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| ID | Type | Description | Link |
|---|---|---|---|
| 67953964MDD3001 | Other Identifier | Janssen Research & Development, LLC | |
| 2022-000439-22 | EudraCT Number |
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The purpose of this study is to evaluate the efficacy of aticaprant compared with placebo as adjunctive therapy to an antidepressant in improving depressive symptoms in adult participants with major depressive disorder (MDD) with moderate-to-severe anhedonia (ANH+) who have had an inadequate response to current antidepressant therapy with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aticaprant | Experimental | Participants will receive aticaprant tablets orally once daily for 42 days during double-blind treatment phase in addition to the current antidepressant selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor (SSRI/SNRI) therapy. Participants who will complete the double-blind treatment phase (Day 43) may be eligible to participate in a separate 52-week open-label long-term safety study (67953964MDD3003). |
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| Placebo | Placebo Comparator | Participants will receive matching placebo orally once daily for 42 days during double-blind treatment phase in addition to their current antidepressant (SSRI/SNRI) therapy. Participants who will complete the double-blind treatment phase (Day 43) may be eligible to participate in a separate 52-week open-label long-term safety study (67953964MDD3003). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aticaprant | Drug | Aticaprant will be administered orally as tablets. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Day 43 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score | The MADRS is a clinician-rated scale designed to measure depression severity and detect changes due to antidepressant treatment. The scale consists of 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of symptoms). MADRS total score is the sum of scores from individual question items, which ranges from 0 to 60; higher scores represent a more severe condition. Negative change in MADRS total score indicates improvement. | Baseline (Day 1) to Day 43 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Day 43 in Dimensional Anhedonia Rating Scale (DARS) Total Score | The DARS is a 17-item self-report questionnaire that is designed to assess anhedonia in MDD across the 4 domains: hobbies, social activities, food/drink, and sensory experience. The DARS scale measures desire, motivation, effort, and consummatory pleasure. The DARS is rated on a 5-point Likert scale (0=not at all, 1=slightly, 2=moderately, 3=mostly, 4=very much) and responses are summed to generate the total score (ranges from 0 to 68). A lower total score is indicative of greater anhedonia. Positive changes in DARS total score indicate improvement. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SW Biomedical Research LLC | Tucson | Arizona | 85712 | United States | ||
| University of Arizona |
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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Adult participants aged 18 to 64 years who had major depressive disorder (MDD) with or without moderate-to-severe anhedonia (ANH+ or ANH-) and elderly participants aged 65 to 74 years with MDD (ANH+ and ANH-) who had an inadequate response to an ongoing antidepressant therapy were randomized in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | During DB treatment phase, participants received placebo matching to aticaprant tablet orally once daily from Day 1 to Day 42 in addition to the ongoing antidepressant therapy (selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor [SSRI/SNRI]). Participants were then followed up for safety up to 7 to 14 days after end of DB phase at Day 43 (up to Day 57). Participants who completed the DB phase (at Day 43) and were compliant to the study intervention were eligible to participate in a separate 52-week open-label long-term safety study 67953964MDD3003 (NCT05518149). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 26, 2024 | Sep 16, 2025 |
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| Placebo | Other | Placebo will be administered orally as tablets. |
|
| Baseline (Day 1) to Day 43 |
| Change From Baseline Over Time in MADRS Total Score | Change from baseline over time in MADRS total score is reported. The MADRS is a clinician-rated scale designed to measure depression severity and detect changes due to antidepressant treatment. The scale consists of 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of symptoms). MADRS total score is the sum of scores from individual question items, which ranges from 0 to 60; higher scores represent a more severe condition. Negative change in MADRS total score indicates improvement. | Baseline (Day 1), Days 15, 29 and 43 |
| Percentage of Participants Who Achieved Response on Depressive Symptoms Scale Based on MADRS Total Score at Day 43 | Percentage of participants who achieved response on depressive symptoms scale based on MADRS total score at Day 43 are reported. Responders are defined as participants with a >=50 percent (%) improvement in the MADRS total score from baseline to a given timepoint. The MADRS is a clinician-rated scale designed to measure depression severity and detect changes due to antidepressant treatment. The scale consists of 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of symptoms). MADRS total score is the sum of scores from individual question items, which ranges from 0 to 60; higher scores represent a more severe condition. | At Day 43 |
