The goal of this clinical trial is to improve how electroconvulsive therapy (ECT) stimulation settings are chosen. Researchers will use real-time brain monitoring to measure both seizures and a recently identified brain event called cortical spreading depolarization (CSD).
The main questions it aims to answer are:
What is the best way to increase ECT stimulation settings? How do different pulse settings affect the brain's response? Can certain settings produce CSD without causing a seizure?
Participants already receiving ECT as part of their care will take part. They will be assigned to one of two groups:
Index ECT group: Participants starting ECT will receive different standard titration approaches.
Maintenance ECT group: Participants receiving ongoing ECT will undergo a brief, low-dose stimulation test before treatment.
All participants will be monitored using brain physiology (EEG and blood flow) and symptom scales during treatment.
Depression - Major Depressive Disorder· University of Pennsylvania· Philadelphia, Pennsylvania
The goal of this clinical trial is to learn how transcranial magnetic stimulation (TMS) affects brain circuits involving the subgenual anterior cingulate cortex (sgACC) in adults with depression. The main questions it aims to answer are:
* Can brain responses in the sgACC before treatment predict improvement in depressive symptoms following TMS?
* Does a 6-week course of active TMS, compared with sham TMS, change brain responses in the sgACC?
* Are changes in sgACC responses during treatment associated with changes in depressive symptoms?
Researchers will compare active TMS with sham TMS to evaluate changes in the targeted brain circuit and depressive symptoms.
Participants will:
* Receive active or sham TMS every weekday for 6 weeks
* Undergo MRI scans with TMS before, during, and after the 6-week intervention to measure brain responses to stimulation
* Complete clinical assessments, questionnaires, and cognitive testing
* Complete follow-up assessments after the intervention
Depression· University of Pennsylvania· Philadelphia, Pennsylvania· Ages 18–65
The SUpporting Seniors Receiving Treatment And INtervention (SUSTAIN) program is a telephone-based clinical service designed to help identify and manage behavioral health issues among PACE/PACENET enrollees. The purpose of the current project is to a) explore moderators of treatment response among beneficiaries in the SUSTAIN Clinical Program and b) to evaluate the sustained clinical effects of the program.
Depression· University of Pennsylvania· Philadelphia, Pennsylvania
This study evaluates the safety and efficacy of brenipatide when administered with standard of care (SoC) compared to placebo plus SoC in delaying the return of major depressive symptoms.
The trial is divided into three periods as follows: a screening period that will last approximately 1 month, a treatment period that will last a minimum of 12 months, and the follow up period that will last approximately 2 months. The duration of study participation may vary and may be shortened if depression symptoms worsen or if withdrawal from the study occurs for any reason.
Depressive Disorder, Major· Eli Lilly and Company· Moorpark, California · Orange, California +3 more· Ages 18–75
The goal of this study is to test ways to help people improve their health and manage their medication for depression. This study will measure both medication adherence and depression outcomes.
Depression· University of Pennsylvania· Philadelphia, Pennsylvania· Ages 21–64
The study aims to verify if the Gaize ocular device can effectively identify eye movements indicative of prescribed psychotropic medication usage by employing Drug Recognition Expert (DRE) testing protocols within a controlled virtual environment.
The goal of this clinical trial is to learn if a four-week yoga program works to improve quality of life in people undergoing IVF (In Vitro Fertilization). It will also learn if a four-week yoga program decreases anxiety and depression symptoms in people undergoing IVF.
The main questions it aims to answer are:
* Does a four-week yoga program effect quality of life, anxiety, and depression symptoms in people undergoing IVF?
* Do the effects vary by individual characteristics of the people in the study?
Researchers will compare the yoga intervention group to routine care as usual.
Participants will:
* Participate in a weekly virtual yoga class for four weeks (total of four yoga classes), or follow routine care as usual while undergoing IVF.
* Take three online surveys every 4 weeks.
* Be involved in the study for 8 weeks.
