Multicenter Study to Assess the Efficacy and Safety of LB-102 in the Treatment of Adult Patients With BP1MDE.
NCT07494305 · Bipolar I Disorder
RecruitingPhase 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.
PhasePhase 2
TypeInterventional
Age18 Years – 65 Years
WhereBentonville, Arkansas, United States + 25 more
SponsorLB Pharmaceuticals Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts The goal of this clinical trial is to learn if a drug called TNX-102 SL works to treat moderate to severe major depressive disorder in adults. It will also learn about the safety of TNX-102 SL. The main questions it aims to answer are: Does TNX-102 SL improve depression symptoms according to a depression symptom rating scale? What medical problems do participants have when taking TNX-102 SL? Researchers will compare TNX-102 SL to a placebo (a look-alike substance that contains no drug) to see if TNX-102 SL works to treat major depressive disorder. Participants will: Take TNX-102 SL or a placebo every night at bedtime for 6 weeks Visit the clinic once every 2 weeks for checkups and tests
PhasePhase 2
TypeInterventional
Age18 Years
WherePhoenix, Arizona, United States + 24 more
SponsorTonix Pharmaceuticals, Inc.
▾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 Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients
RecruitingThis is a multicenter, randomized, double-blind, placebo-controlled study in pediatric patients who are experiencing major depressive episodes (MDEs) associated with a primary diagnosis of bipolar I or bipolar II disorder as confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL), according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5).
PhasePhase 3
TypeInterventional
Age10 Years – 17 Years
WhereDothan, Alabama, United States + 58 more
SponsorIntra-Cellular Therapies, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Assess Change in Disease Activity and Adverse Events of Oral Icalcaprant in Adult Participants With Major Depressive Disorder
RecruitingMajor depressive disorder (MDD; depression) is a mood disorder that causes a continued feeling of sadness and loss of interest. It is a common and serious illness that can cause both emotional and physical symptoms such as feelings of sadness, irritability, not being able to focus on activities, tiredness, changes in eating habits, and aches and pains. This study will assess the changes in disease activity and adverse events of oral Icalcaprant in adult participants with major depressive disorder who are currently experiencing a major depressive episode (MDE). Icalcaprant is an investigational drug being developed for the treatment of depressive episodes in adult participants with major depressive disorder. Participants are placed in 1 of 3 groups, called treatment arms. There is a 1 in 3 chance that a participant will be assigned to placebo treatment. Around 195 adult participant with major depressive disorder will be enrolled in approximately 35 sites in North America. Participants will receive oral capsules of Icalcaprant or matching placebo once daily for 6 weeks, with a 30-day safety follow-up. There may be a higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
PhasePhase 2
TypeInterventional
Age18 Years – 65 Years
WhereDothan, Alabama, United States + 32 more
SponsorAbbVie
▾Tap for detailsClick for full details — eligibility, all locations, contacts The purpose of this study is to determine efficacy differences between ALTO-300 and placebo, used adjunctively to an antidepressant, related to patient characteristics.
PhasePhase 2
TypeInterventional
Age18 Years – 70 Years
WherePhoenix, Arizona, United States + 44 more
SponsorAlto Neuroscience
▾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 A Phase 2 Study of 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 zelquistinel1)? 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
WherePhoenix, Arizona, United States + 31 more
SponsorSyndeio Biosciences, Inc
▾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 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 Exercise Training for Managing Major Depressive Disorder in Multiple Sclerosis
RecruitingThe purpose of this research is to examine the effects of two different exercise training regimens for managing depression and improving other health indicators among persons with multiple sclerosis (MS). The project will enroll persons with MS and major depressive disorder (MDD) between 18 and 64 years of age. The investigators will enroll a total of 146 participants. This is a Phase-II trial that compares the efficacy of an exercise training program (POWER-MS) compared with a stretching program (FLEX-MS) for immediate and sustained reductions in the severity of depression among persons with MS who have MDD.