| Percentage of Participants With Remission of Depressive Symptoms Based on MADRS Total Score at Day 43 | Percentage of participants with remission of depressive symptoms based on MADRS total score at Day 43 is reported. Participant is defined as a remitter at a given time point if the MADRS total score is less than or equal to (<=)10 at that time point. The MADRS is a clinician-rated scale designed to measure depression severity and detect changes due to antidepressant treatment. The scale consists of 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of symptoms). MADRS total score is the sum of scores from individual question items, which ranges from 0 to 60; higher scores represent a more severe condition. | At Day 43 |
| Change From Baseline to Day 43 in Patient Health Questionnaire, 9-Item (PHQ-9) Total Score | Change from baseline to Day 43 in PHQ-9 total score is reported. The PHQ-9 is a 9-item, participant reported outcome measure to assess depressive symptoms. The scale scores each of the 9 symptom domains of the Diagnostic and Statistical Manual of Mental Disorders-5th Edition (DSM-5) MDD criteria. Each item is rated on a 4 point scale (0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day). The participant's item responses are summed to provide a total score (range of 0 to 27), with higher scores indicating greater severity of depressive symptoms. The severity of the PHQ-9 is categorized as follows: none-minimal (0-4), mild (5-9), moderate (10-14), moderately severe (15-19) and severe (20-27). Negative changes in PHQ-9 total score indicate improvement. | Baseline (Day 1) to Day 43 |
| Change From Baseline Over Time in DARS Total Score | Change from baseline over time in DARS total score is reported. The DARS is a 17-item self-report questionnaire that is designed to assess anhedonia in MDD across the 4 domains: hobbies, social activities, food/drink, and sensory experience. The DARS scale measures desire, motivation, effort, and consummatory pleasure. The DARS is rated on a 5-point Likert scale (0=not at all, 1=slightly, 2=moderately, 3=mostly, 4=very much) and responses are summed to generate the total score (range of 0 to 68). A lower total score is indicative of greater anhedonia. Positive changes in DARS total score indicate improvement. | Baseline (Day 1), Days 15, 29, and 43 |
| Change From Baseline Over Time in the PHQ-9 Anhedonia-specific Item (PHQ-9, Item 1) | Change from baseline over time in the PHQ-9 anhedonia-specific item (PHQ-9, item 1 is little interest or pleasure in doing things) is reported. The PHQ-9 is a 9-item, participant reported outcome measure to assess depressive symptoms. The scale scores each of the 9 symptom domains of the Diagnostic and Statistical Manual of Mental Disorders-5th Edition (DSM-5) MDD criteria. Each item is rated on a 4 point scale (0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day). The participant's item responses are summed to provide a total score (range of 0 to 27), with higher scores indicating greater severity of depressive symptoms. The severity of the PHQ-9 is categorized as follows: none-minimal (0-4), mild (5-9), moderate (10-14), moderately severe (15-19) and severe (20-27). Negative changes in PHQ-9 total score indicate improvement. | Baseline (Day 1), Day 15, Day 29, and Day 43 |
| Percentage of Participants With a Score Less Than (<) 2 in the PHQ-9 Anhedonia-specific Item (PHQ-9, Item 1) at Day 43 | Percentage of participants with a score <2 in the PHQ-9 anhedonia-specific item (PHQ-9, item 1 is little interest or pleasure in doing things) at Day 43 is reported. The PHQ-9 is a 9-item, participant reported outcome measure to assess depressive symptoms. The scale scores each of the 9 symptom domains of the Diagnostic and Statistical Manual of Mental Disorders-5th Edition (DSM-5) MDD criteria. Each item is rated on a 4 point scale (0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day). The participant's item responses are summed to provide a total score (range of 0 to 27), with higher scores indicating greater severity of depressive symptoms. The severity of the PHQ-9 is categorized as follows: none-minimal (0-4), mild (5-9), moderate (10-14), moderately severe (15-19) and severe (20-27). | At Day 43 |
| Change From Baseline Over Time in Patient Reported Outcomes Measurement Information System Short Form - Ability to Participate in Social Roles and Activities - 8a (PROMIS-APS 8a) | Change from baseline over time in the PROMIS-APS 8a is reported. This 8-item measure assesses participants' ability to participate in social roles and activities. The items measures the degree of involvement in social roles, activities, and responsibilities, including work, family, friends, and leisure. Each item is rated on a 5-point ordinal scale including 1=always, 2=usually, 3=sometimes, 4=rarely and 5=never, with higher scores indicating better social functioning. The total scores of PROMIS-APS 8a ranges from 8 to 40 and is transformed using a T-score metric with a mean of 50 and a standard deviation of 10. T-score ranges from 25.9 to 65.4, a higher score indicates better social functioning. Positive change in score indicates improvement. | Baseline (Day 1), Days 15, 29, and 43 |
