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Clinical Trials: Psychiatry - General Adult/Mental Health (Depression, Anxiety, Etc.)
IRB No. 16-055-2 (Dr. David Steffens, PI): Department of Psychiatry: Adult Repository
The purpose of the repository is to prospectively collect biological samples along with clinical data to facilitate future research studies and pilot analysis related to medical and behavioral health research.
IRB No. 21-046-2 (Dr. Kevin Manning, PI): Cognitive Remediation of Cognitive Control in Late-Life Depression
This research is being completed because depressed older adults commonly experience difficulties with concentration and processing speed, also called executive dysfunction, as well as negative affect/emotions (e.g., low mood, irritability, worry). Older adults with depression and executive dysfunction and/or negative affect/emotions regularly fail to get better with conventional antidepressant medications. Therefore, the purpose of this study is to use an established non-invasive treatment (computerized brain-training) that may improve cognitive and depression related outcomes in older adults. There are two aims of the current study. We are interested in whether a computerized braintraining treatment will improve thinking and depression in older depressed adults. We are also interested in whether participating in the treatment will result in changes to brain activity measured with magnetic resonance imaging (MRI).
IRB No. 21-257-2 (Dr. Breno Diniz, PI): The SenDep Study: Linking Molecular Senescence Changes to Depression and Cognitive Impairment in Late Life
Late-life depression (LLD) is a common mental disorder in the elderly, with prevalence rates ranging from 1 to 5%. Recent evidence suggests that LLD is linked to age-related negative health outcomes, such as cerebrovascular disease, increased risk of Alzheimer's disease, vascular dementia, and of premature mortality. The mechanisms of LLD are complex and involve the dysregulation of different biological pathways. Understanding the interplay between the biological changes in aging and depression can provide insight into the mechanisms by which LLD increases the risk of negative health outcomes. This study proposes to evaluate the association of Senescence-Associated Secretory Phenotype (SASP) Index with different clinical phenotypes of aging (i.e., cognitive impairment) and with cellular senescence phenotype (i.e., leukocyte telomere [LT] attrition) in LLD. Finally, we will evaluate the trajectory of changes in SASP, and its relationship with cognitive performance in these individuals. Our hypotheses are that LLD individuals will show a significantly higher SASP index compared to age- and gender-matched never-depressed control subjects. SASP index will be significantly associated with greater cognitive impairment and telomere attrition in LLD subjects. We further hypothesize that an increasing or persistently higher SASP index trajectory will lead to faster cognitive decline among study participants over two years of follow-up. To our knowledge, this will be the first study to examine the association between circulating molecular senescence markers (SASP), a cellular senescence marker (LT attrition), and neurocognitive and clinical characteristics in LLD. Based on the results of this study, we will also be able to identify novel targets for the development of interventions aiming not only the treatment of depression in the elderly but also aiming the prevention of the negative outcomes related to this condition
IRB No. 22-287-2 (Dr. Kevin Manning, PI): Apathy: An Early Manifestation of Frailty and Disability in Older Adults with Depression?
The overall objective of this research is to understand whether a subtype of depression in older adults - apathy - heralds the onset of disability. This pilot project will test the hypotheses that there will be differences in functional performance and blood-based biomarkers between older depressed adults with and without apathy.
IRB No. 22-330S-1 (Dr. Angela Bermudez Millan, PI): Implicit Affectivity and Transition to a Plant-based Diet
This pre- and post-test study design aims to identify the impact of dietary change on mood. We will follow for three-months a sample of 30 adults that transition to a plant-based diet. The main outcome is the Implicit Positive and Negative Affect Test. Participants will complete this assessment at baseline and at 3-months. We may be able to associate dietary intake changes with changes in affect. This could help describe the underlying mechanisms that lead to depression. In doing so this study may serve to emphasize the importance of diet in managing depression risk. Specific Aim 1: To examine the change in plant and animal-based intake after transition to a plant-based diet. Specific Aim 2: To examine the change in implicit affectivity in adults after transition to a plant-based diet. Specific Aim 3: To examine the association between plant-based intake and implicit affectivity.
IRB No. W23-093-2 (Dr. Neha Jain, PI): An Open-label, Long-term, Safety and Efficacy Study of Aticaprant as Adjunctive Therapy in Adult and Elderly Participants With Major Depressive Disorder (MDD)
This is a clinical study of an investigational medication for adults with Major Depressive Disorder (MDD). The purpose of the study is to evaluate the effectiveness of Aticaprant when used as an add-on treatment for adults with MDD. Study participation lasts 8 weeks and includes a screening phase, a double blinded phase and a follow-up phase. There is also an optional open-label phase study for those who qualify.
IRB No. W23-227-1 (Dr. Neha Jain, PI): A Study of Disease Characteristics and Real-life Standard of Care Effectiveness in Patients with Major Depressive Disorder (MDD) With Anhedonia and Inadequate Response to Current Antidepressant Therapy Including an SSRI or SNRI.
This is an observational study for adults with Major Depressive Disorder (MDD). The purpose of this study is to collect information on participants’ well-being and how depression treatments help over the course of their study participation. No study medication is used in this observational study. Participants will continue to take their current medications as prescribed by their provider(s).
IRB No. W24-025-2 (Dr. Andrew Winokur, PI): A Randomized, Double-Blind, Placebo-Controlled Trial of REL-1017 as an Adjunctive Treatment for Major Depressive Disorder (RELIGHT)
This is a clinical study of an investigational medication for adults with Major Depressive Disorder (MDD). The purpose of the study is to evaluate the effectiveness of REL-1017 when used as an add-on treatment for adults with MDD. Study participation lasts 8 weeks and includes a screening phase, a double blinded phase and a follow-up phase.
IRB No. U23-210-2 (Dr. Jayesh Kamath, PI): A Randomized, Double-Blind, Placebo-controlled Multicenter Study to Assess the Efficacy and Safety of Lumateperone as Adjunctive Therapy in the Treatment of Patients with Major Depressive Disorder.
This is a clinical study of an investigational medication for adults with Major Depressive Disorder (MDD). The purpose of the study is to evaluate the effectiveness of Lumateprone when used as an add-on treatment for adults with MDD. Study participation lasts 8 weeks and includes a screening phase, a double blinded phase and a follow-up phase.