DepressionEarly Phase 1SHINENCT02270619
Sleep Health, Inflammation, and Emotion Study
A Early Phase 1 study testing Endotoxin, Partial sleep deprivation and Uninterrupted sleep in people with Depression, run by University of California, Los Angeles at 1 site in United States.
Trial summary
Late-life depression is a major public health burden due to its high prevalence and associated morbidity, suicide risk, functional decline, and mortality. Unfortunately, current antidepressant therapies have limited effectiveness; hence, biologically plausible models for new treatments are being pursued. Read more about this study
- Who is it for?
- Ages 60 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- Endotoxin, Partial sleep deprivation and Uninterrupted sleep
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 95 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Jan 2021
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 60 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- to be in good general health
- to be female
- to be aged 60 to 80 years
Who cannot join
- presence of chronic mental or physical illnesses
- history of allergies, auto-immune, liver, or other chronic diseases
- current use of prescription medications such as steroids, non-steroid anti-inflammatory drugs, immune modifying drugs, opioid analgesics, and psychotropic medications
- current sleep disorders such as insomnia or sleep apnea
- nightshift work or time zone shifts (> 3 hours) within the previous 6 weeks
- an Axis I psychiatric disorder as determined by the Research Version of the Structured Clinical Interview for DSM-5 (SCID-5-RV) including a current or within 1 year prior-to-study history of major depressive disorder (a history of depression 1 or more years prior to the study is not an exclusion criterion, which will be considered for a pre-planned sensitivity analysis, however, any prior depressive episode severe enough to have involved suicidal ideation or required an inpatient psychiatric admission is an exclusion criterion)
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- prior or current suicidal ideation assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)
- current depressive symptoms assessed by the Patient Health Questionnaire (PHQ-9) (≥ 5)
- sleep disorders identified by the SCID and the Duke Structured Interview for Sleep Disorders (DSISD)
- sleep disturbance defined by the Pittsburgh Sleep Quality Index (PSQI) (≥ 5)
- a positive screen for sleep apnea using the Berlin Sleep Apnea Questionnaire
- excessive caffeine use (>600 mg/day)
- BMI > 35 due to the effects of obesity on cytokine activity and risk for sleep disordered breathing
- evidence of recreational drug use from urine test
- any abnormalities on screening laboratory tests.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA Cousins Center for Psychoneuroimmunology
Los Angeles, California, 90095
About this study
Official title: Sleep Loss as a Vulnerability Factor for Inflammation Induced Depressive Symptoms in Older Women
Late-life depression is a major public health burden due to its high prevalence and associated morbidity, suicide risk, functional decline, and mortality. Unfortunately, current antidepressant therapies have limited effectiveness; hence, biologically plausible models for new treatments are being pursued. Systemic inflammation is hypothesized to play an important role on the onset and perpetuation of depression, especially in older women. Aging processes involve a heightened inflammatory state, and both inflammatory disorders and depression are more prevalent in women than men. However, increased systemic inflammation does not necessarily lead to depression in all women. Even when robust systemic inflammation is experimentally induced (e.g. endotoxin administration), largely variable increases in depressive symptoms are found. Defining the factors that account for this variability may identify individuals at risk of developing depression when exposed to heightened inflammatory states such as aging, obesity, and chronic disease, and informs future translational studies of depression prevention. In particular, the role of sleep disturbance in explaining this variability requires further attention because it is an independent risk factor for depression and heightens systemic inflammation by increasing the production of proinflammatory cytokines. The investigators have also discovered that women, but not men, who report sleep disturbance including short sleep duration experience significantly more depressive symptoms in response to an inflammatory challenge than women without sleep disturbance. Thus, it is hypothesized that sleep loss is a vulnerability factor for inflammation-induced depressive symptoms in women. However, to date, no experimental approach has been used to evaluate the role of sleep loss on inflammation-induced depressive symptoms. This proposal aims to examine this hypothesis by partial sleep deprivation (PSD) followed by endotoxin challenge in older women. It also aims to explore genomic and socio- emotional mechanisms underlying the association between sleep loss and depressive symptoms. In a randomized controlled factorial design, 80 healthy female volunteers aged 60 to 80 will be randomly assigned to one of 4 arms: 1) uninterrupted sleep followed by placebo; 2) uninterrupted sleep followed by endotoxin; 3) PSD followed by placebo; or 4) PSD followed by endotoxin. Subjects will be administered placebo or endotoxin in the morning after PSD or uninterrupted sleep. Depressive symptoms will be repeatedly assessed over 6 hours after placebo or endotoxin administration.