| Percent Change From Baseline Over Time in Work Productivity and Activity Impairment: Depression (WPAI:D) | The WPAI:D questionnaire is a validated short instrument that assesses impairment in work and other regular activities over the past 7 days. The WPAI yields four types of scores: (a) Absenteeism (work time missed); (b) Presenteeism (impairment at work / reduced on-the-job effectiveness); (c) Work productivity loss (overall work impairment / absenteeism plus presenteeism); (d) Activity Impairment. The first three scores are derived only for respondents who were working (should be missing for non-working), but the last score is applicable for all respondents. Each score ranges from 0 to 100 with higher scores indicating greater impairment and less productivity. Negative changes in score indicates less impairment and greater productivity. | Baseline (Day 1), Days 29 and 43 |
| DB Treatment Phase: Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) | Percentage of participants with TEAEs during DB treatment phase are reported. A TEAE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. A TEAE does not necessarily have a causal relationship with the intervention. TEAEs included both serious and non serious adverse events. TEAEs were defined as AEs with onset during the DB Treatment Phase, or AEs that are a consequence of a pre-existing condition that has worsened since baseline (Day 1). | From start of treatment (Day 1) up to Day 43 |
| Follow-up (FU) Phase: Percentage of Participants With AEs | An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. | From Day 44 up to Day 57 |
| Tucson |
| Arizona |
| 85713 |
| United States |
| Advanced Research Center Inc | Anaheim | California | 92805 | United States |
| Proscience Research Group | Culver City | California | 90230 | United States |
| Behavioral Research Specialists LLC | Glendale | California | 91206 | United States |
| Asclepes Research | Long Beach | California | 90807 | United States |
| Excell Research Inc | Oceanside | California | 92056 | United States |
| Syrentis Clinical Research | Santa Ana | California | 92705 | United States |
| Viking Clinical Research Ltd | Temecula | California | 92591 | United States |
| University of Connecticut Health Center | Farmington | Connecticut | 06030 | United States |
| Innovative Research of West Florida, Incorporated | Clearwater | Florida | 33756 | United States |
| Vertex Research Group, Inc | Clermont | Florida | 34711 | United States |
| Gulfcoast Medical Research Center | Fort Myers | Florida | 33912 | United States |
| New Life Medical Research Center, Inc. | Hialeah | Florida | 33012 | United States |
| Amedica Research Institute Inc | Hialeah | Florida | 33013 | United States |
| Convenient Medical Center | Hialeah | Florida | 33013 | United States |
| Galiz Research | Hialeah | Florida | 33016 | United States |
| Pharmax Research Clinic Inc | Miami | Florida | 33126 | United States |
| A Plus Research | Miami | Florida | 33144 | United States |
| Meridian International Research | Miami Gardens | Florida | 33014 | United States |
| University of Miami | Miami Lakes | Florida | 33016 | United States |
| Medical Research Group of Central Florida | Orange City | Florida | 32763 | United States |
| USF, Department of Psychiatry and Behavioral Neurosciences | Tampa | Florida | 33613 | United States |
| Research Network America | Berwyn | Illinois | 60402 | United States |
| Chicago Research Center | Chicago | Illinois | 60634 | United States |
| University of Kansas Medical Center Research Institute | Kansas City | Kansas | 66160 | United States |
| Clinical Trials of America | Monroe | Louisiana | 71203 | United States |
| ActivMed Practices and Research | Methuen | Massachusetts | 01844 | United States |
| Psychiatric Care and Research Center (PCRC) | O'Fallon | Missouri | 63368 | United States |
| Bioscience Research LLC | Mount Kisco | New York | 10549 | United States |
| Fieve Clinical Research Inc | New York | New York | 10168 | United States |
| Finger Lakes Clinical Research | Rochester | New York | 14618 | United States |
| Montefiore Medical Center PRIME | The Bronx | New York | 10467 | United States |
| Patient Priority Clinical Sites LLC | Cincinnati | Ohio | 45215 | United States |
| University of Cincinnati Medical Center | Cincinnati | Ohio | 45219 | United States |
| Midwest Clinical Research Center | Dayton | Ohio | 45417 | United States |
| Charak Center for Health and Wellness | Garfield Heights | Ohio | 44125 | United States |
| Suburban Research Associates | Media | Pennsylvania | 19063 | United States |
| University of Pennsylvania - Perelman School of Medicine | Philadelphia | Pennsylvania | 19104 | United States |
| West Houston Clinical Research Service | Bellaire | Texas | 77401 | United States |
| North Texas Clinical Trials | Fort Worth | Texas | 76104 | United States |
| Bay Area Clinical Services | Friendswood | Texas | 77546 | United States |
| Clinical Trial Network - Houston | Houston | Texas | 77074 | United States |
| Alpine Research Organization | Clinton | Utah | 84015 | United States |
| University of Virginia | Charlottesville | Virginia | 22903 | United States |
| Northwest Clinical Research Center | Bellevue | Washington | 98007 | United States |
| Hospital Italiano | Buenos Aires | 1199 | Argentina |
| STAT Research S A | Buenos Aires | C1013AAB | Argentina |
| CIPREC | Buenos Aires | C1061AAS | Argentina |
| CENydET - Centro Neurobiologico y de Stress Traumatico | Ciudad Autonoma Buenos Aires | 1058 AAJ | Argentina |
| Fundacion Lennox | Córdoba | 5000 | Argentina |
| CENPIA | La Plata | 1902 | Argentina |
| Resolution | Mendoza | M5502AHV | Argentina |
| Instituto Medico de La Fundacion Estudios Clinicos | Rosario | S2000DEJ | Argentina |
| Peninsula Therapeutic & Research Group | Frankston | 3199 | Australia |
| Albert Road Clinic | Melbourne | 3004 | Australia |
| The Alfred Hospital | Melbourne | 3004 | Australia |
| Anima | Alken | 3570 | Belgium |
| C.H.U. Brugmann | Brussels | 1020 | Belgium |
| Pz Duffel | Duffel | 2570 | Belgium |
| Vitaz | Sint-Niklaas | 9100 | Belgium |
| Universidade Federal do Ceara Hospital Universitario Walter Cantidio | Fortaleza | 60430-370 | Brazil |
| Instituto Goiano de Neuropsiquiatria | Goiânia | 74093 040 | Brazil |
| NPCRS Nucleo de Pesquisa Clinica do Rio Grande do Sul | Porto Alegre | 90430001 | Brazil |
| Ruschel Medicina e Pesquisa Clínica Ltda | Rio de Janeiro | 22270 060 | Brazil |
| CEMEC - Centro Multidisciplinar de Estudos Clínicos | São Bernardo do Campo | 09715-090 | Brazil |
| Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base | São José do Rio Preto | 15090-000 | Brazil |
| CPQuali Pesquisa Clinica LTDA ME | São Paulo | 01228-900 | Brazil |
| BR Trials | São Paulo | 05003 020 | Brazil |
| Ambulatory for Individual Practice for Specialized Medical Care in Psychiatry Dr. Ivo Natsov ET | Cherven Bryag | 5980 | Bulgaria |
| Ambulatory Group practice for specialized help in psychiary Philipopolis ODD | Plovdiv | 4002 | Bulgaria |
| Medical Center Mentalcare OOD | Plovdiv | 4004 | Bulgaria |
| Mental Health Center - Rousse | Rousse | 7003 | Bulgaria |
| Medical Center St. Naum | Sofia | 1113 | Bulgaria |
| Mental Health Center - Veliko Tarnovo EOOD | Veliko Tarnovo | 5000 | Bulgaria |
| Narodni ustav dusevniho zdravi | Klecany | 25067 | Czechia |
| A Shine S R O | Pilsen | 301 00 | Czechia |
| Clintrial s r o | Prague | 100 00 | Czechia |
| AD71 s.r.o. | Prague | 109 00 | Czechia |
| Praglandia s r o | Prague | 15000 | Czechia |
| NeuropsychiatrieHK, s.r.o. | Prague | 160 00 | Czechia |
| Psychiatricka ordinace | Ústí nad Labem | 400 01 | Czechia |
| Obudai Egeszsegugyi Centrum Kft | Budapest | 1036 | Hungary |
| Semmelweis Egyetem | Budapest | 1083 | Hungary |
| Nyiro Gyula Korhaz | Budapest | 1135 | Hungary |
| Bugat Pal Korhaz | Gyöngyös | 3200 | Hungary |
| Dr Mathe es Tarsa Bt | Kalocsa | 6300 | Hungary |
| PsychoTech Kft | Pécs | 7633 | Hungary |
| Tolna Megyei Balassa Janos Korhaz | Szekszárd | 7100 | Hungary |
| Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII) | Bergamo | 24127 | Italy |
| Azienda Ospedaliero Universitaria Mater Domini | Catanzaro | 88100 | Italy |
| AUSL LE di Lecce | Lecce | 73100 | Italy |
| Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico | Milan | 20122 | Italy |
| ASST Fatebenefratelli Sacco | Milan | 20157 | Italy |
| Ospedale San Raffaele | Milan | Italy |
| Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria alle Scotte | Siena | 53100 | Italy |
| Gabinet Lekarski Psychiatryczny Ireneusz Kaczorowski | Bełchatów | 97-400 | Poland |
| Mlynowamed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna Lazarczyk | Bialystok | 15-404 | Poland |
| Centrum Badan Klinicznych PI House sp z o o | Gdansk | 80 546 | Poland |
| Specjalistyczna Indywidualna Praktyka Lekarska | Lodz | 90-009 | Poland |
| SPZOZ Uniwersytecki Szpi.Klin. nr 4 UM w Lodzi | Lodz | 92-215 | Poland |
| Osrodek Badan Klinicznych CROMED | Poznan | 61-360 | Poland |
| Specjalistyczny Gabinet Psychiatryczny Kowalkowski Gerard | Torun | 87 100 | Poland |
| Hospital de Braga | Braga | 4710-243 | Portugal |
| Hospital CUF Inf. Santo | Lisbon | 1350 179 | Portugal |
| Fund. Champalimaud | Lisbon | 1400 038 | Portugal |
| Institucion Hosp Hestia Palau | Barcelona | 08025 | Spain |
| Hosp Univ Vall D Hebron | Barcelona | 08035 | Spain |
| Hosp Clinic de Barcelona | Barcelona | 08036 | Spain |
| Hosp. Univ. La Paz | Madrid | 28046 | Spain |
| Hosp Regional Univ de Malaga | Málaga | 29011 | Spain |
| Hosp. Univ. Son Espases | Palma de Mallorca | 07120 | Spain |
| Hosp. El Bierzo | Ponferrada | 24404 | Spain |
| Corporacio Sanitari Parc Tauli | Sabadell | 08208 | Spain |
| Hosp. Alvaro Cunqueiro | Vigo | 36312 | Spain |
| Hosp. Psiquiatrico Alava | Vitoria-Gasteiz | 01006 | Spain |
| Sahlgrenska Universitetssjukhuset | Gothenburg | 416 85 | Sweden |
| ProbarE i Lund AB | Lund | 22222 | Sweden |
| ProbarE i Stockholm AB | Stockholm | 113 29 | Sweden |
| Studieenheten Akademiskt Specialistcentrum Stockholm | Stockholm | 113 61 | Sweden |
| FG001 | Aticaprant 10 mg | During DB treatment phase, participants received aticaprant 10 mg tablet orally once daily from Day 1 to Day 42 in addition to the ongoing antidepressant therapy (SSRI/SNRI). Participants were then followed up for safety up to 7 to 14 days after end of DB phase at Day 43 (up to Day 57). Participants who completed the DB phase (at Day 43) and were compliant to the study intervention were eligible to participate in a separate 52-week open-label long-term safety study 67953964MDD3003 (NCT05518149). |
| Safety Analysis Set |
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| Participants Who Entered Follow-up Phase |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
Safety analysis set included all randomized participants (adults and elderly) who took at least 1 dose of study intervention.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | During DB treatment phase, participants received placebo matching to aticaprant tablet orally once daily from Day 1 to Day 42 in addition to the ongoing antidepressant therapy (SSRI/SNRI). Participants were then followed up for safety up to 7 to 14 days after end of DB phase at Day 43 (up to Day 57). Participants who completed the DB phase (at Day 43) and were compliant to the study intervention were eligible to participate in a separate 52-week open-label long-term safety study 67953964MDD3003 (NCT05518149). |
