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NMRA-335140 · 6 trials · 2 indications
The MADRS is a 10-item, clinician-rated scale that evaluates the participant's depressive symptomatology during the past week. Participants are rated on items assessing feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each item will be scored on a 7- point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity. Thus, scores in the MADRS range from 0 to 60, with increasing scores indicating increasing severity.
An AE is any untoward medical occurrence in a participant or clinical trial participant, temporally associated with the use of trial intervention, whether or not considered related to the trial intervention. Any AE occurring following the start of treatment or occurring before treatment but increasing in severity afterward were counted as treatment-emergent AE (TEAE). Clinically significant abnormalities in Clinical Laboratory Evaluations, ECGs, Vital Signs, Physical and Ophthalmological examinations, Corneal Specular Microscopy, Columbia Suicide Severity Rating Scale (C-SSRS), and Sexual Functioning Questionnaire-14 (CSFQ-14) will be reported as TEAEs.
The MADRS is a 10-item, clinician-rated scale that evaluates the participant's depressive symptomatology during the past week. Participants are rated on items assessing feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each item will be scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity. Thus, scores in the MADRS range from 0 to 60, with increasing scores indicating increasing severity.
The HAMD-17 was a 17-item clinician-rated instrument used to assess the range of symptoms that were most frequently observed in participants with major depression. All items were scored on an ordinal scale between 0 and 4 (9 items) or 0 and 2 (8 items) of increasing severity. Each of 17 items was rated by clinician with rating of 0: absent, 1: doubtful to mild, 2: mild to moderate, 3: moderate to severe, and 4: very severe. A total score (0 to 52) was calculated by adding scores of all 17 items, where 0 indicated no depression and 52 indicated severe depression. Higher score represents more severe condition. Baseline is defined as the latest non-missing measurement prior to or within 1 hour of the first administration of study drug. Change from Baseline is defined as post dose visit value minus Baseline value.
| Arm | Type | Description |
|---|---|---|
| NMRA-335140 80 milligrams (mg) once daily (QD) | EXPERIMENTAL | Participants will receive a NMRA-335140 tablet at a dose of 80 mg QD |
| Placebo | PLACEBO_COMPARATOR | Placebo participants will receive matching placebo tablet once daily |
| NMRA-335140 (BTRX-335140) | EXPERIMENTAL | NMRA-335140 will be administered. |
| Name | Type | Description |
|---|---|---|
| NMRA-335140 | DRUG | Participants will receive NMRA-335140 at a dose of 80 mg QD, orally |
| Placebo | DRUG | Placebo will be administered orally |
| NMRA-335140 80 mg | DRUG | Participants will receive NMRA-335140 at a dose of 80 mg QD, orally. |
Key Inclusion Criteria: * 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...
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NMRA-335140 is an investigational small molecule being developed for the treatment of Major Depressive Disorder and Major Depressive Episode Associated With Bipolar II Disorder. It is currently in Phase 3 clinical development and has not been approved by regulatory authorities.
NMRA-335140 is being developed by Neumora Therapeutics, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol NMRA. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Major Depressive Disorder.
NMRA-335140 is currently in Phase 3 clinical development for Major Depressive Disorder. The drug is investigational and has not received regulatory approval. Clinical trials are ongoing to assess its safety and effectiveness in treating this condition.
NMRA-335140 has been studied in multiple clinical trials including NCT04221230 (Phase 2, completed), NCT06029426 (Phase 3, completed), NCT06029439 (Phase 3, active but not recruiting), and NCT06058039 (Phase 3, completed). These trials evaluate the drug versus placebo in participants with Major Depressive Disorder.
Yes, NMRA-335140 is also known as BTRX-335140. The Phase 2 clinical trial NCT04221230 was titled 'Study in Major Depressive Disorder With NMRA-335140 (BTRX-335140) vs Placebo', confirming that both names refer to the same investigational drug.