Major Depressive Disorder (MDD)Phase 2NCT06836063
Study to Evaluate Efficacy and Safety of Ropanicant in MDD Patients
A Phase 2 study testing Ropanicant in people with Major Depressive Disorder (MDD), run by Suven Life Sciences Limited at 35 sites in United States.
Trial summary
The primary objective is to evaluate the efficacy of Ropanicant at two different dosage levels compared to placebo in patients with 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 (MDD)
- What is being tested?
- Ropanicant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 214 participants
- Where
- 35 sitesUnited States
- Study dates
- 15 Jul 2025to 23 Feb 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Patients must meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria for MDD without psychotic features based on the Mini International Neuropsychiatric Interview (MINI) with a current major depressive episode of at least 4 weeks of duration but no longer than 12 months.
- Patients must have a Clinical Global Impression-Severity (CGI-S) score of ≥4.
- Patients must have a Structured Interview Guide for the Hamilton Depression Rating Scale (SIGH-D) score of ≥20.
- Patients must have a Snaith-Hamilton Pleasure Scale (SHAPS) score of ≥20.
- Patients must have vision and hearing (corrected if needed) sufficient to comply with the testing procedures.
Who cannot join
- Patients who meet criteria for treatment-resistant depression (TRD) during the current major depressive episode, which is defined as being nonresponders (<50% of symptom improvement) to 2 or more depression treatment periods of adequate dose and duration.
- Patients not in good general health with clinically significant abnormalities as assessed by the investigator and determined by physical examination results, neurological examination results, ECG results, or laboratory assessments.
- Female patients who are pregnant, planning to become pregnant during the study or within 30 days after the last administration of study drug, or breastfeeding.
- Patients with bradycardia (<50 bpm) or tachycardia (>100 bpm) on the ECG results.
Trial locations and contacts
35 sites in 1 country.
35 sites in 1 country
United States35 sites
Advanced Research Center, Inc.
Anaheim, California, 92805
Atlanta Center for Medical Research
Atlanta, Georgia, 30331
Community Clinical Research, Inc.
Austin, Texas, 78754
Neurobehavioral Medicine Group
Bloomfield Hills, Michigan, 48302
SPRI Clinical Trials, LLC
Brooklyn, New York, 11235
Neurobehavioral Research Inc.
Cedarhurst, New York, 11516
Center for Emotional Fitness
Cherry Hill, New Jersey, 08002
Chicago Research Center Inc.
Chicago, Illinois, 60634
ProScience Research Group
Culver City, California, 90230
CenExcel iResearch LLC
Decatur, Georgia, 30030
Core Clinical Research
Everett, Washington, 98201
Precise Research Centers
Flowood, Mississippi, 39232
North Texas Clinical Trials, LLC
Fort Worth, Texas, 76104
Behavioral Research Specialists, LLC
Glendale, California, 91206
Memorial Hermann Village
Houston, Texas, 77043
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, 32256
Redbird Research, LLC
Las Vegas, Nevada, 89119
Vector Clinical Trials
Las Vegas, Nevada, 89128
Synergy San Diego
Lemon Grove, California, 91945
Woodland International Research Group LLC
Little Rock, Arkansas, 72211
Hassman Research Institue
Marlton, New Jersey, 08053
Clinical Neuroscience Solutions Inc.
Memphis, Tennessee, 38119
Premier Clinical Research Institute, Inc
Miami, Florida, 33122
Excell Research, Inc.
Oceanside, California, 92056
Sooner Clinical Research, Inc
Oklahoma City, Oklahoma, 73116
ATP Clinical Research
Orange, California, 92866
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32801
Panhandle Research and Medical Clinic LLC
Pensacola, Florida, 32503
Eximia Research-NC, LLC
Raleigh, North Carolina, 27607
Woodland Research Northwest
Rogers, Arkansas, 72758
Midwest Research Group
Saint Charles, Missouri, 63304
CenExcel iResearch LLC
Savannah, Georgia, 31405
Richmond Behavioral Associates
Staten Island, New York, 10312
ForCare Clinical Research
Tampa, Florida, 33613
Collaborative Neuroscience Research
Torrance, California, 90504
About this study
Official title: A Phase 2b, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Trial to Evaluate Efficacy and Safety of Ropanicant in Patients With Major Depressive Disorder
The primary objective is to evaluate the efficacy of Ropanicant at two different dosage levels compared to placebo in patients with Major Depressive Disorder (MDD).
Read the detailed description
This is a Phase 2b, randomized, double-blind, placebo-controlled, parallel-group, multicenter trial to evaluate the efficacy and safety of Ropanicant versus placebo in patients with MDD. The study will be conducted at multiple centers located in the US.
This study consists of a 4-weeks screening period, 6-weeks treatment period, and a 2-weeks follow-up period. Approximately 195 patients will be randomly assigned to receive Ropanicant Dose Level 1 bid or Dose Level 2 bid, or placebo bid for 6 weeks in a ratio of 1:1:1 (65 patients in each treatment group).