| BG001 | Aticaprant 10 mg | During DB treatment phase, participants received aticaprant 10 mg tablet orally once daily from Day 1 to Day 42 in addition to the ongoing antidepressant therapy (SSRI/SNRI). Participants were then followed up for safety up to 7 to 14 days after end of DB phase at Day 43 (up to Day 57). Participants who completed the DB phase (at Day 43) and were compliant to the study intervention were eligible to participate in a separate 52-week open-label long-term safety study 67953964MDD3003 (NCT05518149). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Change From Baseline to Day 43 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score | The MADRS is a clinician-rated scale designed to measure depression severity and detect changes due to antidepressant treatment. The scale consists of 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of symptoms). MADRS total score is the sum of scores from individual question items, which ranges from 0 to 60; higher scores represent a more severe condition. Negative change in MADRS total score indicates improvement. | Full analysis set (ANH+) included all adult randomized participants with MDD ANH+ who received at least 1 dose of study intervention. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure. | Posted | Least Squares Mean | Standard Error | Units on a scale | Baseline (Day 1) to Day 43 |
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| Secondary | Change From Baseline to Day 43 in Dimensional Anhedonia Rating Scale (DARS) Total Score | The DARS is a 17-item self-report questionnaire that is designed to assess anhedonia in MDD across the 4 domains: hobbies, social activities, food/drink, and sensory experience. The DARS scale measures desire, motivation, effort, and consummatory pleasure. The DARS is rated on a 5-point Likert scale (0=not at all, 1=slightly, 2=moderately, 3=mostly, 4=very much) and responses are summed to generate the total score (ranges from 0 to 68). A lower total score is indicative of greater anhedonia. Positive changes in DARS total score indicate improvement. | Full analysis set (ANH+) included all adult randomized participants with MDD ANH+ who received at least 1 dose of study intervention. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure. | Posted | Least Squares Mean | Standard Error | Units on a scale | Baseline (Day 1) to Day 43 |
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| Secondary | Change From Baseline Over Time in MADRS Total Score | Change from baseline over time in MADRS total score is reported. The MADRS is a clinician-rated scale designed to measure depression severity and detect changes due to antidepressant treatment. The scale consists of 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of symptoms). MADRS total score is the sum of scores from individual question items, which ranges from 0 to 60; higher scores represent a more severe condition. Negative change in MADRS total score indicates improvement. | Full analysis set (ANH+) included all adult randomized participants with MDD ANH+ who received at least 1 dose of study intervention. Here, 'N' (overall number of participants analyzed) signifies participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants analyzed at specified timepoints. | Posted | Least Squares Mean | Standard Error | Units on a scale | Baseline (Day 1), Days 15, 29 and 43 |
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| Secondary | Percentage of Participants Who Achieved Response on Depressive Symptoms Scale Based on MADRS Total Score at Day 43 | Percentage of participants who achieved response on depressive symptoms scale based on MADRS total score at Day 43 are reported. Responders are defined as participants with a >=50 percent (%) improvement in the MADRS total score from baseline to a given timepoint. The MADRS is a clinician-rated scale designed to measure depression severity and detect changes due to antidepressant treatment. The scale consists of 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of symptoms). MADRS total score is the sum of scores from individual question items, which ranges from 0 to 60; higher scores represent a more severe condition. | Full analysis set (ANH+) included all adult randomized participants with MDD ANH+ who received at least 1 dose of study intervention. | Posted | Number | Percentage of participants | At Day 43 |
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| Secondary | Percentage of Participants With Remission of Depressive Symptoms Based on MADRS Total Score at Day 43 | Percentage of participants with remission of depressive symptoms based on MADRS total score at Day 43 is reported. Participant is defined as a remitter at a given time point if the MADRS total score is less than or equal to (<=)10 at that time point. The MADRS is a clinician-rated scale designed to measure depression severity and detect changes due to antidepressant treatment. The scale consists of 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of symptoms). MADRS total score is the sum of scores from individual question items, which ranges from 0 to 60; higher scores represent a more severe condition. | Full analysis set (ANH+) included all adult randomized participants with MDD ANH+ who received at least 1 dose of study intervention. | Posted | Number | Percentage of participants | At Day 43 |
