REVEAL Study - Diagnostic Testing for PTSD Using the Senseye Diagnostic Tool
RecruitingThe goal of the REVEAL PTSD study is to test how well the Senseye DT works as a diagnostic test for Post-traumatic Stress Disorder (PTSD) in adults 18 and older who are experiencing one or more symptoms that might be related to PTSD. The Senseye DT is software as a medical device (SaMD) and is an iPhone app that administers a series of simple tasks on the phone while recording video during the tasks through the front-facing camera. The videos are analyzed by a an Artificial Intelligence (AI) algorithm to identify physiologic signals that might be indicative of PTSD. Data collected in this study will be used to train and tune the AI algorithm, then test it for accuracy. The main questions this study aims to answer are: 1. How accurate is the Senseye DT in detecting PTSD compared to structured clinical interviews, the current clinical standard for diagnostic testing? 2. How accurately does the Senseye DT predict PTSD severity? 3. How fast is the Senseye DT to use compared to structured clinical interviews? Participants will attend a virtual screening visit via video call to determine eligibility and consent to participate. Once enrolled, participants will attend 2 or 3 additional study visits: * Visit 1: A virtual visit where standard mental health assessments will be given by clinical raters trained in mental health and administering these structured clinical interviews. These assessments include the Structured Interview Guide for the Montgomery-Asburg Depression Rating Scale (SIGMA), the Structured Interview Guide for the Hamilton Anxiety Scale (SIGH-A), and the MINI International Neurodiagnostic Interview. The Clinician-Administered PTSD Scale for DSM-5 Revised Version (CAPS-5-R) may also be conducted, if randomly selected. * Visit 2: A visit to use the Senseye DT. For participants near one of the study's physical site locations, this visit will be done in person at the site. For all others, this visit will be conducted virtually. * Visit 3: For participants not randomly selected to have the CAPS-5-R administered at Visit 1, a third and final visit will be scheduled for this assessment. This visit will be conducted virtually. The total expected participation time for enrolled participants is 6-7 hours over the course of 2-3 weeks.
PhasePhase 3
TypeInterventional
Age18 Years
WhereAurora, Colorado, United States + 5 more
SponsorSenseye, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Evaluate the Effectiveness of DT-101 as an Adjunctive Treatment in Patients With Depression
RecruitingIn this study, researchers will learn more about a study drug called DT-101 in participants with Major Depressive Disorder (MDD), a form of depression. The goal of this clinical trial is to learn if DT-101 can treat depression in adults. The effect of DT-101 will be compared to placebo. A placebo looks the drug but contains no medicine. Subjects will attend the clinic for complete general health checks and to complete questionnaires.
PhasePhase 2
TypeInterventional
Age18 Years – 75 Years
WherePhoenix, Arizona, United States + 22 more
SponsorDraig Therapeutics Ltd
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of Brenipatide in Adult Participants With Major Depressive Disorder
NCT07412756 · Depressive Disorder, Major
RecruitingThis 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.
PhasePhase 3
TypeInterventional
Age18 Years – 75 Years
WhereMoorpark, California, United States + 178 more
SponsorEli Lilly and Company
▾Tap for detailsClick for full details — eligibility, all locations, contacts Home-Based tDCS Treatment Of Major Depressive Disorder
RecruitingThe REACH-tDCS study will evaluate the safety and efficacy of a noninvasive, at-home self-administered Sooma tDCS brain stimulation treatment for Major Depressive Disorder. The study uses randomized, blinded, placebo controlled design. The participants are assessed with video interviews and self-reports during the study, which lasts for 10 weeks followed by an optional continuation period.
PhaseNA
TypeInterventional
Age22 Years – 70 Years
WhereBoston, Massachusetts, United States
SponsorSooma Medical Inc
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Evaluate the Efficacy of AXS-05 Compared to Bupropion in Preventing the Relapse of Depressive Symptoms
RecruitingThis is a randomized, double-blind, active-controlled, multi-center study to evaluate the efficacy of AXS-05, compared to bupropion, in preventing the relapse of depressive symptoms in subjects with major depressive disorder (MDD) who have responded to treatment with AXS-05.
PhasePhase 4
TypeInterventional
Age18 Years – 65 Years
WhereBellflower, California, United States + 39 more
SponsorAxsome Therapeutics, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts Treatment ResistAnt Depression Subcallosal CingulatE Network DBS (TRANSCEND)
RecruitingThe goal of this clinical trial is to evaluate the effectiveness and safety of bilateral stimulation of the subcallosal cingulate white matter (SCCwm) using Deep Brain Stimulation (DBS) as an adjunctive treatment of non-psychotic unipolar Major Depressive Disorder (MDD) in adults.
PhaseNA
TypeInterventional
Age22 Years – 70 Years
WhereBirmingham, Alabama, United States + 24 more
SponsorAbbott Medical Devices
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Randomized Study of Azetukalner Versus Placebo in Major Depressive Disorder (X-NOVA3)
RecruitingX-NOVA3 is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy, safety, and tolerability of azetukalner as a monotherapy in adult participants diagnosed with Major Depressive Disorder (MDD)
PhasePhase 3
TypeInterventional
Age18 Years – 74 Years
WhereDothan, Alabama, United States + 49 more
SponsorXenon Pharmaceuticals Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts Triage Survey for Psychiatry Research Eligibility
RecruitingTRIAGE-Psych is a survey study designed to assess potential participants' eligibility to screen for industry-sponsored psychiatry clinical trials.
Phase—
TypeObservational
Age18 Years
WhereBoston, Massachusetts, United States + 5 more
SponsorAdams Clinical
▾Tap for detailsClick for full details — eligibility, all locations, contacts NBI-1065845-MDD3025: Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
RecruitingThe study will evaluate the efficacy of NBI-1065845 compared with placebo as an adjunctive treatment in participants with MDD on improving symptoms of depression.
PhasePhase 3
TypeInterventional
Age18 Years
WhereHuntsville, Alabama, United States + 38 more
SponsorNeurocrine Biosciences
▾Tap for detailsClick for full details — eligibility, all locations, contacts The goal of this study is to examine how whole-body hyperthermia affects the thermoinflammatory profile, which includes the combined immune and heat shock response, in patients with depression and whether these changes correlate with decreased depression in individuals with Major Depressive Disorder.
PhaseNA
TypeInterventional
Age18 Years – 65 Years
WhereBoston, Massachusetts, United States
SponsorMassachusetts General Hospital
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Evaluate the Efficacy and Safety of Esketamine for Reduction of Symptoms of Major Depressive Disorder
NCT07227454 · Depressive Disorder, Major
RecruitingThe purpose of this study is to evaluate how well JNJ-54135419 works (efficacy) in addition to comprehensive standard of care (SoC) in rapidly reducing the symptoms of major depressive disorder (MDD, a mental disorder characterized by a persistent feeling of sadness and loss of interest in activities) as compared with psychoactive placebo (does not contain JNJ-54135419) plus SoC in adolescent participants with acute suicidal ideation or behavior.
PhasePhase 3
TypeInterventional
Age12 Years – 17 Years
WhereBirmingham, Alabama, United States + 38 more
SponsorJanssen Research & Development, LLC
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Phase 3 Trial of DT120 for Major Depressive Disorder (Ascend)
RecruitingA 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
PhasePhase 3
TypeInterventional
Age18 Years – 74 Years
WhereLittle Rock, Arkansas, United States + 29 more
SponsorDefinium Therapeutics US, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts Accelerated TMS for Perinatal Depression
RecruitingWe are studying a treatment for depression called accelerated Transcranial Magnetic Stimulation (TMS) among pregnant and postpartum individuals. TMS is a focal, non-invasive form of brain stimulation that is cleared by the Food and Drug Administration for depression. Typically, traditional TMS involves daily treatments for 6-8 weeks. In this study, we will offer an accelerated form of TMS that involves multiple daily treatments for 5 days.
PhaseNA
TypeInterventional
Age18 Years – 55 Years
WhereBoston, Massachusetts, United States
SponsorBrigham and Women's Hospital
▾Tap for detailsClick for full details — eligibility, all locations, contacts Mechanisms Of Orbitofrontal Stimulation in Depression
RecruitingThe orbitofrontal cortex (OFC), a region involved in emotional regulation, decision making, and reward processing, is a key area linked to antidepressant response. This study tests whether noninvasive stimulation of the OFC using transcranial magnetic stimulation (TMS) can improve depressive symptoms. TMS uses magnetic fields generated by a coil placed next to the scalp to alter brain activity.
