Trial · NCT06029439
Study to Assess the Safety and Effectiveness of NMRA-335140-501
NCT06029439, Phase 3, Terminated, Neumora Therapeutics, Inc.
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Study to Assess the Safety and Effectiveness of NMRA-335140-501. Trials, record NCT06029439. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06029439
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Assess the Safety and Effectiveness of NMRA-335140-501
- NCT number
- NCT06029439
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 904 participants, actual
- Lead sponsor
- Neumora Therapeutics, Inc.
- Conditions
- Major Depressive Disorder
- Interventions
- NMRA-335140
- First posted
- 2023-09-08
- Last updated
- 2026-09-14
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety and tolerability assessments based on Treatment Emergent Adverse Events (TEAEs) and validated clinical scales | Up to 54 Weeks | 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. |
| Secondary | Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total score over time. | Baseline and up to Week 54 | Change from baseline in MADRS total score over time will be reported. The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The scale consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total score of 60. Higher scores represent a more severe condition. |
| Secondary | Change from Baseline in the Snaith-Hamilton Pleasure Scale (SHAPS) total score over time | Baseline and up to Week 54 | The SHAPS is a 14-item participant-reported instrument which measures anhedonia. It has been shown to be valid and reliable in normal and clinical samples, with adequate construct validity, satisfactory test-retest reliability, and high internal consistency. The scale will be completed by the participant and reviewed by site personnel qualified to oversee completeness. Each of the 14 items has a set of 4 responses, 2 of which endorse agreement (Definitely Agree, Agree) and 2 of which endorse disagreement (Disagree, Strongly Disagree). A total score can be derived by summing the responses; items answered with strongly agree are coded as 1 while a strongly disagree response will be coded as 4. Therefore, scores on the SHAPS can range from 14 to 56, with higher scores corresponding to higher levels of anhedonia. |
| Secondary | Change from Baseline in the Patient Health Questionnaire-9 (PHQ-9) total score over time. | Baseline and up to Week 54 | Change from baseline in PHQ-9 total score over time will be reported. The 9-item PHQ-9 scale scores each of the 9 symptom domains of the Diagnostic and Statistical Manual of Mental Disorders-5th Edition (DSM-5) diagnostic criteria for recurrent or single episode major depressive disorder (MDD) criteria and used both as a screening tool and a measure of response to treatment for depression. 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. |
| Secondary | Change from Baseline in PHQ-9 Anhedonia Item #1 over time. | Baseline and up to Week 54 | The PHQ-9 is a participant-rated assessment scale for the evaluation of depression symptoms over the past 2 weeks. The PHQ-9 is a reliable and valid measure of depression and depression severity. The questionnaire consists of 9 items and each item is scored from 0 to 3. Participants will be asked how often they have been bothered by symptoms over the past 2 weeks (Not at all \[0\], Several days \[1\], More than half the time \[2\], or Nearly every day \[3\]). Higher scores indicate higher levels of depression. |
| Secondary | Change from Baseline in the Hamilton Anxiety Rating Scale (HAM-A) total score over time. | Baseline and up to Week 54 | The HAM-A is a clinician-rated instrument administered to assess severity of anxiety, its improvement during the course of treatment, and the timing of such improvement. This instrument will be completed by qualified and trained Investigator site raters based on a semi-structured interview for his/her assessment of the participant. The scale consists of 14 items. Each item is rated on a scale of 0 (feeling not present) to 4 (very severe prevalence of the feeling). The HAM-A total score is the sum of the 14 items and the score ranges from 0 to 56. |
| Secondary | Change from Baseline in the Clinical Global Impression Scale of Severity (CGI-S) | Baseline and up to Week 54 | Change from baseline in the CGI-S total score over time will be reported. The CGI-S evaluates the severity of psychopathology on a scale of 0 to 7. Considering total clinical experience, a participant is assessed on severity of mental illness at the time of rating according to: 0=not assessed; 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill participants. The CGI-S permits a global evaluation of the participant's condition at a given time. |
| Secondary | Clinical Global Impression Scale of Improvement (CGI-I) score at each timepoint | Baseline and up to Week 54 | The CGI-I scale is a clinician-rated instrument that measures the improvement of the participant's symptoms of depression. It is a 7-point scale where a score of 1 indicates that the participant is "very much improved," a score of 4 indicates that the participant has experienced "no change," and a score of 7 indicates that the participant is "very much worse." |
| Secondary | Percentage of participants whose MADRS total score decreased by greater than or equal to 50% from Baseline over time | Up to Week 54 | |
| Secondary | Percentage of participants whose MADRS total score decreased to 10 or less over time | Up to Week 54 |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06029439
GET https://conductscience.org/api/trials/v1/NCT06029439/registered