Study Evaluating Safety and Efficacy of Ropanicant in MDD Patients

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06126497
• Other study ID #: CTP2S1911A4B2
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: February 5, 2024
• Est. completion date: August 2024

Study information

• Verified date: April 2024
• Source: Suven Life Sciences Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 41
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• Ropanicant
Tablet

Locations

Country	Name	City	State
United States	Clinical Innovations, Inc	Bellflower	California
United States	CenExel iResearch, LLC	Decatur	Georgia
United States	Eastside Therapeutic Resource, Inc. dba Core Clinical Research	Everett	Washington
United States	Precise Research Centers	Flowood	Mississippi
United States	Innovative Clinical Research, Inc.	Miami Lakes	Florida
United States	Cedar Clinical Research, Inc.	Murray	Utah
United States	Neuro behavioral Clinical Research, Inc	North Canton	Ohio
United States	NRC Research Institute	Orange	California
United States	CenExel iResearch, LLC	Savannah	Georgia
United States	Collaborative Neuroscience Research, LLC	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
Suven Life Sciences Limited

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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