What is the mechanism of action of this treatment?

Common treatments for depression, such as SSRIs, SNRIs, TCAs, and atypical antipsychotics, primarily work by modulating neurotransmitter levels in the brain, particularly serotonin and norepinephrine. This modulation helps to improve mood and emotional stability, which is essential for alleviating depressive symptoms. Understanding these mechanisms is important for patients as it provides insight into how these medications can help manage their condition and what side effects might be expected. This knowledge also aids clinicians in tailoring treatments to individual needs, enhancing the likelihood of successful outcomes.

What side effects are associated with this type of intervention?

Common treatments for depression, including SSRIs (e.g., fluoxetine, escitalopram), SNRIs (e.g., venlafaxine, duloxetine), tricyclic antidepressants (e.g., amitriptyline), and atypical antidepressants (e.g., bupropion, mirtazapine), have a range of side effects. SSRIs and SNRIs often cause nausea, headache, and insomnia. Tricyclic antidepressants can lead to dry mouth, constipation, urinary retention, and orthostatic hypotension. Atypical antidepressants may cause weight gain, sedation, or agitation.

What prior FDA approvals exist?

The FDA has approved several classes of drugs for the treatment of depression, including selective serotonin reuptake inhibitors (SSRIs) like fluoxetine and sertraline, serotonin-norepinephrine reuptake inhibitors (SNRIs) such as venlafaxine and duloxetine, and tricyclic antidepressants like amitriptyline and imipramine. Atypical antidepressants, including bupropion and mirtazapine, have also been approved. These treatments vary in their mechanisms of action and efficacy, providing multiple options for managing depression.

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SEP-363856 for Major Depressive Disorder

Verified Trial

Phase 2 & 3

Waitlist Available

Research Sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc.

Eligibility Criteria Checklist

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

Must have

Have you been diagnosed with Major Depressive Disorder?

Have you tried at least one antidepressant that hasn't worked?

Must not have

Have you tried 4 or more antidepressants that haven't worked?

Have you been diagnosed with Schizophrenia or Bipolar Disorder or Borderline Personality Disorder or Antisocial Personality Disorder or PTSD or OCD or Panic Disorder or Eating Disorders?

Timeline

Screening 3 weeks

Treatment 8 weeks

Follow Up 1 week

Summary

A Phase 2/3 Trial is designed to evaluate SEP-363856 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder

Who is the study for?

Adults aged 18-65 with major depressive disorder (MDD) who are currently experiencing a depressive episode and have had an inadequate response to 1-3 antidepressant treatments. The current episode should be at least 8 weeks but no more than 2 years long.

What is being tested?

This trial is testing the safety and effectiveness of SEP-363856 as an additional treatment for MDD in adults.

What are the potential side effects?

While specific side effects for SEP-363856 aren't listed here, common side effects from depression medications may include nausea, headache, sleep disturbances, fatigue, dry mouth, blurred vision or dizziness.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ 8 weeksup to 1 visit

Follow Up ~ 1 week1 call or visit

Screening ~ 3 weeks

Treatment ~ 8 weeks

Follow Up ~1 week

This trial's timeline: 3 weeks for screening, 8 weeks for treatment, and 1 week for follow up.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Montgomery Åsberg Depression Rating Scale (MADRS)

Secondary study objectives

Clinical Global Impression - Severity of Illness (CGI-S)

Trial Design

2Treatment groups

Group I: SEP-363856 & ADT (Antidepressant Therapy)

Group II: Placebo & ADT (Antidepressant Therapy)

Group I: SEP-363856 & ADT (Antidepressant Therapy)Experimental Treatment1 Intervention

Group II: Placebo & ADT (Antidepressant Therapy)Placebo Group1 Intervention

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Common treatments for depression, such as SSRIs, SNRIs, TCAs, and atypical antipsychotics, primarily work by modulating neurotransmitter levels in the brain, particularly serotonin and norepinephrine. This modulation helps to improve mood and emotional stability, which is essential for alleviating depressive symptoms. Understanding these mechanisms is important for patients as it provides insight into how these medications can help manage their condition and what side effects might be expected. This knowledge also aids clinicians in tailoring treatments to individual needs, enhancing the likelihood of successful outcomes.

Bulimia nervosa : a review of therapy research.Rapid onset of antidepressant action: a new paradigm in the research and treatment of major depressive disorder.Comparative studies on the efficacy of psychotherapy, pharmacotherapy, and their combination in depression: was adequate pharmacotherapy provided?