Major Depressive DisorderPhase 2NCT06126497

Study Evaluating Safety and Efficacy of Ropanicant in MDD Patients

A Phase 2 study testing Ropanicant in people with Major Depressive Disorder, run by Suven Life Sciences Limited at 10 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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). Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Major Depressive Disorder
What is being tested?: Ropanicant
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 41 participants
Where: 10 sitesUnited States
Study dates: 5 Feb 2024to 19 Jul 2024
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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 locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

United States10 sites

Clinical Innovations, Inc
Bellflower, California, 90706
CenExel iResearch, LLC
Decatur, Georgia, 30030
Eastside Therapeutic Resource, Inc. dba Core Clinical Research
Everett, Washington, 98201
Precise Research Centers
Flowood, Mississippi, 39232
Innovative Clinical Research, Inc.
Miami Lakes, Florida, 33016
Cedar Clinical Research, Inc.
Murray, Utah, 84107
Neuro behavioral Clinical Research, Inc
North Canton, Ohio, 44720
NRC Research Institute
Orange, California, 92868
CenExel iResearch, LLC
Savannah, Georgia, 31405
Collaborative Neuroscience Research, LLC
Torrance, California, 90504

Other trials in United States

About this study

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

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).

Read the detailed description

Approximately 36 participants will be randomly assigned to receive Ropanicant either Ropanicant 45 mg once a day (QD), Ropanicant 30 mg twice a day (BID), or Ropanicant 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: Major Depressive Disorder
Being tested: Ropanicant
Keywords: SUVN-911, Phase-2, MDD, Depression, Open label
Medical subject headings: Depressive Disorder, Major, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RopanicantDrug
Also called SUVN-911
Tablet

Study groups in NCT06126497
Study group	Role	What they receive
Ropanicant 45 mg QD	Experimental	The participant will take 1 tablet/day in the morning (for qd dosing) Receives: Drug: Ropanicant
Ropanicant 30 mg BID	Experimental	The participant will take 2 tablets/day (~12 hours apart for bid dosing). Receives: Drug: Ropanicant
Ropanicant 45 mg BID	Experimental	The participant will take 2 tablets/day (~12 hours apart for bid dosing). Receives: Drug: Ropanicant

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Treatment-Emergent Adverse Events
Participants with at least one Treatment-emergent adverse events (TEAEs) reported during the duration of the study.
Measured: From Screening to Day 21

Secondary outcomes (1)

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 of 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.
Measured: From Baseline to Day 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Feb 202419 Jul 2024

First posted13 Nov 2023
Study start5 Feb 2024
Primary completion19 Jul 2024
Study completion19 Jul 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Open label study
Masking: None (open label)
Enrolment: 41 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06126497
Sponsor's protocol ID: CTP2S1911A4B2
Status last verified: Aug 2026
First submitted: 6 Nov 2023
Last updated: 1 Sep 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Major Depressive Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label Study Evaluating the Safety and Efficacy of Ropanicant in Participants With Moderate to Severe Major Depressive Disorder
ClinicalTrials.gov ID: NCT06126497
Acronym / sponsor ID: CTP2S1911A4B2
Conditions: Major Depressive Disorder
Keywords: SUVN-911, Phase-2, MDD, Depression, Open label
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 41 participants (actual)
Lead sponsor: Suven Life Sciences LimitedIndustry (pharma, biotech, devices)
Study start: 5 Feb 2024 (actual)
Primary completion: 19 Jul 2024 (actual)
Study completion: 19 Jul 2024 (actual)
First posted: 13 Nov 2023 (actual)
Results: Posted 1 Sep 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
Model description: Open label study

Arm	Type	Receives
Ropanicant 45 mg QD	Experimental	Drug: RopanicantThe participant will take 1 tablet/day in the morning (for qd dosing)
Ropanicant 30 mg BID	Experimental	Drug: RopanicantThe participant will take 2 tablets/day (~12 hours apart for bid dosing).
Ropanicant 45 mg BID	Experimental	Drug: RopanicantThe participant will take 2 tablets/day (~12 hours apart for bid dosing).

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RopanicantAlso: SUVN-911Tablet	Drug	Ropanicant 30 mg BID, Ropanicant 45 mg BID, Ropanicant 45 mg QD

Primary outcome

Number of Participants With Treatment-Emergent Adverse Events
Time frame: From Screening to Day 21
Participants with at least one Treatment-emergent adverse events (TEAEs) reported during the duration of the study.

1 secondary outcome

Montgomery-Åsberg Depression Rating Scale (MADRS) Score
Time frame: From Baseline to Day 14

Results and safety

Results posted to the registry on 1 Sep 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ropanicant 45 mg, QD	14	12
Ropanicant 30 mg, BID	14	12
Ropanicant 45 mg, BID	13	13

Primary outcome: Number of Participants With Treatment-Emergent Adverse Events

Time frame: From Screening to Day 21. Count of participants. Unit: Participants

Measure	Ropanicant 45 mg, QD n = 14	Ropanicant 30 mg, BID n = 13	Ropanicant 45 mg, BID n = 13
Value	6	6	6

Population analysed: The analysis population considered is Safety Set which included all participants who received any study drug.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From Screening to Day 21. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ropanicant 45 mg, QD	0 of 14 (0%)	6 of 14 (42.9%)	0 of 14
Ropanicant 30 mg, BID	0 of 13 (0%)	6 of 13 (46.2%)	0 of 13
Ropanicant 45 mg, BID	0 of 13 (0%)	6 of 13 (46.2%)	0 of 13

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

10 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ropanicant in people with Major Depressive Disorder, run by Suven Life Sciences Limited at 10 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Treatment-Emergent Adverse Events (time frame: From Screening to Day 21). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06126497.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.