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

Primary Purpose

Depression

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
slow-wave disruption
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Depression

Eligibility Criteria

25 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Pennsylvania, Department of Psychiatry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Subjects with Major Depressive Disorder

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Compare indices of net synaptic strength (theta power, transcranial magnetic stimulation evoked potentials) and markers associated with plasticity (BDNF, behavioral measures of learning/memory) in individuals with MDD to healthy controls
Waking EEG Theta power - Brain rhythm assessed during waking used to measure net synaptic strength

Secondary Outcome Measures

Determine if slow-wave disruption alters mood in individuals with MDD
Hamilton rating scale for depression - Clinician-administered measure of depression severity

Full Information

First Posted
October 7, 2019
Last Updated
August 3, 2023
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT04150718
Brief Title
Role of Slow-wave Activity and Plasticity in MDD
Acronym
SWIP
Official Title
Investigating the Role of Slow-wave Activity as a Marker of Impaired Plasticity in Major Depressive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 4, 2020 (Actual)
Primary Completion Date
March 31, 2023 (Actual)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Subjects with Major Depressive Disorder
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
slow-wave disruption
Intervention Description
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.
Primary Outcome Measure Information:
Title
Compare indices of net synaptic strength (theta power, transcranial magnetic stimulation evoked potentials) and markers associated with plasticity (BDNF, behavioral measures of learning/memory) in individuals with MDD to healthy controls
Description
Waking EEG Theta power - Brain rhythm assessed during waking used to measure net synaptic strength
Time Frame
up to a month
Secondary Outcome Measure Information:
Title
Determine if slow-wave disruption alters mood in individuals with MDD
Description
Hamilton rating scale for depression - Clinician-administered measure of depression severity
Time Frame
up to a month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Goldschmied, PhD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania, Department of Psychiatry
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
All subject data will be de-identified.

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Role of Slow-wave Activity and Plasticity in MDD

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