Study Evaluating Safety and Efficacy of Ropanicant in MDD Patients

Phase 2

Completed

• Conditions: Major Depressive Disorder
• Interventions: Drug: Ropanicant

• Registration Number: NCT06126497
• Lead Sponsor: Suven Life Sciences Limited

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2023-11-06
• Study First Submitted QC: 2023-11-06
• Study First Posted: 2023-11-13
• Study Start: 2024-02-05
• Primary Completion: 2024-07-19
• Study Completion: 2024-07-19
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-29
• Last Update Posted: 2024-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ropanicant 45 mg qd	Ropanicant	The participant will take 1 tablet/day in the morning (for qd dosing)
Ropanicant 30 mg bid	Ropanicant	The participant will take 2 tablets/day (\~12 hours apart for bid dosing).
Ropanicant 45 mg bid	Ropanicant	The participant will take 2 tablets/day (\~12 hours apart for bid dosing).

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Montgomery-Åsberg Depression Rating Scale (MADRS) score.	From Baseline to Day 14	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.

Trial Locations

Locations (9)

Clinical Innovations, Inc; 🇺🇸 Bellflower, California, United States

Collaborative Neuroscience Research, LLC; 🇺🇸 Torrance, California, United States

NRC Research Institute; 🇺🇸 Orange, California, United States

CenExel iResearch, LLC; 🇺🇸 Savannah, Georgia, United States

Precise Research Centers; 🇺🇸 Flowood, Mississippi, United States

Innovative Clinical Research, Inc.; 🇺🇸 Miami Lakes, Florida, United States

Neuro behavioral Clinical Research, Inc; 🇺🇸 North Canton, Ohio, United States

Cedar Clinical Research, Inc.; 🇺🇸 Murray, Utah, United States

Eastside Therapeutic Resource, Inc. dba Core Clinical Research; 🇺🇸 Everett, Washington, United States