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A Study of the Efficacy and Safety of SP-624 in the Treatment of Adults With Major Depressive Disorder

Testing SP-624's effectiveness and safety for depression in adults.

Recruiting
18-65 years
All
Phase 2

This study tests how well a new drug, SP-624, works for adults with Major Depressive Disorder (MDD) compared to a dummy pill called a placebo. MDD is a condition that makes people feel very sad, empty, or irritable for a long time. The study is in Phase 2B, meaning it's checking both how safe and effective the drug is. Participants must be between 18 and 65 years old, have moderate to severe MDD, and be generally healthy. Some people cannot join, like those with certain heart problems or women who are pregnant. The study uses the DSM-5, a book that doctors use to identify mental disorders, to confirm MDD. A special interview called the MINI helps with this diagnosis. Your body mass index (BMI), a measure of body fat using height and weight, must be between 18 and 45 kg/m².

  • The study lasts several weeks, with multiple visits to the clinic.
  • Participants will receive compensation for their time and travel.
  • Potential risks include side effects from the drug.
Study details
    Major Depressive Disorder

NCT06254612

Sirtsei Pharmaceuticals, Inc.

26 April 2025

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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Learn more about clinical trials

What is a clinical trial?

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

Why should I take part in a clinical trial?

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

How long does a clinical trial take place?

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

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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