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Experimental Group for Depression (SALI Trial)

N/A
Waitlist Available
Led By Barbara Parry, M.D.
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Perimenopausal women with irregular menstrual cycles for at least 3 months
* Above age 18
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and after completing two-week intervention; sustained at two weeks post intervention completion through three months post intervention completion.
Awards & highlights
No Placebo-Only Group

Summary

The goal of this clinical trial is to learn more about mood, sleep, and activity during menopause. The main question it aims to answer is: can mood and sleep dysfunction in menopause be improved by resetting misaligned circadian rhythm through one night of strategic sleep timing adjustment and two weeks of exposure to bright light at a certain time of day? Researchers will compare sleep timing (earlier vs. later) and bright white light exposure (morning or evening) to investigate the effect of melatonin levels on mood, sleep, and activity. Participants will 1) submit urine samples to measure melatonin levels, 2) be assigned to advance or delay their sleep for one night, 3) sit in front of a light box for 30 minutes per day (morning or evening) for 14 days, 4) complete questionnaires about their mood and sleep, and 5) wear a device that will measure their activity.

Eligible Conditions
  • Menopausal Depression
  • Depression

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and after completing two-week intervention; sustained at two weeks post intervention completion through three months post intervention completion.
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and after completing two-week intervention; sustained at two weeks post intervention completion through three months post intervention completion. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Objective Measures of Physical Activity
Objective Measures of Sleep
Patient Health Questionnaire (PHQ-9)
+3 more

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: Experimental GroupExperimental Treatment1 Intervention
Participants assigned to the experimental condition.
Group II: Active Comparator GroupActive Control1 Intervention
Participants assigned to the active comparator condition.

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Who is running the clinical trial?

University of California, San DiegoLead Sponsor
1,180 Previous Clinical Trials
1,574,961 Total Patients Enrolled
37 Trials studying Depression
59,352 Patients Enrolled for Depression
Barbara Parry, M.D.Principal InvestigatorUniversity of California, San Diego
~80 spots leftby Oct 2028