DepressionSALINCT06678880
Sleep and Light Intervention (SALI) for Menopausal Mood Dysfunction
A study testing Phase Advanced Intervention (PAI) and Phase Delay Intervention (PDI) in people with Depression and Depression During the Menopausal Transition, run by University of California, San Diego at 1 site in United States.
Trial summary
Participants must live in San Diego County The purpose of this study is to learn more about an experimental Sleep \& Light Intervention (SALI) for menopausal mood changes or depression. Read more about this study
- Who is it for?
- Ages 45 to 75 years, women only
- Conditions the study is for
- Depression, Depression During the Menopausal Transition, Menopausal Depression
- What is being tested?
- Phase Advanced Intervention (PAI) and Phase Delay Intervention (PDI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2025to 28 Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged 45-75 years old
- Experiencing significant down, sad or hopeless feelings that are affecting their daily life
- These mood changes started or got worse during the menopause transition
- Irregular or no menstrual cycle for at least 6 months
- Non-smoking
- Located in San Diego County
Who cannot join
- Untreated sleep apnea
- Migraine headaches that are triggered or worsened by bright light
- Currently suicidal or psychotic
- History of bipolar disorder
- A medical condition or job where fatigue or changes in sleep schedule could be unsafe
- Planning to start, stop, or change medications in the next 4 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California San Diego Hillcrest Medical Center
San Diego, California, 92103
Barbara L Parry, M.D., (619) 980-1942, bparry@ucsd.edu
David H Sommerfeld, Ph.D., (858) 472-9397, dsommerfeld@health.ucsd.edu
About this study
Official title: Chronobiological Basis of Depression During the Menopause Transition
Participants must live in San Diego County
The purpose of this study is to learn more about an experimental Sleep \& Light Intervention (SALI) for menopausal mood changes or depression. Researchers want to find out whether adjusting the body's internal clock-which helps regulate sleep, hormones, mood, and energy- can improve symptoms such as depression, poor sleep, and low energy during menopause.
Read the detailed description
Our bodies naturally follow a 24-hour internal clock that helps regulate sleep, hormones, mood, and energy. During menopause, hormonal changes can disrupt the timing of this internal clock, which may contribute to mood changes, sleep problems, and low energy.
Participants will be asked to change their sleep timing for one night and use bright light at specific times of day for two weeks. In previous studies, some women experienced improvements in mood within days to weeks. SALI does not use medication and has few side effects.
Participants must live in San Diego County. Interested individuals will first complete a screening process to help determine whether this study is a good match for them and whether participation would be appropriate and safe. The screening includes questionnaires and interviews about health, mood, sleep, and mental health history. Not everyone who is screened will qualify to participate.
Study participation is approximately 4 ½ months, and includes:
- 4 weeks of wearing an activity/light wrist sensor
- 2 overnight urine collections to measure melatonin, the best measure of human circadian rhythms, and a hormone that helps regulate the timing of sleep
- 1 night where the timing and duration of your sleep will be adjusted
- 2 weeks of daily light box usage (30 minutes per day at a specified time) and daily surveys to track mood \& side effects
- Regularly scheduled Zoom interviews \& online surveys to monitor your mood \& sleep before and after SALI
All study activities can be done from the comfort of your home. Researchers hope this work will lead to new ways to improve mood and sleep during menopause and help identify treatments that can be tailored to each person's biological rhythms.
This is a research study, not a clinical treatment. Participation is confidential and voluntary. Participants may or may not benefit directly from participating. To receive full compensation, participants are required to complete study tasks on scheduled days.
- Being tested
- Phase Advanced Intervention (PAI), Phase Delay Intervention (PDI)
- Keywords
- Menopause, depression, sleep and light intervention, melatonin, circadian rhythm, Chronobiology
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phase Advanced Intervention (PAI)Behavioural
Phase-advanced restricted sleep (i.e., sleep 9pm-1am only) for 1 night, followed by morning bright white light for 30 min/day for 2 weeks.
Phase Delay Intervention (PDI)Behavioural
Phase-delayed restricted sleep (i.e., sleep 3am to 7am only) for 1 night, followed by evening bright white light for 30 min/day for 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Participants assigned to the experimental condition. Receives: Behavioral: Phase Advanced Intervention (PAI) |
| Group 2 | Active comparator | Participants assigned to the active comparator condition. Receives: Behavioral: Phase Delay Intervention (PDI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary 6-sulfatoxymelatonin (6-SMT)
Collected to measure melatonin, a hormone that helps regulate your sleep and body clocks.
Measured: Urine is collected at baseline and after completing two-week intervention.
Structured Interview Guide for the Hamilton Rating Depression Scale with Atypical Depression Supplement (SIGH-ADS)
A clinician-conducted interview that asks about symptoms of depression, including mood, sleep, appetite, energy, and other emotional and physical symptoms.
Measured: Completed at baseline and after completing two-week intervention.
Patient Health Questionnaire (PHQ-9)
A brief questionnaire that asks about common symptoms of depression, such as mood, sleep, energy, appetite, and concentration.
Measured: Completed at baseline and after completing two-week intervention.
Sleep Quality Rating (SQR)
A brief questionnaire to rate how well you have been sleeping and whether you have experienced any sleep-related problems.
