Study Evaluating Safety and Efficacy of Ropanicant in MDD Patients

Study Overview
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Brief Summary
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This is an open-label, parallel-group study to evaluate the safety and efficacy of ropanicant in participants with moderate to severe Major Depressive Disorder (MDD).

Detailed Description
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Approximately 36 participants will be randomly assigned to receive ropanicant either 45 mg qd, 30 mg bid, or 45 mg bid for 2 weeks, in a ratio of 1:1:1 (12 participants in each treatment group). Following a screening period of up to 4 weeks, the participants will be treated for 2 weeks.

Official Title
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An Open-Label Study Evaluating the Safety and Efficacy of Ropanicant in Participants With Moderate to Severe Major Depressive Disorder

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Drug: Ropanicant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants must meet the DSM-5 criteria for MDD without psychotic features and diagnosis confirmed by the Mini-International Neuropsychiatric Interview (MINI). Participants with a current major depressive episode of at least 4 weeks of duration prior to the screening visit. Participants must have an MADRS score of ≥25 at the screening and the baseline visits. Participants must have a score of ≥4 on Clinical Global Impression - Severity (CGI-S) Scale at the screening and the baseline visits. Exclusion Criteria: Participants who meet criteria for treatment-resistant depression during the current major depressive episode, which will be defined as being non-responders (less than 50% of symptom improvement) to 2 or more depression treatment periods of adequate dose and duration as defined by the Massachusetts General Hospital (MGH) Antidepressant Treatment Response Questionnaire (ATRQ). Participants taking antidepressant treatment (SSRIs and SNRIs) or any medication that is contraindicated with the use of monoamine oxidase inhibitors (eg, opioids, stimulants) within 2 weeks (or 5 half-lives, whichever is longer) prior to baseline and until the end of study visit. Participants who do not agree to avoid tyramine rich diet from the start of dosing and until 2 weeks following last study drug administration. Participants who are habitual smokers or using nicotine products.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ropanicant 45 mg qd<br>The participant will take 1 tablet/day in the morning (for qd dosing) | Drug: Ropanicant<br>* Tablet<br>* Other names: SUVN-911;|
| Experimental: Ropanicant 30 mg bid<br>The participant will take 2 tablets/day ( 12 hours apart for bid dosing). | Drug: Ropanicant<br>* Tablet<br>* Other names: SUVN-911;|
| Experimental: Ropanicant 45 mg bid<br>The participant will take 2 tablets/day ( 12 hours apart for bid dosing). | Drug: Ropanicant<br>* Tablet<br>* Other names: SUVN-911;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Frequency and severity of adverse events, treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuations. | From Screening to Day 21 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Montgomery-Åsberg Depression Rating Scale (MADRS) score. | Change from the baseline to the MADRS total score. The MADRS is a clinician-rated scale to assess depressive symptoms which consists from 10 items. The time frame for this scale is the past 7 days. Each item is scored on 7-point scale (0 [absence of symptoms] to 6 [severe]). The total score is the sum of 10 items and can take range from 0 to 60. A higher score represents a higher severity of the level of depression. | From Baseline to Day 14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SUVN-911, MDD, Depression, Open label, Phase-2