Sleep and Light Interventions for Menopausal Depression

(SALI Trial)

Overseen By David Sommerfeld, Ph.D.

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of California, San Diego

Must not be taking: Melatonin

Disqualifiers: Suicidal, Psychotic, Bipolar, Epilepsy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if adjusting sleep patterns and exposure to bright light can improve mood and sleep issues during menopause. Researchers will test whether changing sleep timing for one night and using a light box for 30 minutes daily over two weeks can positively affect mood and activity levels. Women with irregular periods for at least three months and moderate depression symptoms might be suitable for this study. Participants will provide urine samples to check melatonin levels, try different sleep timings through Phase Advanced Intervention (PAI) or Phase Delay Intervention (PDI), and complete mood and sleep questionnaires. As an unphased trial, this study offers a unique opportunity to explore innovative solutions for menopausal symptoms.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are starting new medications that affect sleep or mood, like melatonin, you may not be eligible to participate.

What prior data suggests that these sleep and light interventions are safe for menopausal women?

Research shows that the treatments tested in the clinical trial, which involve changing sleep times and exposure to bright light, are generally easy for people to handle.

For the Phase Advanced Intervention (PAI), earlier studies have found that moving sleep earlier can improve mood without causing major side effects, indicating the treatment is likely safe for participants.

The Phase Delay Intervention (PDI) involves going to sleep later. Past research has shown that this can also help improve mood symptoms, with no serious side effects reported in these studies.

Overall, the treatments involve natural changes to sleep and light exposure, which are usually safe and non-invasive. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Sleep and Light Interventions for Menopausal Depression because they offer a non-drug approach that could be a game-changer for managing this condition. Unlike standard treatments like antidepressants or hormone replacement therapy, which often have side effects, these interventions aim to adjust sleep patterns and light exposure to improve mood naturally. The Phase Advanced Intervention (PAI) and Phase Delay Intervention (PDI) work by resetting the body's internal clock, which could lead to improvements in sleep quality and mood. This approach is innovative because it targets the body's natural rhythms, potentially offering a safer and more holistic alternative to traditional treatments.

What evidence suggests that this trial's interventions could be effective for menopausal depression?

Research shows that changing sleep schedules and using bright light can improve mood and sleep during menopause. Studies have found that when the body's internal clock, or circadian rhythm, is out of sync, mood and sleep can suffer. Adjusting sleep times and using bright light at specific times can reset this internal clock. In this trial, participants will join either the Phase Advanced Intervention (PAI) or the Phase Delay Intervention (PDI) groups. Early findings suggest that both PAI and PDI effectively enhance mood and sleep. These methods aim to reduce depression and anxiety, common during menopause. Resetting the circadian rhythm may lead to better mental health and overall well-being. ^{2 5 6 7 8}

Who Is on the Research Team?

Barbara Parry, M.D.

Principal Investigator

University of California, San Diego

Are You a Good Fit for This Trial?

This trial is for women experiencing mood and sleep issues during menopause. Participants will need to adjust their sleep schedule for one night, use a light box daily for two weeks, provide urine samples, fill out questionnaires on mood and sleep, and wear an activity tracker.

Inclusion Criteria

I am over 18 years old.

I am experiencing moderate to severe depression.

I am a perimenopausal woman with irregular periods for the last 3 months.

Exclusion Criteria

Actively suicidal or psychotic

Women whose body mass index (BMI) exceeds the NIH criteria of <18 or >30

History of bipolar disorder

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants undergo a one-night sleep timing adjustment followed by two weeks of bright light exposure

2 weeks

Daily at-home sessions

Follow-up

Participants are monitored for changes in mood, sleep, and activity post-intervention

3 months

Continuous monitoring with periodic assessments

What Are the Treatments Tested in This Trial?

Interventions

• Phase Advanced Intervention (PAI)
• Phase Delay Intervention (PDI)

Trial Overview

Researchers are testing if adjusting the timing of sleep (earlier or later) combined with exposure to bright white light in the morning or evening can improve melatonin levels, mood, and sleep patterns in menopausal women.

How Is the Trial Designed?

Group I: Experimental Group Experimental Treatment 1 Intervention

Participants assigned to the experimental condition.

Group II: Active Comparator Group Active Control 1 Intervention

Participants assigned to the active comparator condition.

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

Published Research Related to This Trial

A sleep-light intervention that phase-advances melatonin rhythms significantly improved mood in perimenopausal-postmenopausal women with depression, with a 70% improvement observed after 8 weeks.

The study involved 17 participants, showing that advancing melatonin secretion correlated positively with mood enhancement, suggesting this nonpharmaceutical approach could be a safe and effective treatment for P-M depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep-light interventions that shift melatonin rhythms earlier improve perimenopausal and postmenopausal depression: preliminary findings. Parry, BL., Meliska, CJ., Sorenson, DL., et al.[2023]

The sleep-wake cycle in women is influenced by both hormone secretion and the menstrual cycle, leading to variations in sleep quality across different menstrual phases, particularly in women with premenstrual dysphoric disorder (PMDD).

