CompletedPhase 1

Sleep and Healthy Aging Research on Depression for Younger Women

United States40 participantsStarted 2019-10-02

Plain-language 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.

Who can participate

Age range

25 Years – 44 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 sessio…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Non-social (Monetary) Reward Response (Reward Learning and Sensitivity)

Timeframe: Baseline and post-injection (2.25 hrs)

Non-social (Monetary) Reward Response (Reward Motivation)

Timeframe: Baseline and post-injection (2.1 hrs)

Non-social (Monetary) Reward Response (Reward Sensitivity)

Timeframe: Baseline and post-injection (2.1 hrs)

General Social Reward Response (Reward Sensitivity Via Emotional Dot Probe)

Timeframe: Baseline and post-injection (2.7 hrs)

General Social Reward Response (Reward Sensitivity Via Face Morphing Task)

Timeframe: Baseline and post-injection (2.8 hrs)

General Social Reward Response (Social Reward Motivation)

Timeframe: Baseline and post-injection (2 hrs)

Trial details

NCT IDNCT03848715

SponsorUniversity of California, Los Angeles

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-07-22

Results submitted2024-03-05

View on ClinicalTrials.gov More Anhedonia trials

Plain-language summary

Who can participate

Age range

25 Years – 44 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Non-social (Monetary) Reward Response (Reward Learning and Sensitivity)

Timeframe: Baseline and post-injection (2.25 hrs)

Non-social (Monetary) Reward Response (Reward Motivation)

Timeframe: Baseline and post-injection (2.1 hrs)

Non-social (Monetary) Reward Response (Reward Sensitivity)

Timeframe: Baseline and post-injection (2.1 hrs)

General Social Reward Response (Reward Sensitivity Via Emotional Dot Probe)

Timeframe: Baseline and post-injection (2.7 hrs)

General Social Reward Response (Reward Sensitivity Via Face Morphing Task)

Timeframe: Baseline and post-injection (2.8 hrs)

General Social Reward Response (Social Reward Motivation)

Timeframe: Baseline and post-injection (2 hrs)