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

Conditions

Major Depressive Disorder

Brief summary

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).

Detailed description

Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score over time., Change from baseline in the Snaith-Hamilton Pleasure Scale (SHAPS) total score over time., Change from baseline in the Patient Health Questionnaire-9 (PHQ-9) total score over time., Change from baseline in PHQ-9 Anhedonia Item #1 over time., Change from baseline in the Hamilton Anxiety Rating Scale (HAM-A) total score over time., Change from baseline in the Clinical Global Impression of Severity (CGI-S) score over time, Value at each timepoint assessed in the Clinical Global Impression of Improvement (CGI-I) score., Percentage of participants whose MADRS total score decreased by greater than or equal to 50% from baseline over time., Percentage of participants whose MADRS total score decreased to 10 or less over time., Change from baseline in the Sheehan Disability Scale (SDS) over time.

Related papers

No related papers found yet.

Interventions

DRUGNMRA-335140

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
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).	—

Secondary

Measure	Time frame
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score over time., Change from baseline in the Snaith-Hamilton Pleasure Scale (SHAPS) total score over time., Change from baseline in the Patient Health Questionnaire-9 (PHQ-9) total score over time., Change from baseline in PHQ-9 Anhedonia Item #1 over time., Change from baseline in the Hamilton Anxiety Rating Scale (HAM-A) total score over time., Change from baseline in the Clinical Global Impression of Severity (CGI-S) score over time, Value at each timepoint assessed in the Clinical Global Impression of Improvement (CGI-I) score., Percentage of participants whose MADRS total score decreased by greater than or equal to 50% from baseline over time., Percentage of participants whose MADRS total score decreased to 10 or less over time., Change from baseline in the Sheehan Disability Scale (SDS) over time.	—

Measure

Time frame

Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score over time., Change from baseline in the Snaith-Hamilton Pleasure Scale (SHAPS) total score over time., Change from baseline in the Patient Health Questionnaire-9 (PHQ-9) total score over time., Change from baseline in PHQ-9 Anhedonia Item #1 over time., Change from baseline in the Hamilton Anxiety Rating Scale (HAM-A) total score over time., Change from baseline in the Clinical Global Impression of Severity (CGI-S) score over time, Value at each timepoint assessed in the Clinical Global Impression of Improvement (CGI-I) score., Percentage of participants whose MADRS total score decreased by greater than or equal to 50% from baseline over time., Percentage of participants whose MADRS total score decreased to 10 or less over time., Change from baseline in the Sheehan Disability Scale (SDS) over time.

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Countries

Bulgaria, Czechia, Finland, France, Germany, Poland, Sweden

Outcome results

None listed