A Study of Aticaprant 10 Milligrams (mg) as Adjunctive Therapy in Adult Participants With MDD With Moderate-to-severe Anhedonia and Inadequate Response to Current Antidepressant Therapy (VENTURA-2)
Last Updated   April 24, 2024 - 21:08
OVERVIEW
-
Gender
all -
Age
years -
Phase
phase 3The drug or treatment is given to large groups of people to confirm its effectiveness, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely. -
Sites
sites -
Status
Recruiting
SUMMARY
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 MDD with ANH+. The total duration of the study will be up to 87 days. Safety evaluation 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.
CONDITIONS
- Anhedonia
- Depressive disorder, major
ELIGIBILITY
Inclusion Criteria:
* Be medically stable on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening and baseline
* Have 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 (that is, an improvement of more than 20 percent [%] on their HDRS-17 total score) between the first and the second independent HDRS-17 assessments
* Meet 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 structural 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 age
* Is 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 (at or above the minimum therapeutic dose per Massachusetts General Hospital Antidepressant Treatment Response Questionnaire [MGH-ATRQ] for at least 6 weeks. The current antidepressant cannot be the first antidepressant treatment for the first lifetime episode of depression
* Participant's current major depressive episode, and antidepressant treatment response in the current depressive episode, must all be confirmed by the Site Independent Qualification Assessment
Exclusion Criteria:
* 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 MGH-ATRQ
* Has a history or evidence of clinically meaningful noncompliance with current antidepressant therapy
* Has a history of moderate-to-severe substance use disorder including alcohol use disorder according to diagnostic and statistical manual of mental disorders-5th edition (DSM-5) criteria within 6 months before screening
* Has had in the current episode an inadequate response to adequate course of intravenous or intranasal ketamine or esketamine, electroconvulsive therapy (that is, at least 7 treatments), vagal nerve stimulation, or deep brain stimulation device
* Has current, or a history (past 6 months), of seizures
* Has 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 (active suicidal ideation with some intent to act, without specific plan) or Item 5 (active suicidal ideation with specific plan and intent), 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 excluded
* Has one or more of the following diagnoses: a) A diagnostic and statistical manual of mental disorders-5th edition (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 major depressive disorder (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
DETAILS
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 MDD with ANH+. The total duration of the study will be up to 87 days. Safety evaluation 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.
LOCATIONS
Country (14) | City or Province (113) | Status |
United States | Allentown, PA Lehigh Center for Clinical Research |
RECRUITING
|
United States | Ann Arbor, MI Michigan Clinical Research Institute |
RECRUITING
|
United States | Austin, TX Donald J Garcia Jr MD PA |
RECRUITING
|
United States | Bellevue, WA Northwest Clinical Research Center |
RECRUITING
|
United States | Birmingham, AL University of Alabama at Birmingham |
RECRUITING
|
United States | Buffalo, NY Erie County Medical Center |
COMPLETED
|
United States | Charlotte, NC New Hope Clinical Research |
RECRUITING
|
United States | Colorado Springs, CO MCB Clinical Research Centers, LLC |
RECRUITING
|
United States | Columbus, OH Wexner Medical Center at the Ohio State University |