Pain is common in children presenting to the emergency department but is frequently undertreated, leading to both short- and long-term consequences. Morphine is the standard treatment for children with moderate to severe acute pain, but its use is associated with serious side effects and caregiver and clinician concerns related to opioid administration. The investigators aim to determine if sub-dissociative ketamine is non-inferior to morphine for treating acute pain and a preferable alternative for treating acute pain in children because of its more favorable side effect profile and potential long-term benefits related to pain-related function, analgesic use/misuse, and mental and behavioral health outcomes.
Abdominal Pain· Columbia University· Los Angeles, California · Sacramento, California +3 more· Ages 6–17
The main purpose of this study is to assess how well the study drug (JNJ-42847922) works (efficacy) compared with placebo in improving depressive symptoms in participants with major depressive disorder (\[MDD\], a common mood disorder that causes a lasting feeling of sadness and a loss of interest in everyday activities) in double-blind treatment phase. Further, to evaluate long-term safety and tolerability of JNJ-42847922 in participants with MDD in the open label treatment phase.
This pilot randomized controlled trial will examine the feasibility, acceptability and preliminary efficacy of an adolescent depression prevention program, Brief Interpersonal Psychotherapy-Adolescent Skills Training (B-IPT-AST), in primary care.
Depressive Symptoms· Children's Hospital of Philadelphia· Philadelphia, Pennsylvania· Ages 13–17
NRG-CC015 is a prospective, randomized phase III clinical trial to evaluate the efficacy of two distinct digital approaches for delivering a mindfulness-based intervention: a live, instructor-led version delivered over Zoom (MAPs LO), and an app-based, self-paced version (MAPs App). Participants will include younger breast cancer survivors (BCS) who were diagnosed with breast cancer at or before age 50 years, have completed their primary cancer treatment (i.e., surgery, radiation, and/or chemotherapy) at least 6 months earlier, and report elevated depressive symptoms.
Breast Cancer· NRG Oncology· Phoenix, Arizona · Fort Smith, Arkansas +3 more· Ages 18–50
A Phase 3 Double-blind, Placebo-controlled Study (Part A) with an Open-label Extension (Part B) Evaluating DT120 Compared to Placebo in Major Depressive Disorder - Ascend
Major Depressive Disorder· Definium Therapeutics US, Inc.· Gilbert, Arizona · Little Rock, Arkansas +3 more· Ages 18–74
This study is being done to better understand how the study team can treat pain for people with cirrhosis and depression.
Enrolled participants on this feasibility study will be randomized to Transcutaneous Electrical Acustimulation (TEA) or sham TEA.
Cirrhosis· University of Michigan· Ann Arbor, Michigan · Philadelphia, Pennsylvania
In the treatment of Major Depressive Disorder (MDD), ketamine can produce rapid but short-lasting improvements in mood. In order to develop a new generation of treatments with rapid and sustained efficacy, a better understanding of the mechanism of action is urgently needed. One candidate mechanism is the modulation of synaptic strength mediated by glutamatergic activity as ketamine has been suggested to increase synaptic strength. Although determining how ketamine impacts the glutamatergic system is essential to isolating its mechanism of action, the invasive nature of most assessment methods has limited our ability to do so in humans. The proposed research aims to determine if changes in glutamatergic activity, reflecting the modulation of synaptic strength, underlie the antidepressant effects of ketamine. In this project, the investigators will utilize a novel measure of glutamate imaging, GluCEST, to assess changes in glutamatergic activity to assess synaptic strength following ketamine administration. Ten individuals (aged 25-65) with a DSM-V diagnosis of MDD will undergo baseline GluCEST imaging prior to and following ketamine infusion. Both clinician-administered and subjective mood measures will be collected. It is predicted that ketamine will improve mood and increase glutamatergic activity and synaptic strength. Results from this project have the potential to identify the modifiable mechanisms by which rapid antidepressants work which could ultimately stimulate the development of novel interventions that work through the modulation of glutamatergic activity.
