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Safety, Tolerability, and Pharmacokinetics of Lumateperone Long-Acting Injectable Formulations in Patients With Schizophrenia or Schizoaffective Disorder

Examining safety and effects of Lumateperone injections for schizophrenia.

Recruiting
18-55 years
All
Phase 1

Study Purpose: This study looks at how safe and tolerable a new medicine called lumateperone is when given as a shot in the muscle to people with schizophrenia or schizoaffective disorder. It also checks how the body processes the medicine, known as pharmacokinetics (PK).

Who Can Join: Men and women ages 18 to 55 who have been stable with their schizophrenia or schizoaffective disorder for at least 3 months. Participants should not have any other major mental health issues and should be in good health according to the study doctors.

Study Details: This is a Phase 1b, open-label study, meaning both the doctors and patients know what treatment is being given. Participants will receive a single shot of lumateperone. The study will keep track of how they are doing to make sure the medicine is safe and works well.

  • Time Involved: One-time shot, plus follow-up visits for safety checks.
  • Compensation: Participants may receive payment for their time and travel.
  • Risks: Possible side effects include pain at injection site, feeling tired, or other symptoms. Safety checks will be conducted.
Study details
    Schizophrenia or Schizoaffective

NCT06627413

Intra-Cellular Therapies, Inc.

10 October 2024

Step 1 Get in touch with the nearest study center
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  • 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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