- Conditions
- Depression
- Being tested
- Endotoxin, Partial sleep deprivation, Placebo, Uninterrupted sleep
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndotoxinBiological
Low dose endotoxin (0.8 ng/kg of body weight) as IV bolus
Partial sleep deprivationBehavioural
Partial night sleep deprivation by staying awake from 23:00 to 03:00
PlaceboOther
0.9% saline as IV bolus
Uninterrupted sleepOther
Uninterrupted sleep from 23:00 to 07:00
| Study group | Role | What they receive |
|---|---|---|
| Uninterrupted sleep & placebo | Placebo comparator | Uninterrupted sleep followed by placebo Receives: Other: Placebo; Other: Uninterrupted sleep |
| Uninterrupted sleep & endotoxin | Experimental | Uninterrupted sleep followed by endotoxin 0.8 ng/kg of body weight IV bolus Receives: Biological: Endotoxin; Other: Uninterrupted sleep |
| Partial sleep deprivation & placebo | Experimental | Partial sleep deprivation followed by placebo Receives: Behavioral: Partial sleep deprivation; Other: Placebo |
| Partial sleep deprivation & endotoxin | Experimental | Partial sleep deprivation followed by endotoxin 0.8 ng/kg of body weight IV bolus Receives: Biological: Endotoxin; Behavioral: Partial sleep deprivation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in depressive symptoms from baseline
Short Form of the Profile of Mood States (POMS-SF)
Measured: At baseline and then at 1, 1.5, 2, 3, 4, 5, and 6 hours after drug administration
Secondary outcomes (3)
Change in fatigue from baseline
Short Form of the Profile of Mood States (POMS-SF)
Measured: At baseline and then at 1, 1.5, 2, 3, 4, 5, and 6 hours after drug administration
Change in pain from baseline
Modified Pennebaker Inventory of Limbic Languidness (PILL) and Visual Analogue Scale (VAS)
Measured: At baseline and then at 1, 1.5, 2, 3, 4, 5, and 6 hours after drug administration
Anhedonia
Facial expressions and skin conductance in response to funny film clips
Measured: 2 hours after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionJan 2021
- Study completionJan 2021
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.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyong Jin Cho, University of California, Los Angeles
- Investigators
- Hyong Jin Cho, MD, PhD, Principal investigator, University of California, Los AngelesMichael R Irwin, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02270619
- Sponsor's protocol ID
- K23AG049085
- Acronym
- SHINE
- Status last verified
- Feb 2021
- First submitted
- 15 Oct 2014
- Last updated
- 18 Feb 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Loss as a Vulnerability Factor for Inflammation Induced Depressive Symptoms in Older Women
- ClinicalTrials.gov ID
- NCT02270619
- Acronym / sponsor ID
- SHINE / K23AG049085
- Conditions
- Depression
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Jan 2021 (actual)
- Study completion
- Jan 2021 (actual)
- First posted
- 21 Oct 2014 (estimated)
- 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.