Nonpharmacological treatments that focus on realigning circadian rhythms, such as chronotherapy, may help improve sleep and mood in women suffering from PMDD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep, Hormones, and Circadian Rhythms throughout the Menstrual Cycle in Healthy Women and Women with Premenstrual Dysphoric Disorder. Shechter, A., Boivin, DB.[2022]

Light therapy significantly improved symptoms of depression and increased energy levels in pre-menopausal and post-menopausal women with nonseasonal depression, as evidenced by a 28-day study involving 29 participants (16 in the treatment group and 13 in the placebo group).

The treatment also normalized core temperature patterns and reduced wake time during the initial part of the sleep period, indicating potential physiological benefits alongside mood improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of light therapy on sleep, mood, and temperature in women with nonseasonal major depression. McEnany, GW., Lee, KA.[2022]

In a study of 23 patients with premenstrual dysphoric disorder (PMDD) and 18 normal comparison subjects, sleep EEG measures showed significant differences based on menstrual cycle phases, with both groups experiencing less REM sleep during the luteal phase compared to the follicular phase.

Recovery sleep after sleep deprivation improved sleep quality in PMDD patients compared to normal subjects, suggesting that sleep deprivation may help address circadian rhythm disturbances in PMDD, although the specific sleep changes did not directly correlate with clinical improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep EEG studies during early and late partial sleep deprivation in premenstrual dysphoric disorder and normal control subjects. Parry, BL., Mostofi, N., LeVeau, B., et al.[2019]

Sleep deprivation (SD) is emerging as a safe and effective first-line treatment for mood disorders, supported by growing clinical evidence and biological mechanisms of action.

SD can be administered in various ways—total or partial, single or repeated sessions—and can be combined with other treatments like antidepressants and light therapy, making it a versatile option for clinicians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep deprivation in mood disorders. Benedetti, F., Colombo, C.[2022]

A 1-week phase-advance intervention combining late-night wake therapy and morning bright light significantly improved mood in participants with premenstrual dysphoric disorder (PMDD) compared to a phase-delay intervention, as evidenced by better mood scores and changes in melatonin levels.

The phase-advance intervention was found to be a safe, effective, and non-pharmacological treatment option for PMDD, demonstrating rapid mood improvement associated with shifts in melatonin circadian rhythms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A 1-week sleep and light intervention improves mood in premenstrual dysphoric disorder in association with shifting melatonin offset time earlier. Parry, BL., Meliska, CJ., Martinez, LF., et al.[2023]

Women going through menopause and shortly after are at a higher risk for depression, so it's important for healthcare providers to regularly check for depressive symptoms in this group.

Effective treatments for depression in menopausal women include antidepressants for more severe cases, psychotherapy for psychological support, hormone therapy for those with specific conditions, and behavioral interventions to enhance physical activity and sleep.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Depression During and After the Perimenopause: Impact of Hormones, Genetics, and Environmental Determinants of Disease. Bromberger, JT., Epperson, CN.[2021]

Menopausal women with major depression show disruptions in sleep and biological rhythms, such as melatonin and cortisol levels, compared to healthy women, suggesting these disruptions may contribute to depressive disorders during menopause.

Targeted treatment strategies that correct these timing and amplitude abnormalities in biological rhythms could potentially improve mood in affected women, highlighting the need for further research to develop specific interventions for menopausal depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep, rhythms and women's mood. Part II. Menopause. Parry, BL., Fernando Martínez, L., Maurer, EL., et al.[2021]

Citations

1.

clinicaltrials.ucsd.edu

clinicaltrials.ucsd.edu/trial/NCT06678880

Correcting Misaligned Circadian Rhythms With Sleep and ...

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:

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10917984/

Stress, depression, and anxiety: psychological complaints ...

This study aimed to explore (i) the relationship between psychological complaints (depression, anxiety, poor memory) across different menopausal stages

3.

jognn.org

jognn.org/article/S0884-2175(24)00349-6/fulltext

Associations Between Menopause and Depression

Menopause is a process of hormonal changes that typically starts in a woman's mid- to late 40s and is associated with an increased risk of depression.

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4143563/

Reducing depression during the menopausal transition

An effective intervention should decrease the prevalence of depression amongst these women from 14% to 6%, which would represent an absolute risk reduction of 8 ...

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT02234362

NCT02234362 | Vortioxetine for Menopausal Depression

The broad goal of this study was to examine the efficacy and tolerability of vortioxetine (flexible dose) for the treatment of major depressive disorder (MDD)

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10524957/

Sleep + Light Interventions that Shift Melatonin Rhythms ...

These preliminary findings reveal significantly phase-delayed melatonin rhythms in DP vs NC PM women. Phase-advancing melatonin rhythms improves mood.

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11794376/

Association of Depression with Age at Natural Menopause

In this cross-sectional study, the severity of depression in American women was positively correlated with the risk of early menopause.

8.

journals.lww.com

journals.lww.com/menopausejournal/fulltext/2025/06000/treating_moderate_to_severe_menopausal_vasomotor.2.aspx

Treating moderate to severe menopausal vasomotor ...

Menopausal hormone therapy and health outcomes during the intervention and extended poststopping phases of the Women's Health Initiative randomized trials.