Major Depressive Disorder (MDD)· University of Pennsylvania· Philadelphia, Pennsylvania· Ages 25–65
Phase II study for patients with Bipolar 1 Disorder experiencing major depressive episode. Patient eligible for enrollment will be randomized (like flipping a coin) to either active drug (LB-102 or placebo). Treatment is for 6 weeks.
Bipolar I Disorder· LB Pharmaceuticals Inc.· Bentonville, Arkansas · Little Rock, Arkansas +3 more· Ages 18–65
This is a prospective, randomized, controlled clinical trial in which clinicians from University of Pennsylvania Health Systems (UPHS) including Penn Medicine- Lancaster General Health (LGH) and Massachusetts General Hospital (MGH) are offered a well-known program to help reduce clinician burnout: Sudarshan Kriya Yoga (SKY) Breathing and Sahaj Meditation Intervention.
Burnout, Professional· Lancaster General Hospital· Boston, Massachusetts · Plainsboro, New Jersey +2 more· Ages 25–70
This is a randomized controlled trial of a dyad-centered, doula support and healthcare coordination model of care in a large urban neonatal intensive care unit (NICU), which serves a high-risk, low-income, majority Black population. In addition to doula support and coordination of care in the NICU, there will be a warm handoff to a community doula to continue the support once infants leave the Hospital of the University of Pennsylvania (HUP) NICU.
Stress Disorders, Post-Traumatic· University of Pennsylvania· Philadelphia, Pennsylvania
This pilot randomized controlled trial (RCT) will test the feasibility and acceptability of the informational intervention program, Heartsight, to reduce caregivers' uncertainty experienced throughout their child's illness trajectory after cardiac arrest. The investigator aims to enroll up to 30 caregivers of pediatric cardiac arrest patients to (Aim 1a) pilot recruitment and randomization (2:1) procedures, and (Aim 1b) estimate retention rate at 3 months and assess engagement and utilization metrics for frequency of access and time spent on each module of the informational packages. The investigator also aims to evaluate the association of the intervention with efficacy outcomes in an exploratory manner in preparation for a larger trial, including (Aim2a) a preliminary estimate of the association of intervention with the surrogate's uncertainty levels at 3 months post-discharge, and (Aim 2b) a preliminary estimate of the association of intervention with the surrogate's anxiety, depression, and post-traumatic stress symptoms at 3 months post-discharge.
Cardiac Arrest· Children's Hospital of Philadelphia· Philadelphia, Pennsylvania0
The goal of this research is to investigate whether a peer-delivered illness self-management program called Taking Action can help college students with serious mental illnesses. Participants will be randomly assigned to either the experimental condition (Taking Action) or the control condition (information only). Participants in the experimental condition will attend five 2.5-hour Taking Action sessions. Participants will complete three interviews (baseline, post-intervention, and follow-up) to assess how well the program works, is liked, and benefits students clinically and academically. The investigators seek to test the following hypotheses: Compared to controls, students who do the Taking Action program will report greater improvements in mental health self-management attitudes, skills, and behaviors and will report greater improvements in mental health symptoms and recovery, and better academic outcomes.
Major Depressive Disorder· Temple University· Philadelphia, Pennsylvania
The research study is being conducted to study brain patterns of negative emotion and develop personalized brain stimulation protocols to disrupt these patterns with transcranial magnetic stimulation (TMS). First, the investigators will use functional Magnetic Resonance Imaging (fMRI) data to generate a negative affect map for each participant. Then, the investigators will apply a variety of repetitive transcranial magnetic stimulation (rTMS) sequences while the participant is inside the MRI scanner to determine the optimal and least optimal rTMS frequencies at changing negative affect brain states. Finally, these two frequencies will be tested over two 3-day rTMS neuromodulation sessions to assess whether they can reduce negative emotions.
Rumination· University of Pennsylvania· Philadelphia, Pennsylvania· Ages 18–65