RECRUITING

Study to Assess the Safety and Effectiveness of NMRA-335140-501

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Conditions

Major Depressive DisorderNMRA-335140Long-termSafetyEfficacyNavacaprantNMRA335140NMRA 335140

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a 52-week open-label extension (OLE) study that will evaluate the safety, tolerability, and effectiveness of NMRA-335140 in participants with major depressive disorder (MDD). Participants who completed a parent study investigating the efficacy and safety of NMRA-335140 as a treatment for MDD (ie, NMRA-335140-301, NMRA-335140-302, or NMRA-335140-303), and complete the 6 weeks double-blind treatment, provide informed consent, and meet eligibility criteria, may enter this extension study.

Official Title

Long-term Study to Assess the Safety and Effectiveness of NMRA-335140 in Participants With Major Depressive Disorder

Quick Facts

Study Start:2023-11-10
Study Completion:2027-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06029439

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Completed a previous NMRA-335140 Phase 3 MDD study (example: NMRA-335140-301, NMRA-335140-302, or NMRA-335140-303) according to the completion definition in the parent study protocol.
  2. * Signed an informed consent form (ICF) for this study.
  3. * Willing to comply with the contraception requirements described in the inclusion criteria of the parent study protocol.
  4. * Willing to comply with the concomitant medication/therapy restrictions described in the exclusion criteria of the parent study protocol.
  1. * 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 \[excluding nicotine\]).
  2. * 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.
  3. * Non-adherent with study medication (took ≤70% of study drug over any 2-week visit interval) or procedures during the parent study.
  4. * 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.
  5. * Have an abnormality on ocular examination that would prohibit continued study participation as determined by the Investigator.
  6. * 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.
  7. * Considered by the Investigator to be inappropriate for any other reason.

Contacts and Locations

Study Contact

Study Contact
CONTACT
explore@koastalstudy.com

Study Locations (Sites)

