Clinical trial • Phase III • Psychiatry
1-[6-ETHYL-8-FLUORO-4-METHYL-3-(3-METHYL-1,2,4-OXADIAZOL-5-YL)QUINOLIN-2-YL]-N-(OXAN-4-YL)PIPERIDIN-4-AMINE for Major Depressive Disorder
Phase III trial of 1-[6-ETHYL-8-FLUORO-4-METHYL-3-(3-METHYL-1,2,4-OXADIAZOL-5-YL)QUINOLIN-2-YL]-N-(OXAN-4-YL)PIPERIDIN-4-AMINE for Major Depressive Disord…
Overview
- Trial Therapeutic Area
- Psychiatry
- Trial Disease
- Major Depressive Disorder
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 15-03-2024
- First CTIS Authorization Date
- 20-06-2024
Trial design
Randomised, nmra-335140 arm: participants will receive 80mg nmra-335140 qd; placebo arm: participants will receive identical placebo nmra-335140 qd (placebo identical to active to maintain blinding).-controlled Phase III trial in Finland, France, Sweden and others.
- Randomised
- Yes
- Comparator
- NMRA-335140 Arm: Participants will receive 80mg NMRA-335140 QD; Placebo Arm: Participants will receive identical placebo NMRA-335140 QD (placebo identical to active to maintain blinding).
- Target Sample Size
- 205
- Trial Duration For Participant
- 42
Eligibility
Recruits 205 The trial record indicates vulnerable populations are selected (populationOfTrialSubjects.isVulnerablePopulationSelected = true). Subject information and consent form documents include caregiver and minor/pregnant-partner versions (e.g., document titles such as 'L1_CZ_SIS-ICF_Caregiver_Czech_redacted', 'L1_DE_SIS-ICF_Minor Pregnant Partner_German', 'L1_DE_SIS-ICF_Adult Pregnant Partner_German'), indicating procedures for obtaining consent/assent and caregiver involvement where applicable. Adult participants provide informed consent; caregiver-consent/assent materials are available as indicated by the document titles..
- Vulnerable Population
- The trial record indicates vulnerable populations are selected (populationOfTrialSubjects.isVulnerablePopulationSelected = true). Subject information and consent form documents include caregiver and minor/pregnant-partner versions (e.g., document titles such as 'L1_CZ_SIS-ICF_Caregiver_Czech_redacted', 'L1_DE_SIS-ICF_Minor Pregnant Partner_German', 'L1_DE_SIS-ICF_Adult Pregnant Partner_German'), indicating procedures for obtaining consent/assent and caregiver involvement where applicable. Adult participants provide informed consent; caregiver-consent/assent materials are available as indicated by the document titles.
Inclusion criteria
- {"criterion_text":"- 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)."}
- {"criterion_text":"- Participant's current major depressive episode must be confirmed by independent assessment."}
- {"criterion_text":"- 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."}
- {"criterion_text":"- Have a MADRS total score of 25 or higher at Screening and Baseline."}
- {"criterion_text":"- A change in MADRS total score between Screening and Baseline of ≤20%."}
Exclusion criteria
- {"criterion_text":"- Have failed 2 or more courses of antidepressant treatment at sufficient doses for at least 6 to 8 weeks for the current MDD episode."}
- {"criterion_text":"- Currently or in the past year have been diagnosed with a personality disorder per the 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."}
- {"criterion_text":"- Have a lifetime diagnosis of bipolar 1 or 2, schizophrenia or schizoaffective, schizophreniform, obsessive compulsive disorder, or post-traumatic stress disorder (PTSD)."}
- {"criterion_text":"- Have moderate to severe substance or alcohol use disorder, per DSM-5-TR criteria, within the 12 months prior to screening (excluding nicotine)."}
- {"criterion_text":"- Are actively suicidal (eg, any suicide attempts within the past 12 months) or are 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) (score of \"YES\" on suicidal ideations Item 4 or 5 within 3 months prior to Visit 1 [Screening]) and/or based on clinical evaluation by the Investigator; or are homicidal, in the opinion of the Investigator. 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."}
Endpoints
Primary endpoints
- {"endpoint_text":"- The primary endpoint is the treatment difference in change from Baseline to Week 6 in the MADRS total score.","definition_or_measurement_approach":"Change from Baseline to Week 6 in the MADRS (Montgomery-Åsberg Depression Rating Scale) total score."}
Secondary endpoints
- {"endpoint_text":"- Participant reported symptoms of anhedonia. Change from Baseline to Week 6 assessed in the Snaith-Hamilton Pleasure Scale (SHAPS) total score. Change from Baseline to each timepoint assessed in the SHAPS total score","definition_or_measurement_approach":"Change from Baseline to Week 6 and to each timepoint in SHAPS total score (Snaith-Hamilton Pleasure Scale)."}
- {"endpoint_text":"- MADRS response rate. Percentage of participants whose MADRS total score decreased by greater than or equal to 50% from Baseline.","definition_or_measurement_approach":"Percentage of participants with ≥50% reduction in MADRS total score from Baseline."}
- {"endpoint_text":"- MADRS scores over time. Change from Baseline to each timepoint assessed in MADRS total scores.","definition_or_measurement_approach":"Change from Baseline to each scheduled timepoint in MADRS total score."}
- {"endpoint_text":"- Clinical assessment of MDD severity and improvement. Change from Baseline to each timepoint assessed in Clinical Global Impression of Severity (CGIS) score. Value at each timepoint assessed in Clinical Global Impression of Improvement (CGI-I) score","definition_or_measurement_approach":"Change from Baseline in CGI-S at each timepoint; CGI-I value at each timepoint."}
- {"endpoint_text":"- Participant reported symptoms of MDD. Change from Baseline to each timepoint assessed in Patient Health Questionnaire9 (PHQ9) total score","definition_or_measurement_approach":"Change from Baseline to each timepoint in PHQ-9 total score."}
- {"endpoint_text":"- Participant reported severity of anhedonia. Change from Baseline to each timepoint assessed in PHQ9 Anhedonia Item #1","definition_or_measurement_approach":"Change from Baseline to each timepoint in PHQ-9 item #1 (anhedonia)."}
- {"endpoint_text":"- Clinician reported symptoms of anxiety. Change from Baseline to each timepoint assessed in the Hamilton Anxiety Rating Scale (HAMA) total score","definition_or_measurement_approach":"Change from Baseline to each timepoint in HAM-A total score."}
- {"endpoint_text":"- Participant reported assessment of functional impairment. Change from Baseline at Week 6 assessed in the Sheehan Disability Scale (SDS) total score","definition_or_measurement_approach":"Change from Baseline to Week 6 in SDS total score."}
- {"endpoint_text":"- MADRS remission rate. Percentage of participants whose MADRS total score decreased to 10 or less","definition_or_measurement_approach":"Percentage of participants with MADRS total score ≤10 at assessment (remission rate)."}
Recruitment
- Registry Or Advocacy Recruitment
- True, Autocruitment LLC (Patient organisation/association) and Ctsdatabase LLC (Clinical trial subject registry) are named third parties with recruitment/registry roles.
- Digital Remote Recruitment
- True, digital/remote methods explicitly referenced include website materials, digital advertising, Instagram ads, landing pages, and digital prescreening tools (documents: e.g., 'K2_*_Digital Materials_Bilingual', 'K2_*_Instagram Ads', 'K2_*_landingpage').
- Planned Sample Size
- 205
- Recruitment Window Months
- 10
- Consent Approach
- Informed consent is obtained using subject information and informed consent form documents. ICF and subject information documents are available in multiple country-specific languages as indicated by document titles (examples: Czech, German, Polish, Bulgarian, French, Swedish). There are specific caregiver and minor/pregnant-partner consent/assent documents (e.g., 'L1_CZ_SIS-ICF_Caregiver', 'L1_DE_SIS-ICF_Minor Pregnant Partner', 'L1_DE_SIS-ICF_Adult Pregnant Partner'), indicating age- or role-specific consent procedures and caregiver consent handling where applicable.
Methods
- Website recruitment materials (country-specific website PDFs listed for Czech, Germany, Poland, Bulgaria).
- Digital materials and Instagram ads (documents: 'K2_*_Digital Materials_Bilingual', 'K2_*_Instagram Ads').
- Printed materials: Posters, Flyers, Brochures (documents: 'K2_*_Poster', 'K2_*_PDF Flyer', 'K2_*_Brochure').
- Newspaper advertisements (documents: 'K2_*_Newspaper Ad' e.g., Czech/Polish/Bulgarian/German versions).
- Display Ads / Web banners / Landing page (documents: 'K2_*_Display Ads', 'landingpage_Pratia sites_German').
- Telephone recruitment scripts and prescreening tools (documents: 'Telephone Script_Bilingual', 'prescreening_tool_questions').
- Scout / patient concierge and email outreach materials (documents: 'Scout Email', 'Scout Study Brochure').
- Country-specific printed and digital recruitment campaigns (document titles include country codes CZ/DE/PL/BG and are tailored per country site lists).
Geography
- Total Number Of Sites
- 34
- Total Number Of Participants
- 127
Finland
- Earliest CTIS Part Ii Submission Date
- 05-06-2024
- Latest Decision Or Authorization Date
- 24-06-2024
- Processing Time Days
- 19
- Number Of Sites
- 3
- Number Of Participants
- 9
Sites
- Site Name
- Clinical Research Services Turku CRST Oy
- Contact Person Name
- Noora Scheinin
- Contact Person Email
- nmsche@utu.fi
- Site Name
- Lahdelma Consulting Oy
- Contact Person Name
- Liisa Lahdelma
- Contact Person Email
- liisa.lahdelma@kolumbus.fi
- Site Name
- Oulu Mentalcare Oy
- Contact Person Name
- Markku Timonen
- Contact Person Email
- markku.timonen@mentalcare.fi
France
- Earliest CTIS Part Ii Submission Date
- 11-06-2024
- Latest Decision Or Authorization Date
- 28-06-2024
- Processing Time Days
- 17
- Number Of Sites
- 7
- Number Of Participants
- 18
Sites
- Site Name
- University Hospital Of Clermont-Ferrand
- Department Name
- Département de Psychiatrie
- Contact Person Name
- Ludovic Samalin
- Contact Person Email
- lsamalin@chu-clermontferrand.fr
- Site Name
- Desbonnet Recherche
- Contact Person Name
- Philippe Desbonnet
- Contact Person Email
- philippe.desbonnet654@orange.fr
- Site Name
- Centre Hospitalier Henri Laborit
- Department Name
- Department of Psychiatry and Medical Psychology
- Contact Person Name
- Nematollah Jaafari
- Contact Person Email
- Nemat.jaafari@ch-poitiers.fr
- Site Name
- Centre Hospitalier Universitaire De Montpellier
- Department Name
- Service Universitaire de Psychiatrie Adulte
- Contact Person Name
- Jérôme Attal
- Contact Person Email
- j-attal@chu-montpellier.fr
- Site Name
- Centre Hospitalier Georges Mazurelle- EPSM Mazurelle
- Department Name
- Département de Psychiatrie
- Contact Person Name
- Anne Sauvaget
- Contact Person Email
- Anne.sauvaget@chu-nantes.fr
- Site Name
- Centre Hospitalier Universitaire De Nimes
- Department Name
- Pôle Psychiatrie
- Contact Person Name
- Fabrice Boulet
- Contact Person Email
- fabrice.boulet@chu-nimes.fr
- Site Name
- Centre Hospitalier Universitaire D'Angers
- Department Name
- Département de Psychiatrie
- Contact Person Name
- Bénédicte Gohier
- Contact Person Email
- begohier@chu-angers.fr
Sweden
- Earliest CTIS Part Ii Submission Date
- 05-06-2024
- Latest Decision Or Authorization Date
- 20-06-2024
- Processing Time Days
- 15
- Number Of Sites
- 2
- Number Of Participants
- 6
Sites
- Site Name
- ProbarE i Stockholm AB (Lund location)
- Department Name
- ProbareE location in Lund
- Contact Person Name
- Anders Luts
- Contact Person Email
- anders.luts@probare.se
- Site Name
- ProbarE i Stockholm AB (Stockholm location)
- Contact Person Name
- Peter Bosson
- Contact Person Email
- peter.bosson@probare.se
Czechia
- Earliest CTIS Part Ii Submission Date
- 25-06-2024
- Latest Decision Or Authorization Date
- 08-07-2024
- Processing Time Days
- 13
- Number Of Sites
- 3
- Number Of Participants
- 22
Sites
- Site Name
- INEP medical s.r.o.
- Contact Person Name
- Alexander Nawka
- Contact Person Email
- nawka@inep.cz
- Site Name
- Brain-Soultherapy s.r.o.
- Contact Person Name
- Claudia Vodičková-Borzová
- Contact Person Email
- cborzova@seznam.cz
- Site Name
- A-Shine s.r.o.
- Department Name
- Psychiatrie
- Contact Person Name
- Luboš Janů
- Contact Person Email
- lubos.janu@seznam.cz
Germany
- Earliest CTIS Part Ii Submission Date
- 11-06-2024
- Latest Decision Or Authorization Date
- 28-06-2024
- Processing Time Days
- 17
- Number Of Sites
- 5
- Number Of Participants
- 11
Sites
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Department of Psychiatry and Neurosciences
- Contact Person Name
- Dimitris Repantis
- Contact Person Email
- dimitris.repantis@charite.de
- Site Name
- Nervenärztliche Praxis Frau Dr. Kirsten HahN
- Department Name
- Arztpraxis für Neurologie und Psychatrie
- Contact Person Name
- Kirsten Hahn
- Contact Person Email
- hahnkirsten@gmail.com
- Site Name
- Klinische Forschung Hamburg GmbH
- Department Name
- Neurologie und Psychiatrie
- Contact Person Name
- Christian Deckert
- Contact Person Email
- christian.deckert@pratia.com
- Site Name
- Klinische Forschung Berlin-Mitte GmbH
- Department Name
- -
- Contact Person Name
- Sameer Kulkarni
- Contact Person Email
- sameer.kulkarni@pratia.com
- Site Name
- Emovis GmbH
- Department Name
- Dedicated Study Site
- Contact Person Name
- Sascha Öhm
- Contact Person Email
- sascha.oehm@emovis.de
Poland
- Earliest CTIS Part Ii Submission Date
- 25-06-2024
- Latest Decision Or Authorization Date
- 05-07-2024
- Processing Time Days
- 10
- Number Of Sites
- 6
- Number Of Participants
- 27
Sites
- Site Name
- Promente Sp. z o.o.
- Contact Person Name
- Katarzyna Łachut
- Contact Person Email
- rejestracja@pro-mente.pl
- Site Name
- E4r&D Sp. z o.o.
- Contact Person Name
- Wiesław J. Cubała
- Contact Person Email
- cubala@gumed.edu.pl
- Site Name
- Indywidualna Specjalistyczna Praktyka Lekarska Agnieszka Remlinger-Molenda
- Contact Person Name
- Agnieszka Remlinger-Molenda
- Contact Person Email
- aremlinger@gmail.com
- Site Name
- Ginemedica Sp. z o.o.
- Contact Person Name
- Ewa Tylko
- Contact Person Email
- e.tylko@ginemedica.pl
- Site Name
- Prywatne Gabinety Lekarskie 'Promedicus' Anna Agnieszka Tomczak
- Contact Person Name
- Anna Agnieszka Tomczak
- Contact Person Email
- promedicus@onet.eu
- Site Name
- Centrum Medyczne Luxmed Sp. z o.o.
- Contact Person Name
- Dariusz Malicki
- Contact Person Email
- dariuszmalicki@interia.eu
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 31-05-2024
- Latest Decision Or Authorization Date
- 01-07-2024
- Processing Time Days
- 31
- Number Of Sites
- 8
- Number Of Participants
- 34
Sites
- Site Name
- Diagnostic And Consultation Centre St.Vrach And St.St. Kuzma And Damian OOD
- Department Name
- Not applicable
- Contact Person Name
- Petya Dimitrova
- Contact Person Email
- drdimitrova@abv.bg
- Site Name
- Multiprofile Hospital For Active Treatment - Targovishte AD
- Department Name
- Department of Psychiatry
- Contact Person Name
- Ivan Tyanev
- Contact Person Email
- dr.ivan.tyanev@gmail.com
- Site Name
- Diagnostics-Consultancy Center Mladost M Varna OOD
- Department Name
- Not applicable
- Contact Person Name
- Hristo Kozhuharov
- Contact Person Email
- christokojuharov@abv.bg
- Site Name
- Medical Center Lifemed EOOD
- Department Name
- Not applicable
- Contact Person Name
- Rozaliya Rangelova
- Contact Person Email
- rrangelova80@gmail.com
- Site Name
- Dr. Ivo Natsov Outpatient Clinic For Individual Practice For Specialized Medical Care In Psychiatry ET
- Department Name
- Not applicable
- Contact Person Name
- Ivo Natsov
- Contact Person Email
- ivo_nacov@abv.bg
- Site Name
- Medical Center Intermedica Ltd.
- Department Name
- Not applicable
- Contact Person Name
- Toni Donchev
- Contact Person Email
- tonyd@abv.bg
- Site Name
- Medical Center Akademica EOOD
- Department Name
- Not applicable
- Contact Person Name
- Vihra Milanova
- Contact Person Email
- vihra.milanova@gmail.com
- Site Name
- Medical Center (additional listed site)
- Department Name
- Not applicable
- Contact Person Name
- Toni Donchev
- Contact Person Email
- tonyd@abv.bg
Sponsor
Primary sponsor
- Full Name
- Neumora Therapeutics Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Icon Clinical Research Limited
- Responsibilities
- Multiple sponsor duties listed (codes: 1,11,12,13,2,3,4,5,6,8) indicating broad CRO responsibilities as recorded in CTIS thirdParties.sponsorDuties
- Name
- Tigermed-Bdm Inc.
- Responsibilities
- Sponsor duties code: 10 (listed in CTIS thirdParties.sponsorDuties)
- Name
- WCG Clinical Inc.
- Responsibilities
- eCOA, Rater Training (sponsor duties codes: 13, 15 listed)
- Name
- Almac Clinical Services Limited
- Responsibilities
- Sponsor duties code: 14 (listed in CTIS thirdParties.sponsorDuties)
Third parties
- {"country":"United States","full_name":"Mms Holdings Inc.","duties_or_roles":"Pharmacovigilance","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Sponsor duties codes: 1,11,12,13,2,3,4,5,6,8 (as listed in CTIS thirdParties.sponsorDuties)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Psomagen Inc.","duties_or_roles":"Sponsor duties codes: 13,4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Massachusetts General Hospital","duties_or_roles":"Independent depression study eligibility assessment","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"United States","full_name":"Tigermed-Bdm Inc.","duties_or_roles":"Sponsor duties codes: 10","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Alturas Analytics Inc.","duties_or_roles":"Sponsor duties codes: 13,4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"Sponsor duties codes: 7","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"Sponsor duties codes: 13 and 15 (Cardiac safety)","organisation_type":"Pharmaceutical company"}
- {"country":"France","full_name":"Hydrogen","duties_or_roles":"recruitment","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"Sponsor duties codes: 13 and 15 (eCOA, Rater Training)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Aicure LLC","duties_or_roles":"IP compliance","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Autocruitment LLC","duties_or_roles":"Participant recruitment","organisation_type":"Patient organisation/association"}
- {"country":"United States","full_name":"Ctsdatabase LLC","duties_or_roles":"Clinical trial subject registry","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Clinical Services Limited","duties_or_roles":"Sponsor duties codes: 14","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Patient concierge","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"France","full_name":"Quipment","duties_or_roles":"Equipment - Konan Microscope","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Voiant","duties_or_roles":"Ophthalmology","organisation_type":"Health care"}
Investigational products
- Investigational Product Name
- NMRA-335140
- Active Substance
- 1-[6-ETHYL-8-FLUORO-4-METHYL-3-(3-METHYL-1,2,4-OXADIAZOL-5-YL)QUINOLIN-2-YL]-N-(OXAN-4-YL)PIPERIDIN-4-AMINE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- Oral
- Authorisation Status
- Investigational (marketingAuthNumber: N/A; prodAuthStatus: 1 as recorded)
- Starting Dose
- 80 mg
- Dose Levels
- 80 mg
- Frequency
- QD
- Maximum Dose
- 80 mg
- Investigational Product Name
- Placebo is identical to the active NMRA-335140 but without the active drug substance to maintain study blinding.
- Modality
- Other
- Routes Of Administration
- ORAL
- Route
- Oral
- Frequency
- QD
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