N/A
N=77
Role of Slow-wave Activity and Plasticity in MDD
Depression
Bottom Line
View on ClinicalTrials.gov: NCT04150718 ↗Enrolled (actual)
77
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcome: Primary: Compare Indices of Net Synaptic Strength (Transcranial Magnetic Stimulation Evoked Potentials) in Individuals With MDD to Healthy Controls — 195.07; 179.16; 323.22; 212.73 millivolts (mV) — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- slow-wave disruption (Behavioral)
- Age
- Adult · 25+ yrs
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Compare Indices of Net Synaptic Strength (Transcranial Magnetic Stimulation Evoked Potentials) in Individuals With MDD to Healthy Controls |
195.07; 179.16; 323.22; 212.73 | <0.05 sig |
| PRIMARY Compare Markers Associated With Plasticity (BDNF) in Individuals With MDD to Healthy Controls |
1599.80; 1738.32; 2839.79; 2860.74 | <0.05 sig |
| SECONDARY Determine if Slow-wave Disruption Alters Mood in Individuals With MDD |
5.25; 1.44; 5.53; 1.22 | <0.001 sig |
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.
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
Data sourced from ClinicalTrials.gov (NCT04150718). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.