Trial Outcomes & Findings for Role of Slow-wave Activity and Plasticity in MDD (NCT NCT04150718)
NCT ID: NCT04150718
Last Updated: 2024-12-27
Results Overview
Transcranial magnetic stimulation evoked potentials (MEP) - Measure of the amplitude of muscle movement from hand following TMS
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
77 participants
Primary outcome timeframe
one month
Results posted on
2024-12-27
Participant Flow
Participant milestones
| Measure |
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.
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.
|
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.
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.
|
Unassigned Due to Ineligibility/Withdrawal
These individuals were either deemed ineligible or withdrew prior to the diagnostic interview and were therefore unassigned to a diagnostic group
|
|---|---|---|---|
|
Overall Study
STARTED
|
24
|
42
|
11
|
|
Overall Study
COMPLETED
|
20
|
33
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
9
|
11
|
Reasons for withdrawal
| Measure |
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.
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.
|
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.
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.
|
Unassigned Due to Ineligibility/Withdrawal
These individuals were either deemed ineligible or withdrew prior to the diagnostic interview and were therefore unassigned to a diagnostic group
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
7
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
0
|
|
Overall Study
Ineligible
|
1
|
0
|
10
|
Baseline Characteristics
Role of Slow-wave Activity and Plasticity in MDD
Baseline characteristics by cohort
| Measure |
Subjects With Major Depressive Disorder
n=33 Participants
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.
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.
|
Control
n=20 Participants
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.
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.
|
Ineligible/Withdrew
n=11 Participants
Results are reported per Arm/Group, but data from participants who were ineligible or withdrew were not included in the analysis, as we were not able to collect data from these participants. Therefore, these Arms/Groups are not represented in the reported results.
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
33 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
64 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
31 years
STANDARD_DEVIATION 5.32 • n=5 Participants
|
32.68 years
STANDARD_DEVIATION 7.03 • n=7 Participants
|
NA years
STANDARD_DEVIATION NA • n=5 Participants
|
31.63 years
STANDARD_DEVIATION 6.00 • n=4 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
NA Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
NA Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
NA Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
NA Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
NA Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
NA Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
NA Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
NA Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
NA Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
33 participants
n=5 Participants
|
20 participants
n=7 Participants
|
11 participants
n=5 Participants
|
53 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: one monthPopulation: Due to technical problems with the TMS protocol, data from N=8 MDD, and N=6 HC were not able to be analyzed. Additionally, N=1 HC was found to have Obstructive sleep apnea, and was thus excluded, and N=1 MDD was found to have had ingested alcohol prior to the experimental night and was thus excluded from analysis.
Transcranial magnetic stimulation evoked potentials (MEP) - Measure of the amplitude of muscle movement from hand following TMS
Outcome measures
| Measure |
Subjects With Major Depressive Disorder
n=24 Participants
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.
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.
|
Control
n=13 Participants
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.
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.
|
|---|---|---|
|
Compare Indices of Net Synaptic Strength (Transcranial Magnetic Stimulation Evoked Potentials) in Individuals With MDD to Healthy Controls
MEP at Baseline
|
195.07 millivolts (mV)
Standard Deviation 99.72
|
179.16 millivolts (mV)
Standard Deviation 74.24
|
|
Compare Indices of Net Synaptic Strength (Transcranial Magnetic Stimulation Evoked Potentials) in Individuals With MDD to Healthy Controls
MEP after slow-wave disruption
|
323.22 millivolts (mV)
Standard Deviation 286.94
|
212.73 millivolts (mV)
Standard Deviation 198.54
|
PRIMARY outcome
Timeframe: one monthPopulation: Due to difficulties with blood collection, data from N=5 MDD, and N=5 HC were not able to be analyzed. Additionally, N=1 HC was found to have Obstructive sleep apnea and was thus excluded, and N=1 MDD was found to have had ingested alcohol prior to the experimental night and was thus excluded from analysis.
Brain-derived Neurotrophic Factor (BDNF) - Protein found in blood used to measure synaptic plasticity
Outcome measures
| Measure |
Subjects With Major Depressive Disorder
n=27 Participants
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.
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.
|
Control
n=14 Participants
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.
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.
|
|---|---|---|
|
Compare Markers Associated With Plasticity (BDNF) in Individuals With MDD to Healthy Controls
Plasma BDNF at Baseline
|
1599.80 pg/ml
Standard Deviation 1010.78
|
1738.32 pg/ml
Standard Deviation 1248.35
|
|
Compare Markers Associated With Plasticity (BDNF) in Individuals With MDD to Healthy Controls
Plasma BDNF after Slow-wave Disruption
|
2839.79 pg/ml
Standard Deviation 3507.37
|
2860.74 pg/ml
Standard Deviation 2590.43
|
SECONDARY outcome
Timeframe: one monthPopulation: N=1 HC was found to have Obstructive sleep apnea, and was thus excluded, and N=1 MDD was found to have had ingested alcohol prior to the experimental night and was thus excluded from analysis. Additionally, N=1 HC did not complete the HAM-D at one time point and was thus excluded from analysis.
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.
Outcome measures
| Measure |
Subjects With Major Depressive Disorder
n=32 Participants
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.
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.
|
Control
n=18 Participants
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.
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.
|
|---|---|---|
|
Determine if Slow-wave Disruption Alters Mood in Individuals With MDD
HAM-D at Baseline
|
5.25 score on a scale
Standard Deviation 2.98
|
1.44 score on a scale
Standard Deviation 1.79
|
|
Determine if Slow-wave Disruption Alters Mood in Individuals With MDD
HAM-D following SWD
|
5.53 score on a scale
Standard Deviation 3.89
|
1.22 score on a scale
Standard Deviation 1.17
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Subjects With Major Depressive Disorder
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ineligible/Withdrew
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Control
n=20 participants at risk
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.
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.
|
Subjects With Major Depressive Disorder
n=33 participants at risk
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.
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.
|
Ineligible/Withdrew
n=11 participants at risk
Results are reported per Arm/Group, but data from participants who were ineligible or withdrew did not complete the study and therefore had no associated adverse events.
|
|---|---|---|---|
|
General disorders
Headache
|
5.0%
1/20 • Number of events 1 • 1 month
|
0.00%
0/33 • 1 month
|
0.00%
0/11 • 1 month
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place