Late-life depression is a major public health burden due to its high prevalence and associated morbidity, suicide risk, functional decline, and mortality. Unfortunately, current antidepressant therapies have limited effectiveness; hence, biologically plausible models for new treatments are being pursued. Systemic inflammation is hypothesized to play an important role on the onset and perpetuation of depression, especially in older women. Aging processes involve a heightened inflammatory state, and both inflammatory disorders and depression are more prevalent in women than men. However, increased systemic inflammation does not necessarily lead to depression in all women. Even when robust systemic inflammation is experimentally induced (e.g. endotoxin administration), largely variable increases in depressive symptoms are found. Defining the factors that account for this variability may identify individuals at risk of developing depression when exposed to heightened inflammatory states such as aging, obesity, and chronic disease, and informs future translational studies of depression prevention. In particular, the role of sleep disturbance in explaining this variability requires further attention because it is an independent risk factor for depression and heightens systemic inflammation by increasing the production of proinflammatory cytokines. The investigators have also discovered that women, but not men, who report sleep disturbance including short sleep duration experience significantly more depressive symptoms in response to an inflammatory challenge than women without sleep disturbance. Thus, it is hypothesized that sleep loss is a vulnerability factor for inflammation-induced depressive symptoms in women. However, to date, no experimental approach has been used to evaluate the role of sleep loss on inflammation-induced depressive symptoms. This proposal aims to examine this hypothesis by partial sleep deprivation (PSD) followed by endotoxin challenge in older women. It also aims to explore genomic and socio- emotional mechanisms underlying the association between sleep loss and depressive symptoms. In a randomized controlled factorial design, 80 healthy female volunteers aged 60 to 80 will be randomly assigned to one of 4 arms: 1) uninterrupted sleep followed by placebo; 2) uninterrupted sleep followed by endotoxin; 3) PSD followed by placebo; or 4) PSD followed by endotoxin. Subjects will be administered placebo or endotoxin in the morning after PSD or uninterrupted sleep. Depressive symptoms will be repeatedly assessed over 6 hours after placebo or endotoxin administration.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Uninterrupted sleep & placebo | Placebo comparator | Other: Placebo, Other: Uninterrupted sleepUninterrupted sleep followed by placebo |
| Uninterrupted sleep & endotoxin | Experimental | Biological: Endotoxin, Other: Uninterrupted sleepUninterrupted sleep followed by endotoxin 0.8 ng/kg of body weight IV bolus |
| Partial sleep deprivation & placebo | Experimental | Behavioral: Partial sleep deprivation, Other: PlaceboPartial sleep deprivation followed by placebo |
| Partial sleep deprivation & endotoxin | Experimental | Biological: Endotoxin, Behavioral: Partial sleep deprivationPartial sleep deprivation followed by endotoxin 0.8 ng/kg of body weight IV bolus |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- to be in good general health
- to be female
- to be aged 60 to 80 years
Key exclusion criteria (15 listed)
- presence of chronic mental or physical illnesses
- history of allergies, auto-immune, liver, or other chronic diseases
- current use of prescription medications such as steroids, non-steroid anti-inflammatory drugs, immune modifying drugs, opioid analgesics, and psychotropic medications
- current sleep disorders such as insomnia or sleep apnea
- nightshift work or time zone shifts (> 3 hours) within the previous 6 weeks
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 |
|---|---|---|
| EndotoxinLow dose endotoxin (0.8 ng/kg of body weight) as IV bolus | Biological | Partial sleep deprivation & endotoxin, Uninterrupted sleep & endotoxin |
| Partial sleep deprivationPartial night sleep deprivation by staying awake from 23:00 to 03:00 | Behavioural | Partial sleep deprivation & endotoxin, Partial sleep deprivation & placebo |
| Placebo0.9% saline as IV bolus | Other | Partial sleep deprivation & placebo, Uninterrupted sleep & placebo |
| Uninterrupted sleepUninterrupted sleep from 23:00 to 07:00 | Other | Uninterrupted sleep & endotoxin, Uninterrupted sleep & placebo |
Primary outcome
Change in depressive symptoms from baseline
Time frame: At baseline and then at 1, 1.5, 2, 3, 4, 5, and 6 hours after drug administration
Short Form of the Profile of Mood States (POMS-SF)
3 secondary outcomes
Change in fatigue from baseline
Time frame: At baseline and then at 1, 1.5, 2, 3, 4, 5, and 6 hours after drug administration
Change in pain from baseline
Time frame: At baseline and then at 1, 1.5, 2, 3, 4, 5, and 6 hours after drug administration
Anhedonia
Time frame: 2 hours after drug administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
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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. This study is not recruiting at the moment.
Hyong Jin Cho, MD, PhD principal investigator
University of California, Los Angeles
Michael R Irwin, MD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Endotoxin, Partial sleep deprivation and Uninterrupted sleep in people with Depression, run by University of California, Los Angeles 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 3 inclusion and 15 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: finished, as of the sponsor's last update on 18 Feb 2021. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in depressive symptoms from baseline (time frame: At baseline and then at 1, 1.5, 2, 3, 4, 5, and 6 hours after drug administration). 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 18 Feb 2021.