Sleep and Light Interventions for Menopausal Depression
(SALI Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of California, San Diego
Must not be taking: Melatonin
Disqualifiers: Suicidal, Psychotic, Bipolar, Epilepsy, others
No Placebo Group
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.
12345Is 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.
35678How 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.
12345Eligibility 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
+2 more
Trial 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
Participant Groups
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.
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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of California San Diego Hillcrest Medical CenterSan Diego, CA
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Who Is Running the Clinical Trial?
University of California, San DiegoLead Sponsor
References
Sleep-light interventions that shift melatonin rhythms earlier improve perimenopausal and postmenopausal depression: preliminary findings. [2023]Testing the hypothesis that a sleep-light intervention, which phase-advances melatonin rhythms, will improve perimenopausal-postmenopausal (P-M; by follicle-stimulating hormone) depression.
Sleep, rhythms and women's mood. Part II. Menopause. [2021]This review summarizes studies of sleep and other biological rhythms in menopausal women with major depression compared with healthy control subjects. Where feasible, we focused on studies in women who met DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition) criteria for a major depressive episode (MDE) compared with matched normal control subjects and the Staging System for Reproductive Aging in Women (STRAW) criteria. The aim was to review supporting evidence for the hypothesis that a disruption of the normal temporal relationship between sleep and other biological rhythms, such as melatonin, cortisol, thyroid stimulating hormone (TSH) or prolactin, occur during the menopausal transition. As a result, depressive disorders occur in predisposed women. Treatment strategies, designed to correct these altered phase (timing) or amplitude abnormalities, thereby improve mood. Although there may be some common features to menopausal depression compared with other depressive disorders related to the reproductive cycle (e.g. premenstrual dysphoric disorder or postpartum major depression), such as increased morning melatonin secretion, a specific profile of sleep and biological rhythms may distinguish healthy from depressed women during menopause. Further work is needed to characterize more fully the particular abnormalities associated with well-defined menopausal depression in order to develop treatment strategies targeted more specifically to pathogenesis.
Depression During and After the Perimenopause: Impact of Hormones, Genetics, and Environmental Determinants of Disease. [2021]Vulnerability to depression is increased across the menopause transition and in the early years after the final menstrual period. Clinicians should systematically screen women in this age group; if depressive symptoms or disorder are present, treatment of depression should be initiated. Potential treatments include antidepressants for moderate to severe symptoms, psychotherapy to target psychological and interpersonal factors, and hormone therapy for women with first-onset major depressive disorder or elevated depressive symptoms and at low risk for adverse effects. Behavioral interventions can improve physical activity and sleep patterns.
Effects of light therapy on sleep, mood, and temperature in women with nonseasonal major depression. [2022]Research has supported the applicability and efficacy of light therapy in the treatment of nonseasonal depression. The investigators examined the effects of light therapy on sleep, core temperature, depressed mood, and perception of fatigue and energy in a sample of pre-menopausal and post-menopausal women diagnosed with nonseasonal, nonbipolar depression. Women were randomly assigned to either light therapy (n = 16) or placebo (n = 13) for a 28-day period. Pre and post measures of sleep and core temperature were collected. In addition, measures of depressed mood, fatigue, and energy were collected throughout the study period. Significant changes in depression and energy were found in the treatment group, but not in the placebo group. There was a significant reduction in the temperature mesor and less wake time during the first third of the sleep period in the treatment group but not in the placebo group. Light therapy yielded significant improvement in depression when compared with placebo intervention and core temperature mesor returned to normal. There was no significant phase shift, perhaps due in part to the absence of any baseline circadian phase disturbances. Relationships between temperature, sleep, depressed mood, fatigue, and energy variables offer potential directions for future research and clinical intervention.
