Clinical trial NCT06126497: Study Evaluating Safety and Efficacy of Ropanicant in MDD Patients
Official title: An Open-Label Study Evaluating the Safety and Efficacy of Ropanicant in Participants With Moderate to Severe Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Major Depressive Disorder
Keywords: SUVN-911
Phase-2
MDD
Depression
Open label
Lead sponsor: Suven Life Sciences Limited
Sponsor class: INDUSTRY
First posted: 2023-11-13
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open label study
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: From Screening to Day 21
Secondary outcomes:
measure: Montgomery-Åsberg Depression Rating Scale (MADRS) score.
timeFrame: From Baseline to Day 14
Other outcomes:
Locations:
city: Bellflower
country: United States
facility: Clinical Innovations, Inc
state: California
city: Orange
country: United States
facility: NRC Research Institute
state: California
city: Torrance
country: United States
facility: Collaborative Neuroscience Research, LLC
state: California
city: Miami Lakes
country: United States
facility: Innovative Clinical Research, Inc.
state: Florida
city: Decatur
country: United States
facility: CenExel iResearch, LLC
state: Georgia
city: Savannah
country: United States
facility: CenExel iResearch, LLC
state: Georgia
city: Flowood
country: United States
facility: Precise Research Centers
state: Mississippi
city: North Canton
country: United States
facility: Neuro behavioral Clinical Research, Inc
state: Ohio
city: Murray
country: United States
facility: Cedar Clinical Research, Inc.
state: Utah
city: Everett
country: United States
facility: Eastside Therapeutic Resource, Inc. dba Core Clinical Research
state: Washington
Study officials:
References: