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SPN-820 6 x 400 mg capsules for Depression

Phase 2

Recruiting

Research Sponsored by Navitor Pharmaceuticals, Inc.

Eligibility Criteria Checklist

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

Must have

Male or female subject, aged 18 to 65 years (inclusive) at screening

Stable therapeutic dose of the approved ADT throughout the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 days

Awards & highlights

Study Summary

This trial is testing a new drug called SPN-820 to see if it works well and is safe for adults with Major Depressive Disorder (MDD).

Who is the study for?

Adults aged 18-65 with Major Depressive Disorder (MDD) as per DSM-5, having a current depressive episode without psychotic features. Participants must have been on a stable dose of certain antidepressants for at least 4 weeks. Excludes those with significant recent suicidal behavior or ideation, substance abuse history within the last 6 months, and other psychiatric disorders.Check my eligibility

What is being tested?

The trial is testing SPN-820's effectiveness and safety in treating MDD. It involves adults who meet specific criteria related to their depression severity and treatment history.See study design

What are the potential side effects?

While the side effects are not specified here, common ones for new antidepressant treatments can include nausea, headaches, sleep disturbances, agitation or anxiety, sexual dysfunction, and sometimes increased risk of suicidal thoughts.

Eligibility Criteria

Inclusion Criteria

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

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I am between 18 and 65 years old.

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I am on a stable dose of hormone therapy for my condition.

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I have been diagnosed with major depression without psychosis.

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I am moderately ill or worse according to a CGI-S score.

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My depression is severe, with a MADRS score of 22 or higher.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~10 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 days for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Evaluation of the efficacy of SPN-820 administered once every 3 days as measured by the Hamilton Depression Rating Scale-6 Items

Secondary outcome measures

Evaluation of the efficacy as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) score

Trial Design

1Treatment groups

Experimental Treatment

Group I: SPN-820 6 x 400 mg capsulesExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

NV-5138

2018

Completed Phase 1

~80

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Navitor Pharmaceuticals, Inc.Lead Sponsor

3 Previous Clinical Trials

486 Total Patients Enrolled

2 Trials studying Depression

480 Patients Enrolled for Depression

Supernus Pharmaceuticals, Inc.Industry Sponsor

47 Previous Clinical Trials

13,748 Total Patients Enrolled

1 Trials studying Depression

400 Patients Enrolled for Depression

Frequently Asked Questions

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

What is the safety profile of SPN-820, specifically in regards to its administration as six capsules containing 400 mg each?

"Based on the research conducted, our team at Power rates the safety of SPN-820 6 x 400 mg capsules as a level 2. This rating is assigned because it's currently in Phase 2 of clinical trials, indicating that there is limited data supporting its safety but no data supporting its efficacy yet."

Answered by AI

Which individuals are eligible to participate in this research study?

"To be eligible for inclusion in this research endeavor, individuals must meet two criteria: they should have a diagnosis of depression and fall within the age range of 18 to 65 years. The study aims to recruit a total of 50 participants."

Answered by AI

Are individuals currently able to apply and participate in this ongoing research study?

"Based on the information provided by clinicaltrials.gov, this particular study is not currently seeking participants. It was initially posted on February 15th, 2024, and last updated on January 23rd, 2024. However, it's worth noting that there are currently a total of 1362 other trials actively recruiting patients at present."

Answered by AI