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Zuranolone Pharmacokinetics (PK) and Safety Study Adolescent Participants With Major Depressive Disorder (MDD)

Study on Zuranolone's effects in teens with major depression.

Recruiting
12-17 years
Female
Phase 1

Zuranolone is a medicine that is being studied to see how it works in the body and if it is safe for teens with Major Depressive Disorder (MDD). MDD is a condition where someone feels very sad or hopeless for a long time. The study is for teens aged 12 to 17 who meet certain health criteria. For example, they need a certain score on a depression test and must weigh at least 20 kg (about 44 pounds). Girls who have started puberty can join, but they can't have other serious health issues like bipolar disorder or a history of substance abuse.

  • Participants will need to attend all scheduled study visits with a parent or caregiver.
  • The study monitors how the medicine moves in the body and checks for any side effects.
  • It excludes teens with certain health conditions or those at risk of harming themselves.
Study details
    Major Depressive Disorder

NCT05655507

Sage Therapeutics

8 July 2024

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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