RECRUITING
|
United States | Coral Springs, FL CNS Clinical Research Group |
RECRUITING
|
United States | Dallas, TX Relaro Medical Trials |
RECRUITING
|
United States | Dallas, TX UT Southwestern Medical Center |
RECRUITING
|
United States | Edmond, OK Conrad Clinical Research |
RECRUITING
|
United States | Everett, WA Core Clinical Research |
COMPLETED
|
United States | Farmington Hills, MI Revive Research Institute |
RECRUITING
|
United States | Gainesville, FL Sarkis Clinical Trials |
RECRUITING
|
United States | Gaithersburg, MD CBH Health |
RECRUITING
|
United States | Lincoln, NE Premier Psychiatric Research Institute, LLC |
RECRUITING
|
United States | Maitland, FL K2 Medical Research |
RECRUITING
|
United States | Marrero, LA Tandem Clinical Research |
RECRUITING
|
United States | Miami, FL Ezy Medical Research |
RECRUITING
|
United States | Miami, FL Felicidad Medical Research |
RECRUITING
|
United States | Miami, FL Florida Research Center Inc. |
RECRUITING
|
United States | Miami, FL Global Medical Institutes |
RECRUITING
|
United States | Miami, FL LCC Medical Research Institute, Inc |
RECRUITING
|
United States | Miami, FL Vital Care Research |
RECRUITING
|
United States | Monroe, NC Monroe Biomedical Research |
RECRUITING
|
United States | Moosic, PA Global Medical Institutes |
RECRUITING
|
United States | Murray, UT Cedar Psychiatry |
RECRUITING
|
United States | New York, NY Manhattan Behavioral Medicine |
RECRUITING
|
United States | North Bay Village, FL Bravo Health Care Center |
RECRUITING
|
United States | Oklahoma City, OK Paradigm Research Professionals, LLC |
RECRUITING
|
United States | Oklahoma City, OK Sooner Clinical Research |
RECRUITING
|
United States | Orange, CA Pacific Neuropsychiatric Specialists |
RECRUITING
|
United States | Orlando, FL APG Research LLC |
COMPLETED
|
United States | Orlando, FL Combined Research Orlando |
RECRUITING
|
United States | Pompano Beach, FL Quantum Laboratories |
RECRUITING
|
United States | Port Saint Lucie, FL CDC Research Institute LLC |
RECRUITING
|
United States | Rancho Cucamonga, CA Prospective Research Innovations Inc |
RECRUITING
|
United States | Saint Charles, MO Midwest Research Group |
RECRUITING
|
United States | San Diego, CA University of California San Diego Medical Center |
RECRUITING
|
United States | Santee, CA CMB Clinical Trials |
RECRUITING
|
United States | Sherman Oaks, CA California Neuroscience Research |
COMPLETED
|
United States | Skokie, IL Psychiatric Medicine Associates |
RECRUITING
|
United States | Stafford, TX R and H Clinical Research |
RECRUITING
|
United States | West Covina, CA Next Level Clinical Trials, LLC |
RECRUITING
|
United Kingdom | Paisley, RFW Renfrewshire CMHT |
RECRUITING
|
United Kingdom | Southampton, HAM Moorgreen Hospital |
RECRUITING
|
Taiwan | Taichung China Medical University Hospital |
RECRUITING
|
Taiwan | Taipei Cheng Hsin General Hospital |
RECRUITING
|
Taiwan | Taipei Taipei Veterans General Hospital |
RECRUITING
|
Taiwan | Taipei City Taipei Medical University |
RECRUITING
|
South Korea | Bucheon-si, 41 Bucheon St. Mary's Hospital |
RECRUITING
|
South Korea | Busan Inje University Haeundae Paik Hospital |
RECRUITING
|
South Korea | Gyeonggi-do, 41 Korea University Ansan Hospital |
RECRUITING
|
South Korea | Seoul Korea University Anam Hospital |
RECRUITING
|
South Korea | Seoul KyungHee University Hospital |
RECRUITING
|
South Korea | Seoul Samsung Medical Center |
RECRUITING
|
South Korea | Seoul Seoul National University Hospital |
RECRUITING
|
South Korea | Seoul The Catholic University of Korea Yeouido St. Mary's Hospital |
RECRUITING
|
South Africa | Cape Town, WC Cape Town Clinical Research Centre |
RECRUITING
|
South Africa | Pretoria, GT Gert Bosch Pretoria South Africa |
RECRUITING
|
South Africa | Strand, WC Somerset West Clinical Research Unit |