Neumora Investigator site
Huntsville, Alabama, 35801
United States
Neumora Investigator Site
Phoenix, Arizona, 85012
United States
Neumora Investigator Site
Bentonville, Arkansas, 72712
United States
Neumora Investigator site
Little Rock, Arkansas, 72211
United States
Neumora Investigator Site
Rogers, Arkansas, 72758
United States
Neumora Investigator site
Bellflower, California, 90706
United States
Neumora Investigator Site
Cerritos, California, 90703
United States
Neumora Investigator Site
Garden Grove, California, 92845
United States
Neumora Investigator Site
Glendale, California, 91206
United States
Neumora Investigator Site
Imperial, California, 92251
United States
Neumora Investigator Site
Irvine, California, 92614
United States
Neumora Investigator Site
Lafayette, California, 94549
United States
Neumora Investigator Site-1
Long Beach, California, 90807
United States
Neumora Investigator site
Long Beach, California, 90807
United States
Neumora Investigator Site
Los Angeles, California, 90015
United States
Neumora Investigator Site
Oceanside, California, 92056
United States
Neumora Investigator Site-1
Orange, California, 92868
United States
Neumora Investigator Site
Orange, California, 92868
United States
Neumora Investigator Site
Riverside, California, 92506
United States
Neumora Investigator Site
San Jose, California, 95124
United States
Neumora Investigator Site
Santa Ana, California, 92704
United States
Neumora Investigator Site
Sherman Oaks, California, 91403
United States
Neumora Investigator Site
Temecula, California, 92591
United States
Neumora Investigator Site
Torrance, California, 90504
United States
Neumora Investigator Site
Colorado Springs, Colorado, 80910
United States
Neumora Investigator Site
Norwalk, Connecticut, 06851
United States
Neumora Investigator Site
Bradenton, Florida, 34205
United States
Neumora Investigator Site
Brandon, Florida, 33511
United States
Neumora Investigator Site
Gainesville, Florida, 32607
United States
Neumora Investigator Site
Hallandale Beach, Florida, 33009
United States
Neumora Investigator Site
Hialeah, Florida, 33012
United States
Neumora Investigator Site
Hialeah, Florida, 33016
United States
Neumora Investigator Site
Jacksonville, Florida, 32256
United States
Neumora Investigator Site
Lauderhill, Florida, 33319
United States
Neumora Investigator Site #1
Maitland, Florida, 32751
United States
Neumora Investigator Site
Maitland, Florida, 32751
United States
Neumora Investigator Site
Miami Beach, Florida, 33140
United States
Neumora Investigator site
Miami Lakes, Florida, 33014
United States
Neumora Investigator Site-1
Miami Lakes, Florida, 33016
United States
Neumora Investigator Site
Miami Lakes, Florida, 33016
United States
Neumora Investigator Site
Miami Springs, Florida, 33166
United States
Neumora Investigator Site
Miami, Florida, 33122
United States
Neumora Investigator Site
Miami, Florida, 33126
United States
Neumora Investigator Site
Miami, Florida, 33133
United States
Neumora Investigator Site
Miami, Florida, 33137
United States
Neumora Investigator Site
Miami, Florida, 33143
United States
Neumora Investigator Site
Miami, Florida, 33165
United States
Neumora Investigator Site
Miami, Florida, 33174
United States
Neumora Investigator site
Miami, Florida, 33183
United States
Neumora Investigator Site-1
Orlando, Florida, 32801
United States
Neumora Investigator site
Orlando, Florida, 32801
United States
Neumora Investigator Site
Orlando, Florida, 32807
United States
Neumora Investigator Site
Pembroke Pines, Florida, 33024
United States
Neumora Investigator Site #1
Pompano Beach, Florida, 33060
United States
Neumora Investigator Site
Pompano Beach, Florida, 33060
United States
Neumora Investigator Site
Tampa, Florida, 33607
United States
Neumora Investigator Site-1
Atlanta, Georgia, 30328
United States
Neumora Investigator Site
Atlanta, Georgia, 30328
United States
Neumora Investigator Site
Atlanta, Georgia, 30338
United States
Neumora Investigator Site
Decatur, Georgia, 30030
United States
Neumora Investigator Site
Marietta, Georgia, 30060
United States
Neumora Investigator Site
Savannah, Georgia, 31405
United States
Neumora Investigator Site
Chicago, Illinois, 60634
United States
Neumora Investigator Site
Warrenville, Illinois, 60555
United States
Neumora Investigator Site
Marrero, Louisiana, 70072
United States
Neumora Investigator Site
New Orleans, Louisiana, 70115
United States
Neumora Investigator Site
Baltimore, Maryland, 21208
United States
Neumora Investigator site
Towson, Maryland, 21204
United States
Neumora Investigator Site
Boston, Massachusetts, 02116
United States
Neumora Investigator Site
Boston, Massachusetts, 02131
United States
Neumora Investigator site
Methuen, Massachusetts, 01844
United States
Neumora Investigator site
Springfield, Massachusetts, 01103
United States
Neumora Investigator Site
Watertown, Massachusetts, 02472
United States
Neumora Investigator site
Bloomfield Township, Michigan, 48302
United States
Neumora Investigator Site
Flowood, Mississippi, 39232
United States
Neumora Investigator Site
Saint Charles, Missouri, 63304
United States
Neumora Investigator Site
Saint Louis, Missouri, 63141
United States
Neumora Investigator Site
Las Vegas, Nevada, 89102
United States
Neumora Investigator Site
Berlin, New Jersey, 08009
United States
Neumora Investigator site
Princeton, New Jersey, 08540
United States
Neumora Investigator Site
Toms River, New Jersey, 08755
United States
Neumora Investigator Site
Bronx, New York, 10461
United States
Neumora Investigator Site
Brooklyn, New York, 11224
United States
Neumora Investigator Site
Cedarhurst, New York, 11516
United States
Neumora Investigator Site
New York, New York, 10017
United States
Neumora Investigator Site
New York, New York, 10029
United States
Neumora Investigator Site
New York, New York, 10036
United States
Neumora Investigator Site
Staten Island, New York, 10310
United States
Neumora Investigator Site
Staten Island, New York, 10314
United States
Neumora Investigator Site
Charlotte, North Carolina, 28211
United States
Neumora Investigator Site
Monroe, North Carolina, 28112
United States
Neumora Investigator Site
Columbus, Ohio, 43210
United States
Neumora Investigator Site
Dayton, Ohio, 45417
United States
Neumora Investigator Site
North Canton, Ohio, 44720
United States
Neumora Investigator Site
Edmond, Oklahoma, 73013
United States
Neumora Investigator Site
Oklahoma City, Oklahoma, 73118
United States
Neumora Investigator Site
Allentown, Pennsylvania, 18104
United States
Neumora Investigator Site
Media, Pennsylvania, 19063
United States
Neumora Investigator Site
Memphis, Tennessee, 38119
United States
Neumora Investigator Site
Austin, Texas, 78737
United States
Neumora Investigator site
Austin, Texas, 78759
United States
Neumora Investigator Site
Fort Worth, Texas, 76104
United States
Neumora Investigator Site
Houston, Texas, 77030
United States
Neumora Investigator Site
Houston, Texas, 77090
United States
Neumora Investigator Site
Wichita Falls, Texas, 76309
United States
Neumora Investigator Site
Bellevue, Washington, 98007
United States
Neumora Investigator Site
Everett, Washington, 98201
United States

Collaborators and Investigators

Sponsor: Neumora Therapeutics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-10
Study Completion Date2027-06

Study Record Updates

Study Start Date2023-11-10
Study Completion Date2027-06

Terms related to this study

Keywords Provided by Researchers

  • Major Depressive Disorder
  • NMRA-335140
  • Long-term
  • Safety
  • Efficacy
  • Navacaprant
  • NMRA335140
  • NMRA 335140

Additional Relevant MeSH Terms

  • Major Depressive Disorder