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Depression in Old AgePhase 1SHARE-DNCT03256760

Sleep and Healthy Aging Research for Depression (SHARE-D) Study

A Phase 1 study testing Endotoxin in people with Depression in Old Age, run by Michael Irwin, MD at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Late-life depression is a significant public health concern, and effective interventions for prevention and treatment are needed. Insomnia and inflammation are modifiable targets for depression prevention, and this study is significant in using an experimental approach (i.e., inflammatory challenge) to probe acute… Read more about this study

Who is it for?
Ages 60 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Depression in Old Age
What is being tested?
Endotoxin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
160 participants
Where
1 siteUnited States
Study dates
23 Aug 2017to 30 Apr 2024
Phase
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
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Participants will be required to be in good general health (as evaluated during the phone and in-person baseline session)
  • Participants will be aged 60 to 80 years.
  • Half the participants (N=80) will be those with insomnia disorder as diagnosed by the Structured Clinical Interview for Diagnosis, Diagnostic Statistical Manual 5 and the Duke Structured Interview for Sleep Disorders, .
  • The other half will be those without insomnia identified as not having insomnia by any of these assessments.
  • Exclusion Criteria: Following a structured telephone interview, prospective participants with the following conditions will not advance to the in-person baseline session:
  • Presence of chronic mental or physical illness (except for insomnia)
Show all 27Show fewer
  • History of allergies, autoimmune, liver, or other severe chronic diseases,
  • Current and regular use of prescription medications such as steroids, non-steroid anti-inflammatory drugs, aspirin, immune modifying drugs, opioid analgesics, statins, antihypertensive drugs, anti-arrhythmic drugs, and antidepressant medications (none in the last 6 months); and nightshift work or time zone shifts (> 3hrs) within the previous 6 weeks, or previous history of fainting during blood draws.
  • Presence of co-morbid medical conditions not limited to but including cardiovascular (e.g., history of acute coronary event, stroke) and neurological diseases (e.g., Parkinson's disease), as well as pain disorders;
  • Presence of comorbid inflammatory disorders such as rheumatoid arthritis or other autoimmune disorders;
  • Presence of an uncontrolled medical condition that is deemed by the investigators to interfere with the proposed study procedures, or to put the study participant at undue risk;
  • Presence of chronic infection, which may elevate proinflammatory cytokines;
  • Presence of an acute infectious illness in the two weeks prior to an experimental session.
  • Current Axis I psychiatric disorders as determined by the Research Version of the Structured Clinical Interview including a current major depressive disorder and substance dependence (a prior history of depression is not an exclusion criterion, which will be considered for a pre-planned sensitivity analysis and will be used as a pre-classification variable in the generation of the two groups, and in the randomization schedule);
  • Lifetime history of suicide attempt or inpatient psychiatric admission. Sleep Disorders:
  • Current history of sleep apnea or nocturnal myoclonus;
  • Phase-shift disorder, which will be identified by the Structured Clinical Interview and the Duke Structured Interview for Sleep Disorders ; Medication and Substance Use:
  • Current and/or past regular use of hormone-containing medications including steroids;
  • Current and/or past regular use of non-steroid anti-inflammatory drugs;
  • Current and/or past regular use of immune modifying drugs that target specific immune responses such as cytokine antagonists;
  • Current and/or past regular use of analgesics such as opioids;
  • Current and/or past regular use of cardiovascular medications, including antihypertensive, antiarrhythmic, antianginal, and anticoagulant drugs;
  • Use of antidepressant medications or other psychotropic medications; (16) current smoking or excessive caffeine use (>600 mg/day) because of the known effects on proinflammatory cytokine levels;
  • Evidence of recreational drug use from urine test. Health Factors:
  • Body mass index > 35 because of the effects of obesity on proinflammatory cytokine activity and also on risk for sleep disordered breathing;
  • Any clinically significant abnormality on screening laboratory tests
  • Clinically significant abnormalities in electrocardiogram

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Cousins Center for Psychoneuroimmunology, UCLA Neuropsychiatric Institute

    Los Angeles, California, 90095

Other trials in United States

About this study

Official title: Experimental Model of Depression in Aging: Insomnia, Inflammation, and Affect Mechanisms

Late-life depression is a significant public health concern, and effective interventions for prevention and treatment are needed. Insomnia and inflammation are modifiable targets for depression prevention, and this study is significant in using an experimental approach (i.e., inflammatory challenge) to probe acute inflammatory- and depression responses as a function of insomnia, which will inform identification of molecular targets for pharmacologic interventions, and improvement of insomnia treatments to prevent depression in older adults.

Project

Read the detailed description

This study (SHARE-D) will use an inflammatory challenge (i.e., endotoxin) to probe acute inflammatory- and depression responses (primary outcome) in older adults as a function of insomnia. Older adults with insomnia show chronic inflammation; sleep disturbance also activates inflammatory signaling; chronic inflammation primes acute inflammatory responses; chronic inflammation, as well as acute inflammatory reactivity, predict depression over the following year; and finally, endotoxin induces acute inflammation along with depressive symptoms, with preliminary evidence that "two-hits" (i.e., sleep disturbance and inflammatory challenge) are associated with exaggerated increases in depression, especially in women. In this placebo-controlled, randomized, double-blind study of low dose endotoxin in older adults (60-80 y; stratified by sex) with insomnia (n=60) vs. comparisons without insomnia (n=100), the investigators hypothesize that older adults with insomnia will show heightened inflammatory- and affective responding to inflammatory challenge as compared to those without insomnia. The investigation aims to: 1) examine differences in depressive symptoms and measures of negative affect responding as a function of insomnia and inflammatory challenge; 2) examine differences in measures of positive affect responding as a function of insomnia and inflammatory challenge; and 3) examine differences in experimentally-induced inflammation in relation to depressive symptoms and measures of negative- and positive affect responding as a function of insomnia.

