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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment for menopausal depression?

Research suggests that sleep-light interventions, which adjust the timing of melatonin (a hormone that regulates sleep) rhythms, can improve mood in menopausal women with depression. Additionally, light therapy has been shown to effectively reduce depression symptoms in women with nonseasonal depression, indicating potential benefits for menopausal depression as well. ^{1 2 3 4 5}

Is the sleep and light intervention safe for humans?

Research suggests that sleep and light interventions, including sleep deprivation and light therapy, are generally safe for humans and have been used as treatments for mood disorders. These interventions have been studied in various conditions and are considered safe when administered properly. ^{3 5 6 7 8}

How does the Sleep and Light Interventions treatment for menopausal depression differ from other treatments?

This treatment is unique because it uses sleep and light interventions to shift melatonin rhythms earlier, which can improve mood in menopausal depression. Unlike traditional treatments like antidepressants or hormone therapy, this approach targets the timing of biological rhythms to address mood symptoms. ^{1 2 3 4 5}

Research Team

Barbara Parry, M.D.

Principal Investigator

University of California, San Diego

Eligibility Criteria

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

I am over 18 years old.

I am experiencing moderate to severe depression.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Sleep-light interventions that shift melatonin rhythms earlier improve perimenopausal and postmenopausal depression: preliminary findings. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Sleep, rhythms and women's mood. Part II. Menopause. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

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

4. England pubmed.ncbi.nlm.nih.gov

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

5. Austria 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. [2023]

6. Egypt pubmed.ncbi.nlm.nih.gov

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

7. Ireland pubmed.ncbi.nlm.nih.gov

Sleep EEG studies during early and late partial sleep deprivation in premenstrual dysphoric disorder and normal control subjects. [2019]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Sleep deprivation in mood disorders. [2022]