RECRUITING
|
Slovakia | Banska Bystrica Psychomed-Svatosavsky, s.r.o. |
RECRUITING
|
Slovakia | Bojnice Nemocnica s poliklinikou Prievidza so sidlom v Bojniciach |
RECRUITING
|
Slovakia | Bratislava Psychiatricka Ambulancia Mentum S.R.O. |
RECRUITING
|
Slovakia | Koshice Epamed sro |
RECRUITING
|
Slovakia | Kosice Univerzitna nemocnica L. Pasteura Kosice |
RECRUITING
|
Slovakia | Liptovsky Mikulas Liptovska Nemocnica S Poliklinikou Mudr. Ivana Stodolu |
RECRUITING
|
Slovakia | Rimavska Sobota Psychiatricka Ambulancia Psycholine S.R.O. |
RECRUITING
|
Slovakia | Vranov nad Toplou Crystal Comfort s.r.o. |
RECRUITING
|
Poland | Bydgoszcz Clinsante Osrodek Badan Klinicznych |
RECRUITING
|
Poland | Katowice Centrum Medyczne Care Clinic Katowice |
RECRUITING
|
Poland | Poznan Filip Rybakowski Specjalistyczna Praktyka Lekarska |
RECRUITING
|
Poland | Suchy Las Indywidualna Specjalistyczna Praktyka Lekarska Agnieszka Remlinger Molenda |
RECRUITING
|
France | Bohars CHU de Brest - Hôpital de la Cavale Blanche |
RECRUITING
|
France | Clermont Ferrand CHU Clermont-Ferrand - Hopital Gabriel Montpied |
RECRUITING
|
France | Douai Cabinet Medical des Drs Prizac-Desbonnet Scottez |
RECRUITING
|
France | Nantes CHU de Nantes hotel Dieu |
RECRUITING
|
France | Paris Hopital Sainte Anne |
RECRUITING
|
France | Tours cedex 9 CHRU de Tours Clinique Psychiatrique Universitaire |
RECRUITING
|
Czechia | Brno Psychiatricka ambulance, MUDr. Marta Holanova |
COMPLETED
|
Czechia | Kutna Hora Neuroterapie KH, s.r.o. |
RECRUITING
|
Czechia | Praha 6 Medical Services Prague s.r.o. |
RECRUITING
|
Czechia | Praha 8 Institut Neuropsychiatricke pece |
RECRUITING
|
China | Baoding Hebei Mental Health Center |
RECRUITING
|
China | Beijing, 11 Beijing Anding Hospital of Capital Medical University |
RECRUITING
|
China | Beijing, 11 Beijing Huilongguan Hospital |
RECRUITING
|
China | Beijing, 11 Peking University Sixth Hospital |
RECRUITING
|
China | Guangzhou Guangdong Provincial People's Hospital |
RECRUITING
|
China | Hu Zhou Huzhou third people's Hospital |
RECRUITING
|
China | Shanghai, 31 Shanghai Mental Health Center |
RECRUITING
|
China | Shanghai, 31 Tongji Hospital of Tongji University |
RECRUITING
|
China | Shijiazhuang The First Hospital of Hebei Medical University |
RECRUITING
|
China | Tianjin, 12 Tianjin Anding Hospital |
RECRUITING
|
China | Wuhan Wuhan Mental Health Center |
RECRUITING
|
China | XI An XiAn Mental Healthcare Center |
RECRUITING
|
Canada | Sherbrooke, QC DIEX Recherche Sherbrooke Inc. |
RECRUITING
|
Bulgaria | Sofia DCC 'Sv. Vrach and Sv. Sv. Kuzma and Damyan', OOD |
RECRUITING
|
Bulgaria | Sofia MHC - Sofia, EOOD |
RECRUITING
|
Bulgaria | Sofia Medical Center Hera EOOD |
RECRUITING
|
Bulgaria | Sofia Medical Center Intermedica, OOD |
RECRUITING
|
Bulgaria | Varna, 03 Diagnostic Consulting Center Mladost - M Varna |
RECRUITING
|
Brazil | Curitiba, PR Trial Tech Tecnologia em Pesquisas com Medicamentos |
RECRUITING
|
Argentina | Ciudad Autonoma de Buenos Aires, B Fundacion para el Estudio y Tratamiento de las Enfermedades Mentales |
RECRUITING
|
Argentina | Cordoba CEN Consultorios Especializados en Neurociencias |
RECRUITING
|
Argentina | Cordoba Centro Medico Luquez |
RECRUITING
|
Argentina | Cordoba Instituto Medico DAMIC |
RECRUITING
|
Argentina | La Plata Clinica Privada de Salud Mental Santa Teresa de Ávila |
RECRUITING
|
Argentina | La Plata INSA Instituto de Neurociencias San Agustín |
RECRUITING
|
Argentina | Rosario C I A P Centro de investigacion y Asistencia en Psiquiatria |
RECRUITING
|
Argentina | San Miguel de Tucuman Clinica Mayo de UMCB |
RECRUITING
|
Argentina | Santiago del Estero Clinica El Jardin |
RECRUITING
|
Indicates 50+ sites in this region: click to zoom in.
Indicates 10+ sites in this region: click to zoom in.
Indicates < 10 sites in this region: click to zoom in.
Corresponds to individual site.