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Ropanicant 30 mg bid for Depression

Phase 2

Recruiting

Research Sponsored by Suven Life Sciences Limited

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must have a score of ≥4 on Clinical Global Impression - Severity (CGI-S) Scale at the screening and the baseline visits.

Participants must meet the DSM-5 criteria for MDD without psychotic features and diagnosis confirmed by the Mini-International Neuropsychiatric Interview (MINI).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from screening to day 21

Awards & highlights

Study Summary

This trial is testing the safety and effectiveness of a drug called ropanicant in people with moderate to severe depression.

Who is the study for?

This trial is for individuals with moderate to severe Major Depressive Disorder (MDD) who have been feeling depressed for at least 4 weeks. They should score high on depression severity scales and meet specific diagnostic criteria without having psychotic features.Check my eligibility

What is being tested?

The study is testing the safety and effectiveness of a medication called Ropanicant in treating MDD. It's an open-label, parallel-group study, meaning participants know they're receiving Ropanicant and are compared with others in separate groups.See study design

What are the potential side effects?

While the side effects of Ropanicant are not detailed here, similar medications often cause nausea, headaches, dizziness, sleep disturbances or changes in appetite. Participants will be monitored for any adverse reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My condition is considered moderately severe or worse.

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I have been diagnosed with major depression without psychosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from screening to day 21

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from screening to day 21

This trial's timeline: 3 weeks for screening, Varies for treatment, and from screening to day 21 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Secondary outcome measures

Montgomery-Åsberg Depression Rating Scale (MADRS) score.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Ropanicant 45 mg qdExperimental Treatment1 Intervention

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

Group II: Ropanicant 45 mg bidExperimental Treatment1 Intervention

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

Group III: Ropanicant 30 mg bidExperimental Treatment1 Intervention

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Suven Life Sciences LimitedLead Sponsor

11 Previous Clinical Trials

1,400 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available slots for patients to participate in this research study?

"Indeed, as per the details on clinicaltrials.gov, this investigation is presently seeking eligible candidates. The trial was initially posted on January 1st, 2024 and last edited on January 20th, 2024."

Answered by AI

What is the upper limit for the number of individuals enrolled in this clinical investigation?

"Indeed, the details on clinicaltrials.gov indicate that this study is actively seeking eligible participants. The trial was originally posted on January 1st, 2024 and last updated on January 20th, 2024. In total, the study aims to recruit a cohort of 36 patients from three distinct locations."

Answered by AI

Has the Food and Drug Administration given their approval for a dosage of 45 mg of Ropanicant to be taken twice daily?

"Based on the evaluation by our team at Power, we assign a safety rating of 2 to Ropanicant 45 mg bid. This assessment is based on it being a Phase 2 trial, indicating that there is preliminary data supporting its safety but no evidence yet regarding its effectiveness."

Answered by AI

Is the age threshold for eligibility in this study set at 45 years and above?

"The eligibility criteria for this clinical trial specify that eligible candidates should be between the ages of 18 and 65. It is worth noting that there are a total of 216 trials available for individuals under the age of 18, as well as 996 trials catering to patients over the age of 65."

Answered by AI

Who else is applying?

What site did they apply to?

Collaborative Neuroscience Research, LLC

Innovative Clinical Research, Inc.

What portion of applicants met pre-screening criteria?

Did not meet criteria

Met criteria

Why did patients apply to this trial?

I’ve tried multiple medications and they have not worked. I’ve tried several drugs and although I have gotten some relief, I’ve always had side effects of becoming cold and unemotional and completely shut down.

PatientReceived 1 prior treatment

Recent research and studies

clinicaltrials.govStudy

Study Evaluating Safety and Efficacy of Ropanicant in MDD Patients

2024. "Study Evaluating Safety and Efficacy of Ropanicant in MDD Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06126497.

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