Being tested
Endotoxin, Placebo
Keywords
Insomnia, depression
Medical subject headings
Sleep Initiation and Maintenance Disorders, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EndotoxinBiological

    Endotoxin

  • PlaceboBiological

    Placebo

Study groups in NCT03256760
Study groupRoleWhat they receive
EndotoxinExperimentalEndotoxin 0.8 ng/kg body weight
Receives: Biological: Endotoxin
PlaceboPlacebo comparatorPlacebo
Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Depressed Mood Subscale of the Profile of Mood States (POMS)

    The Depressed Mood Subscale of the POMS is a self-and observer rated assessment of depressed mood in which severity of depressed mood is rated using a visual analog scale from 1 to 5 (5 being most severe). Each timepoint is scored and analyses examine the temporal profile of change with assessment every hour

    Measured: 12 hours

  2. Depressed mood and depressive symptoms as measured by the Montgomery Asberg Depression Rating Scale (MADRS)

    Depressed mood and depressive symptom severity by self-reported assessment using the Montgomery Asberg Depression Rating scale with a range from 0 to 54 with a higher score indicating more severe depressive symptoms. Each timepoint is scored and analyses examine the temporal profile of change with assessment every 2 hours

    Measured: 8 hours

Secondary outcomes (8)

  1. Hamilton Depression Rating Scale

    The Hamilton Depression Rating Scale is on the most widely used scales in depression, which is adapted to evaluate acute changes in depressive symptoms. A trained interviewer, blind to the experimental condition, make ratings of items of depressed mood, feelings of guilt, loss of interest, retardation/agitation, anxiety, and somatic symptoms using items from the Hamilton Depression Rating Scale. The 17-item version will be used.

    Measured: 8 hours

  2. Emotion Facial Recognition Task

    This is a computer-based test that includes color photographs of facial expression of evoked-or felt-emotions: happy, sad, angry, fearful, disgusted, and nonemotional or neutral. Participants rate the emotional valence using a scale of 0-8 of each expression.

    Measured: about 2 hours

  3. Emotion Intensity Task

    This is a computer-based test used along with emotion facial recognition to test subjective ratings of perceived intensity in response to facially-expressed emotions

    Measured: about 2 hours

  4. Probabilistic Reward Task

    This is a probabilistic reward task that is administered using computerized reward-learning task rooted in signal detection theory that yields an objective measurement of participant's ability to modulate behavior as a function of rewards. The variable that will be scored is termed response bias (RB), which reflects participants' preference for the stimulus paired with more frequent rewards.

    Measured: about 2 hours

  5. Effort Expenditure for Reward Task

    Similar to the Reward Learning Task, this is a computer based reward task to evaluate reward processing in the context of monetary reward.

    Measured: about 2 hours

  6. Social Reward Task

    This will evaluate another component of reward by subjective reports and task sensitivity to general social rewards

    Measured: about 2 hours

  7. Snaith-Hamilton Pleasure Scale

    The Snaith-Hamilton Pleasure Scale (SHAPS) is a self-administered questionnaire with 14 items assessing four domains of pleasure response/hedonic experience: interest/pastimes, social interaction, sensory experience, and food/drink, with each item scored from 1 to 4.

    Measured: 8 hours

  8. Temporal Experience of Pleasure Scale

    This self-report scale rates interest in 10 different activities, how much a person is interested in doing that activity right now

    Measured: 8 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2017
  2. Study start23 Aug 2017
  3. Primary completion30 Apr 2024
  4. Study completion30 Apr 2024

Resources

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 1
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Endotoxin vs. Placebo
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03256760
Sponsor's protocol ID
16-000583
Acronym
SHARE-D
Status last verified
Aug 2024
First submitted
11 Aug 2017
Last updated
5 Sep 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Boyle CC, Cho JH, Eisenberger NI, Olmstead R, Sadeghi N, Castillo D, Irwin MR. Inflammation-induced depressed mood and reward responsivity as a function of age in female adults: a randomized controlled trial of endotoxin. Transl Psychiatry. 2025 Nov 26;16(1):6. doi: 10.1038/s41398-025-03752-2.

    PubMed 41298372

  • Irwin MR, Boyle CC, Cho JH, Piber D, Sadeghi N, Castillo D, Smith MT, Eisenberger NI, Olmstead R. Inflammatory Exposure and Depression in Older Adults With Insomnia: A Randomized Clinical Trial. JAMA Psychiatry. 2025 Sep 1;82(9):859-867. doi: 10.1001/jamapsychiatry.2025.1327.

    PubMed 40668551

  • DuPont CM, Olmstead R, Reid MJ, Hamilton KR, Campbell CM, Finan PH, Sadeghi N, Castillo D, Irwin MR, Smith MT. A randomized, placebo-controlled, double-blinded mechanistic clinical trial using endotoxin to evaluate the relationship between insomnia, inflammation, and affective disturbance on pain in older adults: A protocol for the sleep and Healthy Aging Research for pain (SHARE-P) study. Brain Behav Immun Health. 2023 May 19;30:100642. doi: 10.1016/j.bbih.2023.100642. eCollection 2023 Jul.

    PubMed 37256193

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Endotoxin in people with Depression in Old Age, run by Michael Irwin, MD 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 27 inclusion and 0 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 5 Sep 2024. 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?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Depressed Mood Subscale of the Profile of Mood States (POMS) (time frame: 12 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03256760, which also lists 3 linked publications.

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 Sep 2024.

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