Phase 1
N=40
Sleep and Healthy Aging Research on Depression for Younger Women
Anhedonia · Depression
Bottom Line
View on ClinicalTrials.gov: NCT03848715 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: Non-social (Monetary) Reward Response (Reward Learning and Sensitivity) — .563; .307; .309; .366 response bias — p=.16
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Endotoxin (Biological); Placebo (Biological)
- Age
- Adult · 25+ yrs
- Sex
- Female
- Sponsor
- University of California, Los Angeles
- Primary completion
- Jul 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Non-social (Monetary) Reward Response (Reward Learning and Sensitivity) |
.563; .307; .309; .366 | .16 |
| PRIMARY Non-social (Monetary) Reward Response (Reward Motivation) |
-.3597425; -.0876787 | — |
| PRIMARY Non-social (Monetary) Reward Response (Reward Sensitivity) |
-.0525937; .0521303 | — |
| PRIMARY General Social Reward Response (Reward Sensitivity Via Emotional Dot Probe) |
11.85463; 5.806407 | — |
| PRIMARY General Social Reward Response (Reward Sensitivity Via Face Morphing Task) |
.0092593; .0657895 | — |
| PRIMARY General Social Reward Response (Social Reward Motivation) |
-2.94; -.29 | — |
| SECONDARY Depressed Mood Subscale of the Profile of Mood States (POMS) |
6.939871; 2.680794 | — |
| SECONDARY Close Social Reward Response |
— | — |
| SECONDARY Consummatory Daily Reward Response |
— | — |
| SECONDARY Dopaminergic Activity |
— | — |
| SECONDARY Anticipatory Daily Reward Response |
— | — |
Summary
Compelling evidence indicates inflammation plays a role in depression, but potential mechanisms linking inflammation to depression, such as dysregulated reward processing, are poorly understood. This study comprehensively evaluates effects of inflammation on reward across dimensions (e.g., anticipating versus receiving a reward) and types (e.g., money vs. smiling faces) in younger and older women. Characterizing how inflammation shapes the dynamic and multidimensional reward system, and how this may differ by age, may give insight into risk factors for depression and help identify critical points for intervention.
Eligibility Criteria
Inclusion Criteria
- Participants will be required to be in good general health (as evaluated during the phone and in-person baseline session)
- Participants will be biologically female and premenopausal (as evaluated by self report).
- Participants will 25-44 years of age.
Exclusion Criteria
- Presence of chronic mental or physical illness
- 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).
- Nightshift work or time zone shifts (> 3hrs) within the previous 6 weeks
- 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
- Lifetime history of suicide attempt or inpatient psychiatric admission.
- 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
- 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.
- Body mass index > 35 because of the effects of obesity on proinflammatory cytokine activity
- Any clinically significant abnormality on screening laboratory tests
- Clinically significant abnormalities in electrocardiogram
Data sourced from ClinicalTrials.gov (NCT03848715). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.