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| Secondary | Change From Baseline to Day 43 in Patient Health Questionnaire, 9-Item (PHQ-9) Total Score | Change from baseline to Day 43 in PHQ-9 total score is reported. The PHQ-9 is a 9-item, participant reported outcome measure to assess depressive symptoms. The scale scores each of the 9 symptom domains of the Diagnostic and Statistical Manual of Mental Disorders-5th Edition (DSM-5) MDD criteria. Each item is rated on a 4 point scale (0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day). The participant's item responses are summed to provide a total score (range of 0 to 27), with higher scores indicating greater severity of depressive symptoms. The severity of the PHQ-9 is categorized as follows: none-minimal (0-4), mild (5-9), moderate (10-14), moderately severe (15-19) and severe (20-27). Negative changes in PHQ-9 total score indicate improvement. | Full analysis set (ANH+) included all adult randomized participants with MDD ANH+ who received at least 1 dose of study intervention. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure. | Posted | Least Squares Mean | Standard Error | Units on a scale | Baseline (Day 1) to Day 43 |
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| Secondary | Change From Baseline Over Time in DARS Total Score | Change from baseline over time in DARS total score is reported. The DARS is a 17-item self-report questionnaire that is designed to assess anhedonia in MDD across the 4 domains: hobbies, social activities, food/drink, and sensory experience. The DARS scale measures desire, motivation, effort, and consummatory pleasure. The DARS is rated on a 5-point Likert scale (0=not at all, 1=slightly, 2=moderately, 3=mostly, 4=very much) and responses are summed to generate the total score (range of 0 to 68). A lower total score is indicative of greater anhedonia. Positive changes in DARS total score indicate improvement. | Full analysis set (ANH+) included all adult randomized participants with MDD ANH+ who received at least 1 dose of study intervention. Here, 'N' (overall number of participants analyzed) signifies participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants who were analyzed at specified timepoints. | Posted | Least Squares Mean | Standard Error | Units on a scale | Baseline (Day 1), Days 15, 29, and 43 |
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| Secondary | Change From Baseline Over Time in the PHQ-9 Anhedonia-specific Item (PHQ-9, Item 1) | Change from baseline over time in the PHQ-9 anhedonia-specific item (PHQ-9, item 1 is little interest or pleasure in doing things) is reported. The PHQ-9 is a 9-item, participant reported outcome measure to assess depressive symptoms. The scale scores each of the 9 symptom domains of the Diagnostic and Statistical Manual of Mental Disorders-5th Edition (DSM-5) MDD criteria. Each item is rated on a 4 point scale (0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day). The participant's item responses are summed to provide a total score (range of 0 to 27), with higher scores indicating greater severity of depressive symptoms. The severity of the PHQ-9 is categorized as follows: none-minimal (0-4), mild (5-9), moderate (10-14), moderately severe (15-19) and severe (20-27). Negative changes in PHQ-9 total score indicate improvement. | Full analysis set (ANH+) included all adult randomized participants with MDD ANH+ who received at least 1 dose of study intervention. Here, 'N' (overall number of participants analyzed) signifies participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants who were analyzed at specified timepoints. | Posted | Mean | Standard Deviation | Units on a scale | Baseline (Day 1), Day 15, Day 29, and Day 43 |
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| Secondary | Percentage of Participants With a Score Less Than (<) 2 in the PHQ-9 Anhedonia-specific Item (PHQ-9, Item 1) at Day 43 | Percentage of participants with a score <2 in the PHQ-9 anhedonia-specific item (PHQ-9, item 1 is little interest or pleasure in doing things) at Day 43 is reported. The PHQ-9 is a 9-item, participant reported outcome measure to assess depressive symptoms. The scale scores each of the 9 symptom domains of the Diagnostic and Statistical Manual of Mental Disorders-5th Edition (DSM-5) MDD criteria. Each item is rated on a 4 point scale (0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day). The participant's item responses are summed to provide a total score (range of 0 to 27), with higher scores indicating greater severity of depressive symptoms. The severity of the PHQ-9 is categorized as follows: none-minimal (0-4), mild (5-9), moderate (10-14), moderately severe (15-19) and severe (20-27). | Full analysis set (ANH+) included all adult randomized participants with MDD ANH+ who received at least 1 dose of study intervention. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure. | Posted | Number | Percentage of participants | At Day 43 |
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| Secondary | Change From Baseline Over Time in Patient Reported Outcomes Measurement Information System Short Form - Ability to Participate in Social Roles and Activities - 8a (PROMIS-APS 8a) | Change from baseline over time in the PROMIS-APS 8a is reported. This 8-item measure assesses participants' ability to participate in social roles and activities. The items measures the degree of involvement in social roles, activities, and responsibilities, including work, family, friends, and leisure. Each item is rated on a 5-point ordinal scale including 1=always, 2=usually, 3=sometimes, 4=rarely and 5=never, with higher scores indicating better social functioning. The total scores of PROMIS-APS 8a ranges from 8 to 40 and is transformed using a T-score metric with a mean of 50 and a standard deviation of 10. T-score ranges from 25.9 to 65.4, a higher score indicates better social functioning. Positive change in score indicates improvement. | Full analysis set (ANH+) included all adult randomized participants with MDD ANH+ who received at least 1 dose of study intervention. Here, 'N' (overall number of participants analyzed) signifies participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants analyzed at specified timepoints. | Posted | Least Squares Mean | Standard Error | T-score | Baseline (Day 1), Days 15, 29, and 43 |
