Study Evaluating Safety and Efficacy of Ropanicant in MDD Patients

Suven Life Sciences

Status and phase: Active, not recruiting; Phase 2

Conditions: Major Depressive Disorder

Treatments: Drug: Ropanicant

Study type: Interventional

Funder types: Industry

Identifiers

NCT06126497

CTP2S1911A4B2

Details and patient eligibility

About

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).

Full 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.

Enrollment: 41 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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41 participants in 3 patient groups

Ropanicant 45 mg qd

Experimental group

Description:

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

Treatment:

Drug: Ropanicant

Ropanicant 30 mg bid

Experimental group

Description:

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

Treatment:

Drug: Ropanicant

Ropanicant 45 mg bid

Experimental group

Description:

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

Treatment:

Drug: Ropanicant