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Slow-wave disruption for Depression (SWIP Trial)
N/A
Waitlist Available
Led By Jennifer Goldschmied, PhD
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age: 25-50
Normal cognition
Must not have
Lifetime history of electroconvulsive therapy
No history of depression for the control group
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to a month
Awards & highlights
No Placebo-Only Group
Summary
This trial will investigate whether a new treatment for depression, which involves manipulating sleep, can help improve mood by increasing synaptic strength.
Who is the study for?
This trial is for adults aged 25-50 with current depression, normal cognition, and stable sleep-wake cycles. Participants must be right-handed, English-speaking, with normal or corrected vision/hearing. Excluded are those with certain mental health histories, implanted devices, recent extensive travel, pregnancy in women, or unwillingness to avoid alcohol/caffeine.
What is being tested?
The study tests whether disrupting slow-wave activity (SWA) during sleep can improve synaptic plasticity and mood in people with major depressive disorder (MDD). It explores the idea that enhancing SWA might counteract deficits in synaptic strength linked to depression.
What are the potential side effects?
While specific side effects are not detailed here, interventions involving SWA disruption may potentially affect sleep patterns and quality. Any changes to brain activity could also influence mood and cognitive functions temporarily.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 25 and 50 years old.
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My thinking and memory skills are normal.
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My vision and hearing are normal, or corrected to be normal.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have never undergone electroconvulsive therapy.
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I have never been diagnosed with depression.
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I have a sleep disorder that is not insomnia.
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I have had a stroke, epilepsy, brain aneurysm clip, or a head injury that caused me to lose consciousness.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to a month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to a month
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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
Secondary study objectives
Determine if slow-wave disruption alters mood in individuals with MDD
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Subjects with Major Depressive DisorderExperimental Treatment1 Intervention
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.
Group II: ControlActive Control1 Intervention
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.
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Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,077 Previous Clinical Trials
42,720,009 Total Patients Enrolled
70 Trials studying Depression
29,919 Patients Enrolled for Depression
Jennifer Goldschmied, PhDPrincipal InvestigatorUniversity of Pennsylvania
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have never undergone electroconvulsive therapy.I am between 25 and 50 years old.My thinking and memory skills are normal.I have never been diagnosed with depression.You have a history of certain mental health conditions like bipolar disorder, schizophrenia, or memory-related disorders.I have a sleep disorder that is not insomnia.I have a medical condition now or had one in the past.You are not willing to stop drinking alcohol or consuming caffeine while participating in the study.My vision and hearing are normal, or corrected to be normal.I have had a stroke, epilepsy, brain aneurysm clip, or a head injury that caused me to lose consciousness.
Research Study Groups:
This trial has the following groups:- Group 1: Subjects with Major Depressive Disorder
- Group 2: Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Depression Patient Testimony for trial: Trial Name: NCT04150718 — N/A
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