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| Secondary | Percent Change From Baseline Over Time in Work Productivity and Activity Impairment: Depression (WPAI:D) | The WPAI:D questionnaire is a validated short instrument that assesses impairment in work and other regular activities over the past 7 days. The WPAI yields four types of scores: (a) Absenteeism (work time missed); (b) Presenteeism (impairment at work / reduced on-the-job effectiveness); (c) Work productivity loss (overall work impairment / absenteeism plus presenteeism); (d) Activity Impairment. The first three scores are derived only for respondents who were working (should be missing for non-working), but the last score is applicable for all respondents. Each score ranges from 0 to 100 with higher scores indicating greater impairment and less productivity. Negative changes in score indicates less impairment and greater productivity. | Full analysis set (ANH+) included all adult randomized participants with MDD ANH+ who received at least 1 dose of study intervention. As planned overall work impairment (absenteeism plus presenteeism) and activity impairment is reported. Here, 'N' (overall number of participants analyzed) signifies participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants who were analyzed at specified timepoints. | Posted | Least Squares Mean | Standard Error | Percent Change | Baseline (Day 1), Days 29 and 43 |
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| Secondary | DB Treatment Phase: Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) | Percentage of participants with TEAEs during DB treatment phase are reported. A TEAE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. A TEAE does not necessarily have a causal relationship with the intervention. TEAEs included both serious and non serious adverse events. TEAEs were defined as AEs with onset during the DB Treatment Phase, or AEs that are a consequence of a pre-existing condition that has worsened since baseline (Day 1). | Safety analysis set included all randomized participants (adults and elderly) who received at least 1 dose of study intervention. | Posted | Number | Percentage of participants | From start of treatment (Day 1) up to Day 43 |
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| Secondary | Follow-up (FU) Phase: Percentage of Participants With AEs | An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. | Follow-up analysis set included all randomized participants who entered the follow-up phase after the double-blind treatment phase. | Posted | Number | Percentage of participants | From Day 44 up to Day 57 |
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DB treatment phase: start of treatment (Day 1) up to Day 43, FU Phase: From Day 44 up to Day 57
DB phase: Safety analysis set included all randomized participants (adults and elderly) who received at least 1 dose of study treatment. FU phase population included all randomized participants who entered the FU phase after the double-blind treatment phase.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DB: Placebo | During DB treatment phase, participants received placebo matching to aticaprant tablet orally once daily from Day 1 to Day 42 in addition to the ongoing antidepressant therapy (SSRI/SNRI). | 0 | 258 | 1 | 258 | 34 | 258 |
| EG001 | DB: Aticaprant 10 mg | During the DB treatment phase, participants received aticaprant 10 mg tablet orally once daily from Day 1 to Day 42 in addition to the ongoing antidepressant therapy (SSRI/SNRI). | 0 | 253 | 3 | 253 | 54 | 253 |
| EG002 | FU: Placebo | Participants who received placebo and completed DB phase entered follow-up phase and were then followed up for safety up to 7 to 14 days after end of DB phase at Day 43 (up to Day 57). | 0 | 24 | 0 | 24 | 0 | 24 |
| EG003 | FU: Aticaprant | Participants who received aticaprant 10 mg and completed DB phase entered follow-up phase and were then followed up for safety up to 7 to 14 days after end of DB phase at Day 43 (up to Day 57). | 0 | 14 | 0 | 14 | 1 | 14 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pancreatitis Acute | Gastrointestinal disorders | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Suicidal Behaviour | Psychiatric disorders | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 27.0 | Non-systematic Assessment |
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A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Executive Medical Director | Janssen Research and Development, LLC | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 8, 2024 | Sep 16, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D059445 | Anhedonia |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000590915 | Aticaprant |
Not provided
Not provided
Not provided
| Between 18 and 64 years |
|
| Between 65 to 74 years |
|
| Male |
|
| Undifferentiated |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
|
| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
|
| White |
|
| More than one race |
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| Missing or Not reported |
|
| Australia |
|
| Belgium |
|
| Brazil |
|
| Bulgaria |
|
| Czech Republic |
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| Hungary |
|
| Italy |
|
| Poland |
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| Portugal |
