SPN-820 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

Must not have

History of psychotic disorder, including but not limited to schizophrenia, MDD with psychotic features, or bipolar I/II disorder with and without psychotic features

Diagnosis within the last 12 months before screening or current diagnosis of PTSD, OCD, panic disorder, acute stress disorder, or has a history of intellectual disability, autism, or cluster A or B personality disorder

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 days

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new medication called SPN-820 to see if it helps adults with depression feel better when added to their current treatment.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of a psychotic disorder such as schizophrenia or bipolar disorder.

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I was diagnosed with PTSD, OCD, panic disorder, acute stress disorder, or have a history of intellectual disability, autism, or certain personality disorders within the last year.