Treatment for Depression

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Depression+3 More
Eligibility
18 - 65
All Sexes
What conditions do you have?
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Study Summary

This trial will test whether an intervention that improves sleep patterns can also reduce depressive symptoms by improving emotion regulation brain function.

Eligible Conditions
  • Depression
  • Insomnia

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

4 Primary · 17 Secondary · Reporting Duration: Assessed at week 0 and week 11

Week 11
Change in Actigraph Number of Arousals as a Measure of Sleep Continuity
Change in Actigraph Sleep Efficiency (SE) as a Measure of Sleep Continuity
Change in Actigraph Sleep Onset Latency (SOL) as a Measure of Sleep Continuity
Change in Actigraph Total Sleep Time (TST) as a Measure of Sleep Continuity
Change in Actigraph Wake After Sleep Onset (WASO) as a Measure of Sleep Continuity
Change in Beck Anxiety Inventory
Change in Beck Depression Inventory
Change in Columbia Suicide Severity Rating Scale
Brain
Change in Emotion Regulation Network brain connectivity as assessed by functional magnetic resonance imaging
Change in Insomnia Severity Index (ISI) Scale Score
Change in PSG Number of Arousals as a Measure of Sleep Architecture
Change in PSG Sleep Efficiency
Change in PSG Sleep Efficiency (SE) as a Measure of Sleep Architecture
Change in PSG Sleep Onset Latency (SOL) as a Measure of Sleep Architecture
Change in PSG Total Sleep Time (TST) as a Measure of Sleep Architecture
Change in PSG Wake After Sleep Onset (WASO) as a Measure of Sleep Architecture
Change in Respiratory Sinus Arrhythmia (RSA)- measured by PSG
Change in Sleep Physiology measured by PSG
Change in Social and Occupational Functioning Assessment Scale (SOFAS)
Change in World Health Organization quality of life assessment (WHOQoL)

Trial Safety

Safety Progress

1 of 3

Trial Design

0 Treatment Group

70 Total Participants · 0 Treatment Group

Primary Treatment: Treatment · No Placebo Group · N/A

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: assessed at week 0 and week 11

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,148 Previous Clinical Trials
35,678,934 Total Patients Enrolled
96 Trials studying Depression
92,525 Patients Enrolled for Depression
Andrea Goldstein-Piekarski, PhDPrincipal Investigator - Stanford University
Stanford University
2 Previous Clinical Trials
199 Total Patients Enrolled

Eligibility Criteria

Age 18 - 65 · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Many people complain of not getting enough sleep, or of poor sleep quality, for at least three months
People who complain of depression (score of 14 or higher on the BDI questionnaire) and don't seem to be at risk for suicide are assessed with the CSSRS tool.
and Spanish She is fluent in both English and Spanish.
significantly improved mean reductions in pain intensity from baseline to week 4 Drinking ≤ 3 cups of coffee or other caffeinated drinks prior to lunch every day for at least 3 weeks before treatment significantly improved pain intensity reductions from baseline to week 4.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 21st, 2021

Last Reviewed: October 11th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.