Improving mood and sleep in menopausal women using light and sleep adjustments
Chronobiological Basis of Depression During the Menopause Transition
NA · University of California, San Diego · NCT06678880
This study is testing if adjusting sleep schedules and using bright light can help improve mood and sleep for women going through menopause who are feeling depressed.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of California, San Diego (other) |
| Locations | 1 site (San Diego, California) |
| Trial ID | NCT06678880 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates whether correcting misaligned circadian rhythms can improve mood and sleep dysfunction in perimenopausal women experiencing depression. Participants will undergo a one-night sleep timing adjustment followed by two weeks of bright light exposure at specific times of the day. The study will measure melatonin levels through urine samples and assess mood and sleep through questionnaires and activity tracking devices. The goal is to determine if these interventions can effectively enhance mental health and sleep quality during menopause.
Who should consider this trial
Good fit: Ideal candidates are perimenopausal women over 18 years old who have irregular menstrual cycles and are experiencing moderate to severe depression.
Not a fit: Patients with a history of bipolar disorder, actively suicidal tendencies, or those for whom sleep restriction is contraindicated may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life for menopausal women suffering from depression and sleep issues.
How similar studies have performed: Previous studies have shown promising results in using light and sleep interventions to improve mood and sleep in similar populations, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Perimenopausal women with irregular menstrual cycles for at least 3 months * Above age 18 * Experiencing at least moderate depression symptoms (i.e., score of at least 10 on PHQ-9) Exclusion Criteria: * Actively suicidal or psychotic * History of bipolar disorder * Staring new medications that would affect outcome measures (e.g., melatonin) * Those in whom sleep restriction would be ill-advised (e.g., patients with epilepsy or those with occupations whose safety would be compromised). * Women whose body mass index (BMI) exceeds the NIH criteria of \<18 or \> than 30
Where this trial is running
San Diego, California
- University of California San Diego Hillcrest Medical Center — San Diego, California, United States (RECRUITING)
Study contacts
- Principal investigator: Barbara Parry, M.D. — University of California, San Diego
- Study coordinator: Jennifer A Perrott, MSW
- Email: jperrott@health.ucsd.edu
- Phone: (407) 619-9441
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Depression, Depression During the Menopausal Transition, Menopausal Depression, Menopause, depression, sleep and light intervention, melatonin, circadian rhythm