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.

SEP-363856 for Major Depressive Disorder

Verified Trial

Orlando, FL

Phase 2 & 3

Recruiting

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

Be older than 18 years old

Must not have

Have you been diagnosed with Schizophrenia?

Have you been diagnosed with Bipolar Disorder?

Timeline

Screening 3 weeks

Study 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

See full description

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. Check my eligibility

What is being tested?

This trial is testing the safety and effectiveness of SEP-363856 as a potential additional treatment for MDD in adults.See study design

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

Exclusion Criteria

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

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Have you been diagnosed with Schizophrenia?

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Have you been diagnosed with Bipolar Disorder?

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Have you been diagnosed with Obsessive-Compulsive Disorder?

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Are you a daily user of marijuana? Answer NO if you are willing to stop for the 19-week duration of the study

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Have you been diagnosed with Epilepsy or Seizures?

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Have you tried 3 or more antidepressant medications during this depressive episode that haven’t helped your depression symptoms?

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In the last year, have you taken any antipsychotic medication?

Timeline

Screening ~ 3 weeks3 visits

Study Treatment ~ 8 weeksup to 1 visit

Follow Up ~ 1 week1 call or visit

Screening ~ 3 weeks

Study Treatment ~ 8 weeks

Follow Up ~1 week

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

Study 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 / 7Eligibility 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.