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Study Evaluating Safety and Efficacy of Ropanicant in MDD Patients

NCT ID: NCT06126497

Last Updated: 2024-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-05

Study Completion Date

2024-07-19

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.

Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Open label study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ropanicant 45 mg qd

The participant will take 1 tablet/day in the morning (for qd dosing)

Group Type EXPERIMENTAL

Ropanicant

Intervention Type DRUG

Tablet

Ropanicant 30 mg bid

The participant will take 2 tablets/day (\~12 hours apart for bid dosing).

Group Type EXPERIMENTAL

Ropanicant

Intervention Type DRUG

Tablet

Ropanicant 45 mg bid

The participant will take 2 tablets/day (\~12 hours apart for bid dosing).

Group Type EXPERIMENTAL

Ropanicant

Intervention Type DRUG

Tablet

Interventions

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Ropanicant

Tablet

Intervention Type DRUG

Other Intervention Names

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SUVN-911

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Suven Life Sciences Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Clinical Innovations, Inc

Bellflower, California, United States

Site Status

NRC Research Institute

Orange, California, United States

Site Status

Collaborative Neuroscience Research, LLC

Torrance, California, United States

Site Status

Innovative Clinical Research, Inc.

Miami Lakes, Florida, United States

Site Status

CenExel iResearch, LLC

Decatur, Georgia, United States

Site Status

CenExel iResearch, LLC

Savannah, Georgia, United States

Site Status

Precise Research Centers

Flowood, Mississippi, United States

Site Status

Neuro behavioral Clinical Research, Inc

North Canton, Ohio, United States

Site Status

Cedar Clinical Research, Inc.

Murray, Utah, United States

Site Status

Eastside Therapeutic Resource, Inc. dba Core Clinical Research

Everett, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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CTP2S1911A4B2

Identifier Type: -

Identifier Source: org_study_id