A 1-week sleep and light intervention improves mood in premenstrual dysphoric disorder in association with shifting melatonin offset time earlier. [2023]To test the hypothesis that 1 week of combined sleep and light interventions (SALI), which phase-advance (shift earlier) melatonin circadian rhythms, improves mood significantly more than phase-delay (shift later) SALI. After a 2-month diagnostic evaluation for premenstrual dysphoric disorder (PMDD per DSM-5 criteria) in a university clinical research setting, 44 participants enrolled in baseline studies were randomized in the luteal phase at home to (A) a phase-advance intervention (PAI): 1 night of late-night wake therapy (LWT: sleep 9 pm-1 am) followed by 7 days of the morning (AM) bright white light (BWL), or (B) a phase-delay intervention (PDI): 1 night of early-night wake therapy (EWT: sleep 3-7 am) plus 7 days of the evening (PM) BWL. After a month of no intervention, participants underwent the alternate intervention. Outcome measures were mood, the melatonin metabolite, 6-sulfatoxymelatonin (6-SMT), and actigraphy (to assess protocol compliance). At baseline, atypical depression correlated positively with phase delay in 6-SMT offset time (r = .456, p = .038). PAI advanced 6-SMT offset from baseline more than PDI (p
Sleep, Hormones, and Circadian Rhythms throughout the Menstrual Cycle in Healthy Women and Women with Premenstrual Dysphoric Disorder. [2022]A relationship exists between the sleep-wake cycle and hormone secretion, which, in women, is further modulated by the menstrual cycle. This interaction can influence sleep across the menstrual cycle in healthy women and in women with premenstrual dysphoric disorder (PMDD), who experience specific alterations of circadian rhythms during their symptomatic luteal phase along with sleep disturbances during this time. This review will address the variation of sleep at different menstrual phases in healthy and PMDD women, as well as changes in circadian rhythms, with an emphasis on their relationship with female sex hormones. It will conclude with a brief discussion on nonpharmacological treatments of PMDD which use chronotherapeutic methods to realign circadian rhythms as a means of improving sleep and mood in these women.
Sleep EEG studies during early and late partial sleep deprivation in premenstrual dysphoric disorder and normal control subjects. [2019]In this study of 23 patients with premenstrual dysphoric disorder (PMDD) and 18 normal comparison (NC) subjects, we examined sleep EEG measures during baseline midfollicular (MF) and late luteal (LL) menstrual cycle phases and after early sleep deprivation (ESD), in which subjects slept from 03.00 to 07.00 h, and late sleep deprivation (LSD), in which subjects slept from 21.00 to 01.00 h. Each sleep deprivation night was followed by a night of recovery sleep (ESD-R, LSD-R) (sleep 22.30-06.30 h) and was administered in the late luteal phase of separate menstrual cycles. During baseline studies, sleep EEG measures differed significantly by menstrual cycle phase, but not group. Both PMDD and NC groups showed longer REM latencies and less REM sleep (minutes and percent) during the luteal compared with the follicular menstrual cycle phase. PMDD subjects, however, did not show sleep architecture changes similar to those of patients with major depressive disorders. Sleep quality was better during recovery nights of sleep in PMDD compared with NC subjects. REM sleep measures changed in association with clinical improvement in responders to sleep deprivation. Both early and late sleep deprivation may help to correct underlying circadian rhythm disturbances during sleep in PMDD, although differential sleep changes during ESD vs. LSD did not correlate with clinical response. Further sleep studies addressing additional circadian variables may serve to elucidate mechanisms mediating the therapeutic effects of sleep deprivation in PMDD.
Sleep deprivation in mood disorders. [2022]Growing clinical evidence in support of the efficacy and safety of sleep deprivation (SD), and its biological mechanisms of action suggest that this technique can now be included among the first-line antidepressant treatment strategies for mood disorders. SD targets the broadly defined depressive syndrome, and can be administered according to several different treatment schedules: total versus partial, single versus repeated, alone or combined with antidepressant drugs, mood stabilizers, or other chronotherapeutic techniques, such as light therapy and sleep phase advance. The present review focuses on clinical evidence about the place of SD in therapy, its indications, dosage and timing of the therapeutic wake, interactions with other treatments, precautions and contraindications, adverse reactions, mechanism of action, and comparative efficacy, with the aim of providing the clinical psychiatrist with an updated, concise guide to its application.