Sleep and Healthy Aging Research for Depression (SHARE-D) Study (SHARE-D)
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|ClinicalTrials.gov Identifier: NCT03256760|
Recruitment Status : Recruiting
First Posted : August 22, 2017
Last Update Posted : April 2, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Depression in Old Age||Biological: Endotoxin Biological: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Endotoxin vs. Placebo|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Masking Description:||Blinded infusion|
|Official Title:||Experimental Model of Depression in Aging: Insomnia, Inflammation, and Affect Mechanisms|
|Actual Study Start Date :||January 1, 2018|
|Estimated Primary Completion Date :||May 30, 2022|
|Estimated Study Completion Date :||May 30, 2023|
Endotoxin 0.8 ng/kg body weight
Placebo Comparator: Placebo
- Depressed Mood Subscale of the Profile of Mood States (POMS) [ Time Frame: 12 hours ]The Depressed Mood Subscale of the POMS is a self-reported assessment of depressed mood in which subjects rate severity of depressed mood 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
- Depressed mood and depressive symptoms as measured by the Montgomery Asberg Depression Rating Scale (MADRS) [ Time Frame: 12 hours ]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
- Emotion Facial Recognition Task [ Time Frame: about 2 hours ]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.
- Emotion Intensity Task [ Time Frame: about 2 hours ]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
- Reward Learning Task [ Time Frame: about 2 hours ]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.
- Effort Expenditure for Reward Task [ Time Frame: about 2 hours ]Similar to the Reward Learning Task, this is a computer based reward task to evaluate reward processing in the context of monetary reward.
- Social Reward Task [ Time Frame: about 2 hours ]This will evaluate another component of reward by subjective reports and task sensitivity to general social rewards
- Systemic marker of inflammation as indexed by interleukin-6 [ Time Frame: 12 hours ]Systemic inflammation as measured by circulating levels of interleukin-6 in plasma in pg/ml. Each timepoint is assayed and analyses examine the temporal profile of change with assessment every hour
- Genomic marker of inflammation [ Time Frame: about 2 hours ]Transcriptional profile of inflammation as measured by Conserved Translational Response to Adversity in circulating peripheral blood mononuclear cells
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03256760
|Contact: Michael Irwin, MDfirstname.lastname@example.org|
|Contact: Hyong Choemail@example.com|
|United States, California|
|Cousins Center for Psychoneuroimmunology, UCLA Neuropsychiatric Institute||Recruiting|
|Los Angeles, California, United States, 90095|
|Contact: Michael Irwin, MD 310-825-8281 firstname.lastname@example.org|
|Contact: Hyong Cho, MD, PhD 310-260-7492 email@example.com|
|Principal Investigator: Michael R. Irwin, MD|