hamilton rating scale for depression - Clinician-administered measure of depression severity.

The Hamilton Depression Rating Scale is a 17-item, scale that includes questions about depressed mood, suicidal ideation, interest and motivation, irritability, and libido. Participants in this study completed a modified version, the HRSD-NOW (Leibenluft, Moul, Schwartz, Madden, & Wehr, 1993) during the study protocol, which prompts for responses in the context of the present moment and excludes items 4, 5, and 6 (insomnia symptoms), and item 16 (weight loss) which are less appropriate for multi-day assessment. Total scores could range from 0 to 44, with higher scores indicating greater severity of depressive symptomatology.
one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Pennsylvania

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Mental Health (NIMH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jennifer Goldschmied, PhD, University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 4, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 7, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 31, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 5, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 2, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 832986
  • K23MH118580 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

All subject data will be de-identified.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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