Long-Term Study to Assess the Safety and Tolerability of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
NCT06966401 · Major Depressive Disorder
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
WhereLittle Rock, Arkansas, United States + 17 more
SponsorNeurocrine Biosciences
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Explore the Efficacy of JNJ-89495120 in the Treatment of Major Depressive Disorder
NCT06785012 · Depressive Disorder, Major
RecruitingThe purpose of this study is to evaluate how well JNJ-89495120 works (anti-depressant effects) and how well it is tolerated as compared to placebo on reducing the symptoms of depression in participants with major depressive disorder (MDD).
PhasePhase 2
TypeInterventional
Age18 Years – 64 Years
WhereHuntsville, Alabama, United States + 43 more
SponsorJanssen Research & Development, LLC
▾Tap for detailsClick for full details — eligibility, all locations, contacts Glutamatergic Adaptation to Stress as a Mechanism for Anhedonia and Treatment Response With Ketamine
NCT05327699 · Major Depressive Disorder
RecruitingThe main purpose of this study is to investigate the effects of ketamine on decision-making and emotion processing in a sample of individuals diagnosed with Major Depressive Disorder (MDD).
PhaseEARLY_Phase 1
TypeInterventional
Age18 Years – 65 Years
WhereAtlanta, Georgia, United States
SponsorEmory University
▾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
WhereAtlanta, Georgia, United States + 5 more
SponsorJanssen Research & Development, LLC
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of the Efficacy and Safety of SP-624 in the Treatment of Adults With Major Depressive Disorder
NCT06254612 · Major Depressive Disorder
RecruitingThis is a Phase 2B clinical study evaluating the effectiveness and safety of SP-624 as compared to placebo in the treatment of adults with Major Depressive Disorder.
PhasePhase 2
TypeInterventional
Age18 Years – 65 Years
WherePhoenix, Arizona, United States + 49 more
SponsorSirtsei Pharmaceuticals, Inc.
▾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 + 39 more
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
▾Tap for detailsClick for full details — eligibility, all locations, contacts Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients
NCT06372964 · Bipolar Depression
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 Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
NCT05850689 · Major Depressive Disorder
RecruitingThis is a multicenter, randomized, double-blind, placebo-controlled parallel-group, fixed-dose study in patients with a primary diagnosis of MDD according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) who have an inadequate response to ongoing ADT.
PhasePhase 3
TypeInterventional
Age18 Years – 65 Years
WhereHuntsville, Alabama, United States + 59 more
SponsorIntra-Cellular Therapies, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts ALTO-100 in Bipolar Disorder With Depression (BD-D)
NCT06656416 · Bipolar Disorder I or II With a Major Depressive Episode
RecruitingThe purpose of this study is to assess antidepressant efficacy differences between ALTO-100 and placebo during the Double-Blind period in patients with bipolar disorder I or II with current major depressive episode, when used adjunctively to a mood stabilizer and/or atypical antipsychotic, related to patient characteristics. Additionally, safety, tolerability, and efficacy will be assessed in a subsequent open label treatment period.
PhasePhase 2
TypeInterventional
Age18 Years – 70 Years
WhereChandler, Arizona, United States + 26 more
SponsorAlto Neuroscience
▾Tap for detailsClick for full details — eligibility, all locations, contacts Leucine in Midlife Depression
NCT06580145 · Major Depression
RecruitingThe study aims to investigate the effects of a 6-week leucine challenge on brain chemistry, connectivity, and behavior in people with midlife depression. The researchers will compare the leucine and an active comparator arm (lysine) for 6 weeks.
PhasePhase 2
TypeInterventional
Age35 Years – 65 Years
WhereAtlanta, Georgia, United States
SponsorEmory University
▾Tap for detailsClick for full details — eligibility, all locations, contacts "A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder"
NCT06564818 · 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 A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder
NCT06793397 · Major Depressive Disorder (MDD), Depression in Adults, Depression - 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.
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 Study of ABX-002 for the Adjunctive Treatment of Major Depressive Disorder (AMPLIFY)
NCT06633016 · Major Depressive Disorder
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)
NCT07076407 · Major Depressive Disorder
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 + 41 more
SponsorXenon Pharmaceuticals Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Randomized Study of Azetukalner Versus Placebo in Major Depressive Disorder
NCT06775379 · 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 Treatment ResistAnt Depression Subcallosal CingulatE Network DBS (TRANSCEND)
NCT06423430 · Treatment Resistant Depression
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 + 27 more
SponsorAbbott Medical Devices
▾Tap for detailsClick for full details — eligibility, all locations, contacts JAK Signaling in Depression
NCT07003997 · Major Depressive Disorder
RecruitingThis study will test the hypothesis that Janus kinase (JAK) signaling is involved in major depression (MD) with high inflammation by determining whether its inhibition with baricitinib can improve functional connectivity in reward and motor circuits in association with improved motivation and motor function in MD patients enriched for high C-reactive protein (CRP) and anhedonia.
PhasePhase 2
TypeInterventional
Age25 Years – 55 Years
WhereAtlanta, Georgia, United States
SponsorEmory University
▾Tap for detailsClick for full details — eligibility, all locations, contacts The OBSERVE Protocol
NCT06725277 · Major Depression Disorder
RecruitingThis observational protocol is intended to provide long-term follow-up data on patients initiating or continuing treatment with either Spravato® or IV ketamine. This can provide us information on the patient acceptability and satisfaction, patterns of use, long-term effectiveness, and safety of the two approaches. This 5-year, 6-site study will enroll 450 total patients. The sites will comprise 3 academic medical centers and 3 community psychiatric practices.
Phase—
TypeObservational
AgeAny
WhereMilford, Connecticut, United States + 5 more
SponsorYale University
▾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
NCT06223880 · Major Depressive Disorder
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 Study to Assess Change in Disease Activity and Adverse Events of Oral Icalcaprant in Adult Participants With Major Depressive Disorder
NCT07276997 · 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 + 30 more
SponsorAbbVie
▾Tap for detailsClick for full details — eligibility, all locations, contacts