Measured: Completed at baseline and after completing two-week intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start11 Mar 2025
- Primary completionDec 2028 (estimated)
- Study completion28 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barbara L. Parry, M.D., University of California, San Diego
- Investigators
- Barbara Parry, M.D., Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06678880
- Sponsor's protocol ID
- MH134120
- Acronym
- SALI
- Status last verified
- Jan 2026
- First submitted
- 30 Oct 2024
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to directly share individual participant data (IPD) with other investigators. If such data is requested, the investigators will consider each request individually to determine whether sharing of IPD is appropriate or feasible. However, the investigators will be providing de-identified data to the National Institution for Mental Health Data Archive (NDA) throughout the duration of the study as required by NIH. This data will be available to other investigators after the conclusion of the study per the guidelines and restrictions established by the NDA.
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronobiological Basis of Depression During the Menopause Transition
- ClinicalTrials.gov ID
- NCT06678880
- Acronym / sponsor ID
- SALI / MH134120
- Keywords
- Menopause, depression, sleep and light intervention, melatonin, circadian rhythm, Chronobiology
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 11 Mar 2025 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- 28 Feb 2029 (estimated)
- First posted
- 7 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Participants must live in San Diego County
The purpose of this study is to learn more about an experimental Sleep \& Light Intervention (SALI) for menopausal mood changes or depression. Researchers want to find out whether adjusting the body's internal clock-which helps regulate sleep, hormones, mood, and energy- can improve symptoms such as depression, poor sleep, and low energy during menopause.
Detailed description
Our bodies naturally follow a 24-hour internal clock that helps regulate sleep, hormones, mood, and energy. During menopause, hormonal changes can disrupt the timing of this internal clock, which may contribute to mood changes, sleep problems, and low energy.
Participants will be asked to change their sleep timing for one night and use bright light at specific times of day for two weeks. In previous studies, some women experienced improvements in mood within days to weeks. SALI does not use medication and has few side effects.
Participants must live in San Diego County. Interested individuals will first complete a screening process to help determine whether this study is a good match for them and whether participation would be appropriate and safe. The screening includes questionnaires and interviews about health, mood, sleep, and mental health history. Not everyone who is screened will qualify to participate.
Study participation is approximately 4 ½ months, and includes:
- 4 weeks of wearing an activity/light wrist sensor
- 2 overnight urine collections to measure melatonin, the best measure of human circadian rhythms, and a hormone that helps regulate the timing of sleep
- 1 night where the timing and duration of your sleep will be adjusted
- 2 weeks of daily light box usage (30 minutes per day at a specified time) and daily surveys to track mood \& side effects
- Regularly scheduled Zoom interviews \& online surveys to monitor your mood \& sleep before and after SALI
All study activities can be done from the comfort of your home. Researchers hope this work will lead to new ways to improve mood and sleep during menopause and help identify treatments that can be tailored to each person's biological rhythms.
This is a research study, not a clinical treatment. Participation is confidential and voluntary. Participants may or may not benefit directly from participating. To receive full compensation, participants are required to complete study tasks on scheduled days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Behavioral: Phase Advanced Intervention (PAI)Participants assigned to the experimental condition. |
| Group 2 | Active comparator | Behavioral: Phase Delay Intervention (PDI)Participants assigned to the active comparator condition. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Women aged 45-75 years old
- Experiencing significant down, sad or hopeless feelings that are affecting their daily life
- These mood changes started or got worse during the menopause transition
- Irregular or no menstrual cycle for at least 6 months
- Non-smoking
Key exclusion criteria (6 listed)
- Untreated sleep apnea
- Migraine headaches that are triggered or worsened by bright light
- Currently suicidal or psychotic
- History of bipolar disorder
- A medical condition or job where fatigue or changes in sleep schedule could be unsafe
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phase Advanced Intervention (PAI)Phase-advanced restricted sleep (i.e., sleep 9pm-1am only) for 1 night, followed by morning bright white light for 30 min/day for 2 weeks. | Behavioural | Group 1 |
| Phase Delay Intervention (PDI)Phase-delayed restricted sleep (i.e., sleep 3am to 7am only) for 1 night, followed by evening bright white light for 30 min/day for 2 weeks. | Behavioural | Group 2 |
Primary outcome
Urinary 6-sulfatoxymelatonin (6-SMT)
Time frame: Urine is collected at baseline and after completing two-week intervention.
Collected to measure melatonin, a hormone that helps regulate your sleep and body clocks.
Structured Interview Guide for the Hamilton Rating Depression Scale with Atypical Depression Supplement (SIGH-ADS)
Time frame: Completed at baseline and after completing two-week intervention.
A clinician-conducted interview that asks about symptoms of depression, including mood, sleep, appetite, energy, and other emotional and physical symptoms.
Patient Health Questionnaire (PHQ-9)
Time frame: Completed at baseline and after completing two-week intervention.
A brief questionnaire that asks about common symptoms of depression, such as mood, sleep, energy, appetite, and concentration.
Sleep Quality Rating (SQR)
Time frame: Completed at baseline and after completing two-week intervention.
A brief questionnaire to rate how well you have been sleeping and whether you have experienced any sleep-related problems.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Individual participant dataSharing planned: No. There is not a plan to directly share individual participant data (IPD) with other investigators. If such data is requested, the investigators will consider each request individually to determine whether sharing of IPD is appropriate or feasible. However, the investigators will be providing de-identified data to the National Institution for Mental Health Data Archive (NDA) throughout the duration of the study as required by NIH. This data will be available to other investigators after the conclusion of the study per the guidelines and restrictions established by the NDA.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Barbara Parry, M.D. principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phase Advanced Intervention (PAI) and Phase Delay Intervention (PDI) in people with Depression and Depression During the Menopausal Transition, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer A Perrott, MSW ((407) 619-9441, jperrott@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary 6-sulfatoxymelatonin (6-SMT) (time frame: Urine is collected at baseline and after completing two-week intervention.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.