- Conditions
- Major Depressive Disorder (MDD)
- Being tested
- Ropanicant, Placebo
- Keywords
- SUVN-911, α4β2, Ropanicant, MDD
- Medical subject headings
- Depressive Disorder, Major
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 dosage form, twice a day
PlaceboDrug
Matching placebo tablets, twice a day
| Study group | Role | What they receive |
|---|---|---|
| Ropanicant Dose Level 1 | Experimental | Not described Receives: Drug: Ropanicant |
| Ropanicant Dose Level 2 | Experimental | Not described Receives: Drug: Ropanicant |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total score at Week 6
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.
Measured: Baseline to Week 6
Secondary outcomes (1)
Change from Baseline in Clinical Global Impression-Severity (CGI-S) score at Week 6
The CGI-S will be used to rate the severity of each patient's illness related to depressive symptoms on a 7-point scale, which includes the following gradations: 1 = normal, not at all ill; 2 = borderline ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill.
Measured: Baseline to Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start15 Jul 2025
- Primary completion23 Feb 2026
- Study completion23 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive Disorder (MDD)Studies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suven Life Sciences Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06836063
- Sponsor's protocol ID
- CTP2S2911A4B2
- Status last verified
- Apr 2026
- First submitted
- 18 Feb 2025
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Differding E. India's Drug Discovery and Development Industry: The Quest for Novel Therapeutic Treatments. ChemMedChem. 2026 Jun 15;21(11):e70304. doi: 10.1002/cmdc.70304.
PubMed 42289374
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Trial to Evaluate Efficacy and Safety of Ropanicant in Patients With Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT06836063
- Acronym / sponsor ID
- CTP2S2911A4B2
- Conditions
- Major Depressive Disorder (MDD)
- Keywords
- SUVN-911, α4β2, Ropanicant, MDD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- Suven Life Sciences LimitedIndustry (pharma, biotech, devices)
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- 23 Feb 2026 (actual)
- Study completion
- 23 Feb 2026 (actual)
- First posted
- 20 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective is to evaluate the efficacy of Ropanicant at two different dosage levels compared to placebo in patients with Major Depressive Disorder (MDD).
Detailed description
This is a Phase 2b, randomized, double-blind, placebo-controlled, parallel-group, multicenter trial to evaluate the efficacy and safety of Ropanicant versus placebo in patients with MDD. The study will be conducted at multiple centers located in the US.
This study consists of a 4-weeks screening period, 6-weeks treatment period, and a 2-weeks follow-up period. Approximately 195 patients will be randomly assigned to receive Ropanicant Dose Level 1 bid or Dose Level 2 bid, or placebo bid for 6 weeks in a ratio of 1:1:1 (65 patients in each treatment group).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ropanicant Dose Level 1 | Experimental | Drug: Ropanicant |
| Ropanicant Dose Level 2 | Experimental | Drug: Ropanicant |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients must meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria for MDD without psychotic features based on the Mini International Neuropsychiatric Interview (MINI) with a current major depressive episode of at least 4 weeks of duration but no longer than 12 months.
- Patients must have a Clinical Global Impression-Severity (CGI-S) score of ≥4.
- Patients must have a Structured Interview Guide for the Hamilton Depression Rating Scale (SIGH-D) score of ≥20.
- Patients must have a Snaith-Hamilton Pleasure Scale (SHAPS) score of ≥20.
- Patients must have vision and hearing (corrected if needed) sufficient to comply with the testing procedures.
Key exclusion criteria (4 listed)
- Patients who meet criteria for treatment-resistant depression (TRD) during the current major depressive episode, which is defined as being nonresponders (<50% of symptom improvement) to 2 or more depression treatment periods of adequate dose and duration.
- Patients not in good general health with clinically significant abnormalities as assessed by the investigator and determined by physical examination results, neurological examination results, ECG results, or laboratory assessments.
- Female patients who are pregnant, planning to become pregnant during the study or within 30 days after the last administration of study drug, or breastfeeding.
- Patients with bradycardia (<50 bpm) or tachycardia (>100 bpm) on the ECG results.
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 dosage form, twice a day | Drug | Ropanicant Dose Level 1, Ropanicant Dose Level 2 |
| PlaceboMatching placebo tablets, twice a day | Drug | Placebo |
Primary outcome
Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total score at Week 6
Time frame: Baseline to Week 6
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.
1 secondary outcome
Change from Baseline in Clinical Global Impression-Severity (CGI-S) score at Week 6
Time frame: Baseline to Week 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Derived from this study: PubMed 42289374Differding E. India's Drug Discovery and Development Industry: The Quest for Novel Therapeutic Treatments. ChemMedChem. 2026 Jun 15;21(11):e70304. doi: 10.1002/cmdc.70304.
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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.
35 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 (MDD), run by Suven Life Sciences Limited at 35 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 5 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 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total score at Week 6 (time frame: Baseline to Week 6). 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 NCT06836063, which also lists 1 linked publication.
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 7 Apr 2026.