PhaseNA
TypeInterventional
Age18 Years – 64 Years
WhereChicago, Illinois, United States
SponsorUniversity of Illinois at Chicago
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Assess the Efficacy, Safety and Tolerability of VLS-01 Buccal Film, Compared to Placebo in Patients With Treatment Resistant Depression (ELUMINA)
RecruitingThis Phase 2 study (protocol number VLS-01-203) will determine the efficacy, safety, and tolerability of short-term treatment with a VLS-01 transmucosal buccal film (VLS-01-BU) in patients with treatment resistant Major Depressive disorder (TRD) and will characterize the onset and durability of antidepressant effects of VLS-01-BU versus placebo.
PhasePhase 2
TypeInterventional
Age18 Years – 65 Years
WhereTucson, Arizona, United States + 47 more
Sponsoratai Therapeutics, Inc.
▾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 determine the efficacy, safety and tolerability of CYB003 compared to matching placebo as adjunctive treatment in patients with MDD. For more information about the EMBRACE study, including participating study locations, and to register your interest in learning more about participation, please visit the study website: https://embrace-mdd-trial.com/
PhasePhase 3
TypeInterventional
Age18 Years – 85 Years
WhereBirmingham, Alabama, United States + 66 more
SponsorCybin IRL Limited
▾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 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 + 45 more
SponsorXenon Pharmaceuticals Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts Evaluation of Efficacy and Safety of Milsaperidone as Adjunctive Therapy in Patients With Major Depressive Disorder
RecruitingThe purpose of this study is to determine the efficacy and safety of milsaperidone compared to placebo as adjunctive therapy in patients with Major Depressive Disorder
PhasePhase 3
TypeInterventional
Age18 Years – 65 Years
WherePhoenix, Arizona, United States + 37 more
SponsorVanda Pharmaceuticals
▾Tap for detailsClick for full details — eligibility, all locations, contacts Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services
NCT06740383 · Schizophrenia Spectrum and Other Psychotic Disorders, Schizophrenia, Delusional Disorder
RecruitingThe Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services (BICEPS) study aims to understand the early stages of psychotic disorders like Schizophrenia, Schizoaffective Disorder, and Bipolar I Disorder. It involves gathering mental health information, brain scans (MRI), eye movement patterns (Eye-Tracking), and brain electrical waves (EEG) data from individuals who have experienced these disorders in recent years. Participants will be involved for about a year, with four visits over this period. Screening procedures, lasting approximately 3 hours, include tests for drug use, a pregnancy test for eligible women, clinical interviews about feelings and experiences, psychiatric and family history interviews, and a medical history review. Research procedures for eligible participants include DNA collection, a neuropsychological test battery, EEG, eye-tracking, and MRI. These procedures will help researchers understand brain function, genetics, and cognitive abilities related to psychotic disorders. Follow-up visits at 1-month, 6-month, and 12-month intervals involve modified clinical interviews and repeating neuropsychological tests to track changes over time. Participants may opt to provide DNA samples for genetic analysis, undergo various cognitive tests, EEG to record brain waves, eye-tracking to monitor eye movements, and MRI scans to visualize brain structure. Follow-up visits at regular intervals will help researchers track changes in symptoms and cognitive function. This study provides comprehensive insight into the onset and progression of psychotic disorders and offers valuable information for patients, families, and healthcare providers involved in managing these conditions. Our goal is to better understand whether a combination of biological markers and different types of people (BT1, BT2, BT3) can help us predict how well individuals with early psychosis respond to specialized care. We expect that those in BT3 will have the best outcomes, BT2 will have intermediate outcomes, and BT1 will have the poorest outcomes. Even though BT1 and BT2 might start with similar cognitive issues, their biology might lead to different responses to treatment. This research can help us understand which treatments work best for different people with early psychosis.
Phase—
TypeObservational
Age18 Years – 40 Years
WhereHartford, Connecticut, United States + 5 more
SponsorBeth Israel Deaconess Medical Center
▾Tap for detailsClick for full details — eligibility, all locations, contacts Mood Effects of Serotonin Agonists: Depression
RecruitingThis study will examine the effect of a low dose of the 5HT2A agonist LSD (26 µg), compared to placebo, on acute and protracted mood states in individuals with depression. The investigators will assess the relationship between mood-related symptoms and EEG as a neurophysiological marker.
PhaseEARLY_Phase 1
TypeInterventional
Age18 Years – 40 Years
WhereChicago, Illinois, United States
SponsorUniversity of Chicago
▾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