PhaseNA
TypeInterventional
Age18 Years – 65 Years
WhereBoston, Massachusetts, United States
SponsorSubha Subramanian
▾Tap for detailsClick for full details — eligibility, all locations, contacts Neuroactive Steroid to Treat Depressed Mood: A Trial for People With HIV
RecruitingThis study will determine the effects of pregnenolone on brain function, inflammation and depressive symptoms in people with HIV who have depression. Participants in this study will receive a pill of either pregnenolone or placebo, and can stay on their current antidepression medications. Brain imaging and behavioral assessments will be performed during the study.
PhasePhase 2
TypeInterventional
Age18 Years – 85 Years
WhereBoston, Massachusetts, United States
SponsorMassachusetts General Hospital
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of Seltorexant as Monotherapy in Adults and Elderly Participants With Major Depressive Disorder
NCT07573176 · Depressive Disorder, Major
RecruitingThe 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.
PhasePhase 3
TypeInterventional
Age18 Years – 74 Years
WhereBryant, Arkansas, United States + 38 more
SponsorJanssen Research & Development, LLC
▾Tap for detailsClick for full details — eligibility, all locations, contacts Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
RecruitingThe study will evaluate the efficacy of NBI-1065845 compared with placebo as an adjunctive treatment in participants with MDD on improving symptoms of depression.
PhasePhase 3
TypeInterventional
Age18 Years
WhereLittle Rock, Arkansas, United States + 17 more
SponsorNeurocrine Biosciences
▾Tap for detailsClick for full details — eligibility, all locations, contacts The purpose of this study is to examine the feasibility, acceptability, and preliminary efficacy of a digital intervention for co-occurring cannabis use and depression. Participants will be randomized to complete Amplification of Positivity - Cannabis Use (AMP-C) or symptom tracking. The main outcomes will include changes in depressive symptoms and cannabis use, as well as usability ratings.
PhaseNA
TypeInterventional
Age18 Years
WhereBoston, Massachusetts, United States
SponsorMassachusetts General Hospital
▾Tap for detailsClick for full details — eligibility, all locations, contacts Brain Stimulation for Severe Depression
RecruitingChronic intracalvarial cortical stimulation is a minimally invasive method involving the neurosurgical placement of an electrode above the inner table of the skull. Over time, intracalvarial cortical stimulation is intermittently activated to modulate locally and distally connected brain regions. Because of the important role played by the dorsolateral prefrontal cortex in mood regulation, the goal of this study is to apply intracalvarial prefrontal cortical stimulation (IpCS) over the dorsolateral prefrontal cortex in severely treatment-resistant depressed (TRD) patients. Per the DSM-V and Centre for Medicare and Medicaid Services (CMS) nomenclatures, TRD patients are commonly defined as those whose treatment failed to produce response or remission after 2 or more attempts of sufficient duration and treatment dose. In the investigator's study, eligible TRD subjects will have a diagnosis of major depressive disorder with a suboptimal response to an adequate dose and duration of at least two different antidepressant treatment categories. These subjects will also have had exposure and transiently (non-durably) responded to non-invasive neurostimulation. The investigator anticipates that severely Treatment Resistant Depressed (TRD) Subjects with IpCS of the dorsolateral prefrontal cortex will show a significant decrease in depression symptoms as measured by the Montgomery-Asberg Depression Rating Scale (MADRS) at four months post-implant when compared to baseline. The investigator will enroll up to 20 subjects with severe refractory depression in an open trial, followed for up to one year. Depressive and cognitive symptoms will be rated periodically to assess the safety and efficacy of this procedure.
PhaseNA
TypeInterventional
Age21 Years – 80 Years
WhereBoston, Massachusetts, United States + 1 more
SponsorInner Cosmos Inc
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Randomized Study of Azetukalner Versus Placebo in Major Depressive Disorder
RecruitingX-NOVA2 is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy, safety, and tolerability of azetukalner as a monotherapy in adult participants diagnosed with Major Depressive Disorder (MDD)
PhasePhase 3
TypeInterventional
Age18 Years – 74 Years
WherePhoenix, Arizona, United States + 50 more
SponsorXenon Pharmaceuticals Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts