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

Inclusion criteria

• {"criterion_text":"- Completed a previous NMRA-335140 Phase 3 MDD study (NMRA-335140-301, NMRA-335140-302, or NMRA-335140-303) according to the completion definition in the parent study protocol.\n- Signed an informed consent form (ICF) for this study. Note: For participants in the Czech Republic, every participant must have a caregiver participate in the study to help monitor compliance and safety during the study. The caregiver must be in personal contact with the participant at least 5 days a week in severely depressed participants or 2 days a week in moderately depressed participants and accompany the participant to study visits. The caregiver must sign a separate caregiver ICF.\n- Willing to comply with the contraception requirements described in the inclusion criteria of the parent study protocol.\n- Willing to comply with the concomitant medication/therapy restrictions described in the exclusion criteria of the parent study protocol."}

Exclusion criteria

• {"criterion_text":"- Diagnosed with another Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) disorder that would have been exclusionary in the parent study (eg, personality disorder, bipolar 1 or 2, schizophrenia, any other psychotic disorder, or moderate or severe substance or alcohol use disorder [excluding nicotine]).\n- Considered to be at significant risk of suicide in the judgment of the Investigator. This includes participants who are actively suicidal (eg, any suicide attempts during the parent study) or are at serious suicidal risk as indicated by any current suicidal intent, including a plan, as assessed by the C-SSRS (\"Since Last Visit\" version, score of \"YES\" on suicidal ideation Item 4 or 5) and/or based on clinical evaluation by the Investigator; or are homicidal, in the opinion of the Investigator.\n- Non-adherent with study medication (took less than or equal to 70% of study drug over any 2-week visit interval) or procedures during the parent study.\n- Experienced treatment emergent adverse events (TEAEs) considered related to the study medication from the parent study and judged by the Investigator to be clinically significant to render the participant ineligible for enrollment.\n- Have an abnormality on ocular examination that would prohibit continued study participation as determined by the Investigator.\n- Use of disallowed concomitant medication or therapy that would have been exclusionary in the parent study, may compromise the safety of the participant, and/or confound the interpretation of protocol assessments.\n- Considered by the Investigator to be inappropriate for any other reason."}

Primary endpoints

• {"endpoint_text":"- Safety and tolerability assessments based on adverse events (AEs), clinical laboratory parameters, electrocardiograms (ECGs), vital signs, physical examinations, ophthalmologic examination and corneal specular microscopy (CSM), Columbia Suicide Severity Rating Scale (C-SSRS), and Change in Sexual Functioning Questionnaire-14 (CSFQ-14).","definition_or_measurement_approach":"Safety and tolerability assessed by collection and evaluation of AEs, clinical laboratory parameters, ECGs, vital signs, physical examinations, ophthalmologic exams including corneal specular microscopy (CSM), C-SSRS for suicidality, and CSFQ-14 for sexual functioning."}

Secondary endpoints

• {"endpoint_text":"- Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score over time.\n- Change from baseline in the Snaith-Hamilton Pleasure Scale (SHAPS) total score over time.\n- Change from baseline in the Patient Health Questionnaire-9 (PHQ-9) total score over time.\n- Change from baseline in PHQ-9 Anhedonia Item #1 over time.\n- Change from baseline in the Hamilton Anxiety Rating Scale (HAM-A) total score over time.\n- Change from baseline in the Clinical Global Impression of Severity (CGI-S) score over time\n- Value at each timepoint assessed in the Clinical Global Impression of Improvement (CGI-I) score.\n- Percentage of participants whose MADRS total score decreased by greater than or equal to 50% from baseline over time.\n- Percentage of participants whose MADRS total score decreased to 10 or less over time.\n- Change from baseline in the Sheehan Disability Scale (SDS) over time.","definition_or_measurement_approach":"All secondary endpoints are changes or values over time measured using the specified validated rating scales (MADRS, SHAPS, PHQ-9 including Anhedonia item, HAM-A, CGI-S, CGI-I) and SDS; responder and remission thresholds (e.g., ≥50% MADRS decrease; MADRS ≤10) measured over scheduled visits."}

Germany

Earliest CTIS Part Ii Submission Date

04-06-2024

Latest Decision Or Authorization Date

26-06-2024

Processing Time Days

22

Number Of Sites

4

Number Of Participants

139

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

42

Finland

Earliest CTIS Part Ii Submission Date

05-06-2024

Latest Decision Or Authorization Date

27-06-2024

Processing Time Days

22

Number Of Sites

3

Number Of Participants

22

Czechia

Earliest CTIS Part Ii Submission Date

26-06-2024

Latest Decision Or Authorization Date

08-07-2024

Processing Time Days

12

Number Of Sites

3

Number Of Participants

97

Sweden

Earliest CTIS Part Ii Submission Date

05-06-2024

Latest Decision Or Authorization Date

25-06-2024

Processing Time Days

20

Number Of Sites

2

Number Of Participants

24

Poland

Earliest CTIS Part Ii Submission Date

07-06-2024

Latest Decision Or Authorization Date

05-07-2024

Processing Time Days

28

Number Of Sites

6

Number Of Participants

77

Bulgaria

Earliest CTIS Part Ii Submission Date

10-06-2024

Latest Decision Or Authorization Date

01-07-2024

Processing Time Days

21

Number Of Sites

7

Number Of Participants

94

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

codes: 1,11,12,13,2,3,4,5,6,8

Name

Tigermed-Bdm Inc.

Responsibilities

code: 10

Name

Almac Clinical Services LLC

Responsibilities

code: 14

Name

WCG Clinical Inc.

Responsibilities

codes: 13, 15 (eCOA, Rater Training)

Third parties

• {"country":"United States","full_name":"Psomagen Inc.","duties_or_roles":"code: 4","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Patient concierge","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"United States","full_name":"Tigermed-Bdm Inc.","duties_or_roles":"code: 10","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Almac Clinical Services LLC","duties_or_roles":"code: 14","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Alturas Analytics Inc.","duties_or_roles":"code: 4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"code: 7","organisation_type":"Non-Pharmaceutical company"}
• {"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":"codes: 13, 15 (Ophthalmology)","organisation_type":"Health care"}
• {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"codes: 1,11,12,13,2,3,4,5,6,8","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"codes: 13, 15 (eCOA, Rater Training)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Mms Holdings Inc.","duties_or_roles":"code: 15 (Pharmacovigilance)","organisation_type":"Pharmaceutical company"}