Authorised Therapeutic confirmatory (Phase III) Schizophrenia

Evaluation of NBI-1117568 in Inpatient Adults with Schizophrenia

EU CTIS ID: 2025-521215-39-00

What this study is testing

To evaluate the efficacy of NBI-1117568 compared with placebo on improving behavioral and psychological symptoms of schizophrenia in adults

  • Therapeutic confirmatory (Phase III)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • ≥18 and ≤65 years of age.
  • Primary diagnosis of schizophrenia.
  • Experiencing a sudden worsening or relapse of symptoms starting <2 months before screening and currently warrants hospitalization.

You likely can't join if

  • Considered to be at imminent risk of suicide or injury to self or others.
  • Any unstable or poorly controlled medical condition or chronic disease.
  • Any laboratory test results indicating clinically significant, poorly managed, or unmanaged undiagnosed disease.
  • Certain heart conditions or uncontrolled blood pressure.
  • History of epilepsy, seizures (except seizures during childhood caused by a fever), or convulsions.
  • Currently taking medications that are not allowed.
See the full eligibility criteria
Who can join
  • ≥18 and ≤65 years of age.
  • Primary diagnosis of schizophrenia.
  • Experiencing a sudden worsening or relapse of symptoms starting <2 months before screening and currently warrants hospitalization.
What rules you out
  • Considered to be at imminent risk of suicide or injury to self or others.
  • Any unstable or poorly controlled medical condition or chronic disease.
  • Any laboratory test results indicating clinically significant, poorly managed, or unmanaged undiagnosed disease.
  • Certain heart conditions or uncontrolled blood pressure.
  • History of epilepsy, seizures (except seizures during childhood caused by a fever), or convulsions.
  • Currently taking medications that are not allowed.
  • Pregnant or breastfeeding.

The study team makes the final eligibility decision.

Where it's taking place

  • Serbia
  • United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Serbia; United States. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.