A Randomized, Double-blind, Active-controlled Trial to Assess the Efficacy and Safety of AXS-05 Administered Orally to Subjects with Treatment Resistant Major Depressive Disorder

  • STATUS
    Recruiting
  • participants needed
    10
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Updated on 19 February 2024

Summary

We are currently enrolling participants for a clinical research study to look at the effectiveness and safety of an investigational medication AXS-05 (a combination of bupropion and dextromethorphan) compared to bupropion (Approved by FDA), in patients with depression who have not responded to prior treatment with at least one antidepressant. If you are eligible for this study and choose to participate, you will receive all study visits and study-related medical care at no cost to you. Compensation for your time and travel may also be provided.

Description

Study participation will last up to 14 weeks which will include 2 weeks screening period, 6 weeks open label period (all the patients will receive bupropion), and 6 weeks double blind period (randomized either to bupropion or study medication).

FAQ

You may be able to take part in this study if you: • are between 18 and 65 years of age • Diagnosed with depression • Experiencing depression symptoms despite having taken one or two antidepressant medications in the past • Able to provide written consent to participate in the study. The study doctor will discuss additional requirements for being in the study with you.

Details
Condition Depression, Major depression, Depression, depression
Age 18years - 65years
Clinical Study IdentifierTX4751
Last Modified on19 February 2024

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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