What is a clinical trial?

Clinical trials are carefully designed research studies that test the safety and effectiveness of new treatments and interventions in people. These studies rely on participation from volunteers, and are crucial for discovering new ways to prevent, diagnose, or treat specific health conditions – including mental health conditions.

person in doctor's coat talks to another person sitting next to them

Why do clinical trials matter?

Most of the medical treatments and cures we have today were developed through clinical trials. If you choose to be a part of a clinical trial, you can play a part in improving the future of mental health care.

What do mental health clinical trials test?

Clinical trials related to mental health test a variety of treatments and interventions, including:

  • Medication treatments – including new drugs or combinations of drugs, new ways to use existing medicines, and other substances that may be therapeutic, such as psychedelics or other compounds.
  • Therapies or behavioral interventions – including talk therapies, peer support programs, or other approaches to improve mental health through changing behaviors, thoughts, and/or feelings.
  • Digital tools and devices – including wearable devices, online platforms, mobile apps, artificial intelligence, or virtual reality programs, which may help to track mood, teach coping skills, or simulate mental health treatment settings.
  • Lifestyle changes – such as sleep improvement, exercise routines, and/or nutrition plans, and their potential impact on mental and physical health.
  • Other interventions – including new ways to prevent, treat, or screen for mental health conditions and more.

Every study adds to our understanding of mental health conditions and which treatments may help people feel and function better. If you are considering participating in a clinical trial, learn more here.

What are the phases of a clinical trial?

Every potential drug or treatment goes through several stages or “phases” of testing before it is available to the public. The first stages start small, and if things go well, the treatment is tested in larger groups with each phase. If the early phases of a trial show problems or safety issues, it may not progress beyond phase I or II.

Phase I purpose

Checks for safety and tries different levels or amounts of a potential treatment in a small group of volunteers.

Phase II purpose

Determines whether a treatment works for a specific condition and tracks different kinds of effects.

Phase III purpose

Confirms that the treatment works and monitors effects in a larger group. Compares the new treatment to existing ones (sometimes referred to as “treatment as usual” or TAU).

Phase IV purpose

Takes place after a treatment is approved and available to see how it works long-term when used in daily life.

If you or someone you know is struggling or in crisis, help is available. Call or text 988 or chat 988lifeline.org. You can also reach Crisis Text Line by texting HOME to 741741.


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