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| Spain |
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| Sweden |
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| United States |
|
During DB treatment phase, participants received aticaprant 10 mg tablet orally once daily from Day 1 to Day 42 in addition to the ongoing antidepressant therapy (SSRI/SNRI). Participants were then followed up for safety up to 7 to 14 days after end of DB phase at Day 43 (up to Day 57). Participants who completed the DB phase (at Day 43) and were compliant to the study intervention were eligible to participate in a separate 52-week open-label long-term safety study 67953964MDD3003 (NCT05518149). |
|
|
| OG001 | Aticaprant 10 mg | During DB treatment phase, participants received aticaprant 10 mg tablet orally once daily from Day 1 to Day 42 in addition to the ongoing antidepressant therapy (SSRI/SNRI). Participants were then followed up for safety up to 7 to 14 days after end of DB phase at Day 43 (up to Day 57). Participants who completed the DB phase (at Day 43) and were compliant to the study intervention were eligible to participate in a separate 52-week open-label long-term safety study 67953964MDD3003 (NCT05518149). |
|
|
| OG001 | Aticaprant 10 mg | During DB treatment phase, participants received aticaprant 10 mg tablet orally once daily from Day 1 to Day 42 in addition to the ongoing antidepressant therapy (SSRI/SNRI). Participants were then followed up for safety up to 7 to 14 days after end of DB phase at Day 43 (up to Day 57). Participants who completed the DB phase (at Day 43) and were compliant to the study intervention were eligible to participate in a separate 52-week open-label long-term safety study 67953964MDD3003 (NCT05518149). |
|
|
| OG001 | Aticaprant 10 mg | During DB treatment phase, participants received aticaprant 10 mg tablet orally once daily from Day 1 to Day 42 in addition to the ongoing antidepressant therapy (SSRI/SNRI). Participants were then followed up for safety up to 7 to 14 days after end of DB phase at Day 43 (up to Day 57). Participants who completed the DB phase (at Day 43) and were compliant to the study intervention were eligible to participate in a separate 52-week open-label long-term safety study 67953964MDD3003 (NCT05518149). |
|
|
| OG001 | Aticaprant 10 mg | During DB treatment phase, participants received aticaprant 10 mg tablet orally once daily from Day 1 to Day 42 in addition to the ongoing antidepressant therapy (SSRI/SNRI). Participants were then followed up for safety up to 7 to 14 days after end of DB phase at Day 43 (up to Day 57). Participants who completed the DB phase (at Day 43) and were compliant to the study intervention were eligible to participate in a separate 52-week open-label long-term safety study 67953964MDD3003 (NCT05518149). |
|
|
|
| OG001 | Aticaprant 10 mg | During DB treatment phase, participants received aticaprant 10 mg tablet orally once daily from Day 1 to Day 42 in addition to the ongoing antidepressant therapy (SSRI/SNRI). Participants were then followed up for safety up to 7 to 14 days after end of DB phase at Day 43 (up to Day 57). Participants who completed the DB phase (at Day 43) and were compliant to the study intervention were eligible to participate in a separate 52-week open-label long-term safety study 67953964MDD3003 (NCT05518149). |
|
|
| OG001 | Aticaprant 10 mg | During DB treatment phase, participants received aticaprant 10 mg tablet orally once daily from Day 1 to Day 42 in addition to the ongoing antidepressant therapy (SSRI/SNRI). Participants were then followed up for safety up to 7 to 14 days after end of DB phase at Day 43 (up to Day 57). Participants who completed the DB phase (at Day 43) and were compliant to the study intervention were eligible to participate in a separate 52-week open-label long-term safety study 67953964MDD3003 (NCT05518149). |
|
|
| OG001 | Aticaprant 10 mg | During DB treatment phase, participants received aticaprant 10 mg tablet orally once daily from Day 1 to Day 42 in addition to the ongoing antidepressant therapy (SSRI/SNRI). Participants were then followed up for safety up to 7 to 14 days after end of DB phase at Day 43 (up to Day 57). Participants who completed the DB phase (at Day 43) and were compliant to the study intervention were eligible to participate in a separate 52-week open-label long-term safety study 67953964MDD3003 (NCT05518149). |
|
|
| OG001 | Aticaprant 10 mg | During DB treatment phase, participants received aticaprant 10 mg tablet orally once daily from Day 1 to Day 42 in addition to the ongoing antidepressant therapy (SSRI/SNRI). Participants were then followed up for safety up to 7 to 14 days after end of DB phase at Day 43 (up to Day 57). Participants who completed the DB phase (at Day 43) and were compliant to the study intervention were eligible to participate in a separate 52-week open-label long-term safety study 67953964MDD3003 (NCT05518149). |
|
|
| OG001 | Aticaprant 10 mg | During DB treatment phase, participants received aticaprant 10 mg tablet orally once daily from Day 1 to Day 42 in addition to the ongoing antidepressant therapy (SSRI/SNRI). Participants were then followed up for safety up to 7 to 14 days after end of DB phase at Day 43 (up to Day 57). Participants who completed the DB phase (at Day 43) and were compliant to the study intervention were eligible to participate in a separate 52-week open-label long-term safety study 67953964MDD3003 (NCT05518149). |
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| Units | Counts |
|---|---|
| Participants |
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