Circuit-Based Approach to Suicide: Biomarkers, Predictors, and Novel Therapeutics
NCT04130958 · Major Depressive Episode, Borderline Personality Disorder, Suicide
RecruitingThis neuroimaging study is a clinical trial investigating the effectiveness of intermittent theta-burst transcranial magnetic stimulation (iTBS-TMS) to the inferior parietal lobule (IPL) in reducing suicide risk in patients with major depressive episode (MDE) or borderline personality disorder (BPD).
PhaseNA
TypeInterventional
Age18 Years – 65 Years
WhereBoston, Massachusetts, United States
SponsorMassachusetts General Hospital
▾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 "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 + 45 more
SponsorCybin IRL Limited
▾Tap for detailsClick for full details — eligibility, all locations, contacts 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 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 Long-Term Study to Assess the Safety and Tolerability of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
RecruitingThis study will evaluate the long-term safety and tolerability of NBI-1065845 as an adjunctive treatment in participants with MDD.
PhasePhase 3
TypeInterventional
Age18 Years
WhereHuntsville, Alabama, United States + 86 more
SponsorNeurocrine Biosciences
▾Tap for detailsClick for full details — eligibility, all locations, contacts Transcranial Direct Current Stimulation (tDCS) Neuromodulation of Executive Function Across Neuropsychiatric Populations
NCT04296604 · Traumatic Brain Injury,
Major Depressive Disorder, Bipolar Disorder
RecruitingIn the current study, the investigators aim to understand the role of transcranial direct current stimulation (tDCS) in improving executive function across neuropsychiatric populations known to have deficits in this cognitive domain.
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 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 + 43 more
SponsorXenon Pharmaceuticals Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts Study to Assess the Safety and Effectiveness of NMRA-335140-501
RecruitingThis is a 52-week open-label extension (OLE) study that will evaluate the safety, tolerability, and effectiveness of NMRA-335140 in participants with major depressive disorder (MDD). Participants who completed a parent study investigating the efficacy and safety of NMRA-335140 as a treatment for MDD (ie, NMRA-335140-301, NMRA-335140-302, or NMRA-335140-303), and complete the 6 weeks double-blind treatment, provide informed consent, and meet eligibility criteria, may enter this extension study.
PhasePhase 3
TypeInterventional
Age18 Years – 65 Years
WhereHuntsville, Alabama, United States + 177 more
SponsorNeumora Therapeutics, Inc.
▾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 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 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 Targeting Specific Brain Networks to Treat Specific Symptoms in Depression
RecruitingRepetitive transcranial magnetic stimulation (rTMS) is a way of non-invasively stimulating specific brain networks and is an established treatment for Major Depressive Disorder (MDD). This proposal will reveal network mechanisms of the therapeutic effects of rTMS by investigating how stimulating each network specifically changes network connectivity and behavior. This will be done in a highly individualized manner in depressed and healthy patients, leading to more effective and more individualized treatments for depression.
PhaseNA
TypeInterventional
Age18 Years – 65 Years
WhereBoston, Massachusetts, United States
SponsorMassachusetts General Hospital
▾Tap for detailsClick for full details — eligibility, all locations, contacts Pramipexole Versus Escitalopram to Treat Major Depressive Disorder (MDD) and Comorbid MDD With Mild Neurocognitive Disorder (MND) in Persons With HIV
NCT06705478 ·
Major Depressive Disorder, Mild Neurocognitive Disorder, HIV
RecruitingA phase II, randomized, open-label, two-arm clinical trial evaluating the safety and efficacy of pramipexole extended release (ER) versus escitalopram for the treatment of major depressive disorder (MDD) and comorbid MDD with mild neurocognitive disorder (MND) in persons with HIV (PWH). Participants will be assessed comprehensively and briefly at intercurrent visits to monitor for toxicity, response to therapy, and to assess for dose changes. An optional sub-study to evaluate treatment impact on the cerebrospinal fluid (CSF) profile will be conducted in a subset of 36 participants.
PhasePhase 2
TypeInterventional
Age18 Years – 70 Years
WhereBirmingham, Alabama, United States + 40 more
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
▾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 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 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 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 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