Zelquistinel or Placebo for the Reduction of Symptoms of Major Depressive Disorder
RecruitingThe goal of this clinical trial is to learn if zelquistinel works to treat depression in adults. It will also learn about the safety of zelquistinel. The main questions it aims to answer are: Does zelquistinel reduce depression scores in participants compared to participants who take a placebo (a look-alike tablet that contains no zelquistinel)? What medical problems are observed in participants who take zelquistinel? Participants will take one tablet of zelquistinel or placebo every week for 6 weeks. Participants will visit the clinic every week of the 6 week period to have the severity of their depression evaluated.
PhasePhase 2
TypeInterventional
Age18 Years – 64 Years
WhereBirmingham, Alabama, United States + 33 more
SponsorSyndeio Biosciences, Inc
▾Tap for detailsClick for full details — eligibility, all locations, contacts In the United States, adolescents experience alarmingly high rates of major depression, and gold-standard treatments are only effective for approximately half of patients. Rumination may be a promising treatment target, as it is well-characterized at the neural level and contributes to depression onset, maintenance, and recurrence as well as predicts treatment non-response. Accordingly, the proposed research will investigate whether an innovative mindfulness-based real-time functional magnetic resonance imaging (fMRI) neurofeedback intervention successfully elicits change in the brain circuit underlying rumination to improve clinical outcomes among depressed adolescents.
PhaseNA
TypeInterventional
Age13 Years – 18 Years
WhereBoston, Massachusetts, United States + 1 more
SponsorColumbia University
▾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 Cognitive Dysfunction and Inflammation in Depression: Experimental Inhibition Via Infliximab
NCT06136546 · Depressive Disorder, Major, Inflammation
RecruitingThis study is a mechanistic randomized controlled trial that investigates whether inhibition of tumor necrosis factor signaling via intravenous infusion of infliximab improves psychomotor speed and executive functioning in depressed individuals who exhibit an inflammatory phenotype.
PhasePhase 2
TypeInterventional
Age25 Years – 50 Years
WhereBoston, Massachusetts, United States
SponsorMassachusetts General Hospital
▾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 + 179 more
SponsorEli Lilly and Company
▾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 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 + 9 more
SponsorNeurocrine Biosciences
▾Tap for detailsClick for full details — eligibility, all locations, contacts Phase 3 Study of Adjunctive Treatment With Seltorexant in Adult and Elderly Participants With Major Depressive Disorder and Insomnia Symptoms
NCT06559306 · Depressive Disorder, Major
RecruitingThe purpose of this study is to know how well seltorexant works, and also to evaluate safety and maintenance effect of seltorexant compared with placebo as an adjunctive therapy to an antidepressant in improving depressive symptoms in participants with major depressive disorder with insomnia symptoms (MDDIS) who have had an inadequate response to current antidepressant therapy with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI).
PhasePhase 3
TypeInterventional
Age18 Years – 74 Years
WhereBirmingham, Alabama, United States + 204 more
SponsorJanssen Research & Development, LLC
▾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
WhereBellflower, California, United States + 15 more
SponsorJanssen Research & Development, LLC
▾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 "A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder"
RecruitingThe purpose of this study is to examine the efficacy, safety, and tolerability of CYB003 compared to matching placebo as adjunctive treatment in participants with MDD.
PhasePhase 3
TypeInterventional
Age18 Years – 85 Years
WherePhoenix, Arizona, United States + 46 more
SponsorCybin IRL Limited
▾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 + 23 more
SponsorAbbott Medical Devices
▾Tap for detailsClick for full details — eligibility, all locations, contacts Search for Novel Transcranial Magnetic Stimulation (TMS) Targets for Mental Illness
NCT06376734 ·
Major Depressive Disorder, Obsessive-Compulsive Disorder, Schizophrenia
RecruitingParticipants will receive Transcranial Magnetic Stimulation (TMS) at a random location in the left prefrontal cortex, excluding sites that are potentially unsafe. Extensive behavioral testing will be conducted to determine which behaviors are modulated by stimulating which circuits.
PhasePhase 2
TypeInterventional
Age18 Years – 65 Years
WhereSunnyvale, California, United States + 1 more
SponsorBrigham and Women's Hospital
▾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 Comparing the Efficacy of Heated Yoga and Sauna as a Treatment for Depression
RecruitingThis project explores whether heated yoga, sauna, and a mindfulness app reduce depressive symptoms
PhaseNA
TypeInterventional
Age18 Years – 65 Years
WhereBoston, Massachusetts, United States
SponsorMassachusetts General Hospital
▾Tap for detailsClick for full details — eligibility, all locations, contacts Study of ABX-002 for the Adjunctive Treatment of Major Depressive Disorder (AMPLIFY)
RecruitingThe goal of this clinical trial is to learn if ABX-002 added to an existing antidepressant treatment will benefit depression symptoms in adults with moderate to severe major depressive disorder who have had an inadequate response to their antidepressant. This is a double-blind, placebo-controlled, 2-arm, parallel-group, Phase 2 study, randomized 1:1 (ABX-002: placebo). The study will include the following stages: 1. Screening, approximately 35 days 2. 42-day Treatment Period 3. 2-week post dose Safety Follow-up Period 4. 6-month postdose targeted safety follow-up period
PhasePhase 2
TypeInterventional
Age18 Years – 65 Years
WhereBirmingham, Alabama, United States + 49 more
SponsorAutobahn Therapeutics, 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 Transcranial Near Infrared Radiation and Cerebral Blood Flow in Depression - R33
RecruitingThe purpose of this research study is to determine if application of near infrared energy to the forehead can change blood flow in the brains of people with depression. Near infrared energy is like light but is not visible to the human eye.
PhaseNA
TypeInterventional
Age18 Years – 65 Years
WhereBoston, Massachusetts, United States + 2 more
SponsorNYU Langone Health
▾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 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
WhereGilbert, Arizona, United States + 26 more
SponsorDefinium Therapeutics US, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts