Last updated 6 days ago
Study to Assess the Effects of Oral NMRA-335140 Versus Placebo in Participants With Major Depressive Disorder
332 patients around the world
Available in Chile, Brazil
Neumora Therapeutics, Inc.
12Research sites
332Patients around the world
This study is for people with
Depression
Major depression
Requirements for the patient
To 65 Years
All Gender
Medical requirements
- Have a primary Diagnostic and Statistical Manual of Mental Disorders Fifth Edition Text Revised (DSM-5-TR) diagnosis of MDD without psychotic features confirmed by Structured Clinical Interview for DSM 5 Disorders, Clinical Trials Version (SCID 5 CT) at screening. This may be a first or recurrent episode.Participant's current major depressive episode must be confirmed by independent assessment.The symptoms of the current MDD episode have been present for more than 4 weeks prior to the Screening Visit, but no longer than 12 months prior to the Screening Visit.Have a MADRS total score of 25 or higher at Screening and Baseline.A change in MADRS total score between Screening and Baseline of ≤20%.
- Have failed 2 or more courses of antidepressant treatment at sufficient doses for at least 6 to 8 weeks for the current MDD episode.Currently or in the past year have been diagnosed with a personality disorder per DSM-5-TR or in the past 3 years have been diagnosed with any of the following DSM-5-TR disorders: anorexia nervosa, bulimia nervosa, or binge eating disorder.Participants with comorbid generalized anxiety disorder, social anxiety disorder, simple phobias, or panic disorder for whom MDD is considered the primary diagnosis are not excluded.Have a lifetime diagnosis of bipolar 1 or 2, schizophrenia, schizoaffective, schizophreniform, obsessive compulsive disorder, or post traumatic stress disorder (PTSD).Have moderate to severe substance or alcohol use disorder, per DSM-5-TR criteria, within the 12 months prior to screening excluding nicotine.Are actively suicidal. This includes any suicide attempts within the past 12 months or being at serious suicidal risk as indicated by any current suicidal intent, including a plan, as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS).Participants who are currently hospitalized for MDD symptoms or suicidality are not allowed into the study.If there is a recent history (within 3 months of screening) of hospitalization due to MDD symptoms, the participant should be discussed with the Medical Monitor for eligibility.
Sites
Fundação Faculdade Regional de Medicina de São José do Rio Preto
Recruiting
CPQuali Pesquisa Clínica
Recruiting
BR Trials - Pesquisa Clínica - Sao Paulo
Recruiting
Facili Centro Integrado de Saúde Mental
Recruiting
Hospital São Lucas da Pontifícia Universidade Católica do Rio Grande do Sul
Recruiting
Trial Tech Tecnologia Em Pesquisas com Medicamentos LTDA
Recruiting
Ruschel Medicina e Pesquisa Clínica
Recruiting
Biomedica Research Group
Recruiting
Centro de Investigaciones Clínicas UC - CICUC
Recruiting
Grupo CETEP - Balmoral, Las Condes
Recruiting
StudyNMRA-335140
SponsorNeumora Therapeutics, Inc.
Study typeInterventional
Conditions
Major depression
Requirements
To 65 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06058013
