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 Neurobehavioral Therapy For Epilepsy And Major Depressive Disorder
NCT06695767 · Major Depressive Disorder, Epilepsy
RecruitingThe purpose of this study is to examine the feasibility and acceptability of an online group Neuro-behavioral Therapy (NBT) with text messaging intervention for Veterans with epilepsy and major depressive disorder (MDD).
PhaseNA
TypeInterventional
Age18 Years
WhereHouston, Texas, United States + 1 more
SponsorThe University of Texas Health Science Center, Houston
▾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 "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 Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
NCT06786624 · Major Depressive Disorder
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 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 ACP-211 Monotherapy for Major Depressive Disorder With Inadequate Antidepressant Response
NCT07284667 · Major Depressive Disorder (MDD), Depressive Disorder, Treatment-Resistant
RecruitingThe goal of this clinical trial is to learn if ACP-211 can help treat adults with major depressive disorder (MDD) who have not improved with antidepressant therapy (ADT), including those with treatment resistant depression (TRD). The main questions the study aims to answer are: * Does ACP-211 work better than a placebo (a look-alike capsule with no medicine) to reduce symptoms of depression? * What adverse events do participants have when taking ACP-211?
PhasePhase 2
TypeInterventional
Age18 Years – 65 Years
WhereBirmingham, Alabama, United States + 12 more
SponsorACADIA 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 Self Neuro-modulation Therapy for Major Depressive Disorder (MDD) With Anhedonia
NCT06982820 · Depressive Disorder, Major
RecruitingThe purpose of this research is to learn more about a new treatment for individuals with Major Depressive Disorder (MDD) with heightened symptoms of anhedonia (i.e. loss of pleasure or interest in activities). The treatment is called Prism, and it is a software device intended for a novel form of neurofeedback training to be used in a clinic setting. During this study, the subject will use different techniques to measure brain activities, including magnetic resonance imaging (MRI) and electroencephalography (EEG).
PhaseNA
TypeInterventional
Age22 Years – 75 Years
WhereProvidence, Rhode Island, United States + 2 more
SponsorGrayMatters Health Ltd.
▾Tap for detailsClick for full details — eligibility, all locations, contacts DBS for Depression
NCT03437928 · Major Depressive Disorder
RecruitingThe goal of the study is to address the unmet need of TRD patients by identifying brain networks critical for treating depression and to use next generation precision DBS with steering capability to engage these targeted networks. The study's goal will be achieved through 3 specific aims: 1. Demonstrate device capability to selectively and predictably engage distinct brain networks 2. Delineate depression-relevant networks and demonstrate behavioral changes with network-targeted stimulation 3. Demonstrate that chronic DBS using steered, individualized targeting is feasible and safe for reducing depressive symptoms
PhaseNA
TypeInterventional
Age22 Years – 70 Years
WhereDallas, Texas, United States + 1 more
SponsorBaylor College of Medicine
▾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 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 Telehealth Behavioral Activation for Teens
NCT06273995 · Depression, Suicide and Self-harm, Depression in Adolescence
RecruitingBehavioral activation is one such empirically supported intervention. Derived from cognitive-behavioral therapy, a well-established treatment for depression, behavioral activation uses psychoeducation and skill-building to increase an individual's engagement in valued and enjoyable activities (e.g., socializing with family and friends, exercising, participating in a hobby) in order to improve depressive symptoms. Research has shown that behavioral activation is an effective intervention for depressed youth. Additionally, it has been shown as a promising intervention that can be conducted in a brief, virtual format and can be effectively implemented by both trained clinicians and trained, non-licensed interventionists. This project will provide Behavioral Activation for youth (12-17) experiencing depression or suicidal ideation who are currently enrolled in the Youth Depression Suicide Network study in Texas.
PhaseNA
TypeInterventional
Age12 Years – 18 Years
WhereHouston, Texas, United States
SponsorBaylor College of Medicine
▾Tap for detailsClick for full details — eligibility, all locations, contacts Zelquistinel or Placebo for the Reduction of Symptoms of Major Depressive Disorder
NCT06547489 · 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 Study to Assess the Safety and Effectiveness of NMRA-335140-501
NCT06029439 · Major Depressive Disorder
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 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