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A Study of Aticaprant as Adjunctive Therapy in Adult Participants With Major Depressive Disorder (MDD) With Moderate-to-severe Anhedonia and Inadequate Response to Current Antidepressant Therapy
538 patients around the world
Available in Brazil, Argentina
Depression is a common and serious psychiatric disorder which is a leading cause of
disability worldwide and is associated with elevated mortality and suicide risk.
Aticaprant (JNJ-67953964) is a once daily, highly selective kappa opioid receptor (KOR)
antagonist, with demonstrated selectivity over mu opioid receptor (MOR) and delta opioid
receptor (DOR) being developed for adjunctive treatment of major depressive disorder
(MDD) with moderate-to-severe anhedonia (ANH+). The study consists of a screening phase
(up to 30 days prior to randomization), double-blind treatment phase (43 days), and
follow-up phase (up to 14 days). The total duration of the study will be up to 87 days.
Safety evaluations including adverse events, physical examinations, urine drug test,
alcohol breath tests, and clinical laboratory tests will be assessed at specific time
points during this study.
Janssen Research & Development, LLC
16Research sites
538Patients around the world
This study is for people with
Depression
Major depression
Requirements for the patient
To 74 Years
All Gender
Medical requirements
- Be medically stable on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening and baselineHave a Hamilton Depression Rating Scale 17 item (HDRS-17) total score of 20 or higher at the first and second screening interviews and must not demonstrate a clinically significant improvement between the first and the second independent HDRS-17 assessmentsMeet Diagnostic and Statistical Manual of Mental Disorders-5th edition (DSM-5) diagnostic criteria for recurrent or single episode major depressive disorder (MDD), without psychotic features, based upon clinical assessment and confirmed by the structured clinical interview for DSM-5 Axis I disorders-clinical trials version (SCID-CT). Participants 65 years of age or older must have had the first onset of depression prior to 55 years of ageHave had an inadequate response to at least 1 oral antidepressant treatment, administered at an adequate dose (at or above the minimum therapeutic dose per Massachusetts General Hospital Antidepressant Treatment Response Questionnaire [MGH ATRQ]) and duration (at least 6 weeks) in the current episode of depression. An inadequate response is defined as less than(<) 50% reduction in depressive symptom severity but with some improvement (>0%) (ie, there may be minimal to moderate symptomatic improvement since the initiation of treatment, but some of the initial symptoms are still present, troubling to the participant and affecting behavior and function), as assessed by the MGH ATRQIs currently receiving and tolerating well any one of the following selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI) for depressive symptoms at screening, in any approved formulation and available in the participating country/territory: citalopram, duloxetine, escitalopram, fluvoxamine, fluoxetine, milnacipran, levomilnacipran, paroxetine, sertraline, venlafaxine, desvenlafaxine at a stable dose for at least 6 weeks. The current antidepressant cannot be the first antidepressant treatment for the first lifetime episode of depressionParticipant's current major depressive episode, and antidepressant treatment response in the current depressive episode, must all be confirmed by the site independent qualification assessment
- Have had in the current depressive episode, no response (treatment failure) to 5 or more antidepressant treatments including the current SSRI/SNRI (that is, the one presumed to be continued in the treatment phase) assessed using the Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (MGH ATRQ)Has a history or evidence of clinically meaningful noncompliance with current antidepressant therapyHas a history of moderate-to-severe substance use disorder including alcohol use disorder according to DSM-5 criteria within 6 months before screeningHas had in the current episode an inadequate response to adequate course of intravenous or intranasal ketamine or esketamine, electroconvulsive therapy, vagal nerve stimulation, or deep brain stimulation deviceHas current, or a history (past 6 months), of seizuresHas a current homicidal ideation/intent, per the investigator's clinical judgment, or has suicidal ideation with some intent to act within 3 months prior to the start of the Screening Phase, per the investigator's clinical judgment or based on the Columbia Suicide Severity Rating Scale (C-SSRS), corresponding to a response of "Yes" on Item 4 or Item 5, or a history of suicidal behavior within the past 6 months prior to the start of the Screening Phase. Participants reporting suicidal ideation with intent to act or suicidal behavior at baseline should be excludedHas one or more of the following diagnoses: a) A DSM-5 diagnosis (which has been the primary focus of psychiatric treatment within the past 2 years) of any of the following: panic disorder, generalized anxiety disorder, social anxiety disorder, specific phobia; b) A current (in the past year) DSM-5 diagnosis of: obsessive-compulsive disorder (OCD), post-traumatic stress disorder (PTSD), anorexia nervosa, bulimia nervosa; c) A current or prior (lifetime) DSM-5 diagnosis of: a psychotic disorder or MDD with psychotic features, bipolar or related disorders, intellectual disability, autism spectrum disorder, borderline personality disorder, antisocial personality disorder, histrionic personality disorder, narcissistic personality disorders, somatoform disorders
Sites
CENYDET Centro Neurobiológico y de Estrés Traumático (Biopsychomedical Research Group S.R.L.)
Recruiting
CIPREC Centro de Investigación y Prevención Cardiovascular - CABA
Recruiting
Instituto Modelo de Neurología Lennox
Recruiting
STAT Research - CABA
Instituto Médico de la Fundación Estudios Clínicos - Rosario
Recruiting
Hospital Italiano de Buenos Aires - CABA, Buenos Aires
Recruiting
CENPIA SA Centro de Estudio Neuropsiquiátrico Psicológico Integral Ambulatorio
Recruiting
Resolution Psychopharmacology Research Institute
Recruiting
CPQuali Pesquisa Clínica
Recruiting
Fundação Faculdade Regional de Medicina de São José do Rio Preto
Recruiting
StudyVENTURA-1
SponsorJanssen Research & Development, LLC
Study typeInterventional
Conditions
Major depression
Requirements
To 74 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05455684
