NBI-1117568 for Schizophrenia

Recruiting at 14 trial locations

Overseen By Neurocrine Medical Information Call Center

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Neurocrine Biosciences

Must not be taking: Antipsychotics

Disqualifiers: Unstable condition, Suicide risk, Substance use, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

210 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new medication called NBI-1117568 to see if it can help adults with schizophrenia who are experiencing a worsening of their symptoms. The study will check how well the medication works, how safe it is, and how well patients can tolerate it. The goal is to find an effective treatment for those whose condition is getting worse.

Will I have to stop taking my current medications?

Yes, if you are taking certain medications, including antipsychotics, you must stop them before joining the study.

What makes the drug NBI-1117568 unique for treating schizophrenia?

The research does not provide specific information about NBI-1117568, so its unique aspects compared to other schizophrenia treatments are not detailed. ^{1 2 3 4 5}

Research Team

Clinical Development Lead

Principal Investigator

Neurocrine Biosciences

Eligibility Criteria

Adults with schizophrenia who are currently experiencing a worsening of symptoms and need hospitalization can join. They must stop taking any disallowed medications, agree to stay in the hospital for the study, and follow all instructions. People using certain substances or with unstable health conditions, a risk of self-harm, or recent substance abuse issues cannot participate.

Inclusion Criteria

I am not taking any medications that are not allowed in the study.

I have been diagnosed with schizophrenia.

Completed informed consent

Exclusion Criteria

I do not have any unstable health conditions or other cancers.

I have always followed the rules in clinical studies.

Positive alcohol test or drug screen for disallowed substances

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either NBI-1117568 or placebo for 6 weeks

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• NBI-1117568
• Placebo

Trial Overview The trial is testing NBI-1117568's effectiveness and safety against a placebo in adults with schizophrenia during an acute episode. It's well-controlled: participants don't know if they're getting the real drug or placebo, nor do the researchers (double-blind).

Participant Groups

Group I: Dose Level D Experimental Treatment 1 Intervention

Participant administered Dose Level D (6 weeks)

Group II: Dose Level C Experimental Treatment 1 Intervention

Participant administered Dose Level C (6 weeks)

Group III: Dose Level B Experimental Treatment 1 Intervention

Participant administered Dose Level B (6 weeks)

Group IV: Dose Level A Experimental Treatment 1 Intervention

Participant administered Dose Level A (6 weeks)

Group V: Placebo Schedule Placebo Group 1 Intervention

Participant administered placebo (6 weeks)

Who Is Running the Clinical Trial?

Neurocrine Biosciences

Lead Sponsor

Trials

78

Recruited

6,600+

Kyle W. Gano

Neurocrine Biosciences

Chief Executive Officer since 2024

PhD in Pharmacology

Dr. Sanjay Keswani

Neurocrine Biosciences

Chief Medical Officer

MD

Findings from Research

The placebo effect in schizophrenia clinical trials is becoming a significant challenge, making it harder to detect the effectiveness of new treatments and increasing development costs.

Understanding the central nervous system mechanisms behind the placebo effect and improving study designs could help mitigate this issue and enhance the reliability of clinical trial results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Placebo-related effects in clinical trials in schizophrenia: what is driving this phenomenon and what can be done to minimize it? Alphs, L., Benedetti, F., Fleischhacker, WW., et al.[2021]

Placebo responses in clinical trials for schizophrenia are similar in magnitude and impact to those seen in major depression trials, and these responses have increased in recent years.

To address the challenge of high placebo responses in schizophrenia trials, a multipronged strategy is recommended, as no single factor has been identified as the primary cause.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Placebo response in clinical trials with schizophrenia patients. Kinon, BJ., Potts, AJ., Watson, SB.[2011]

In a meta-regression analysis of 18 double-blind, randomized, placebo-controlled trials involving 998 patients with stable schizophrenia, drugs were found to be more effective than placebo in reducing negative symptoms, although the effect size was small (Cohen's d: 0.208).

The study revealed a significant placebo response (Cohen's d: 2.909), indicating that factors like the number of trial arms, study sites, and industry sponsorship can influence the placebo effect, suggesting a need for improved trial designs to accurately assess treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of Placebo Response in Pharmacological Clinical Trials of Negative Symptoms in Schizophrenia: A Meta-regression Analysis. Fraguas, D., Díaz-Caneja, CM., Pina-Camacho, L., et al.[2022]

In a pooled analysis of two 6-week trials involving 422 patients with schizophrenia, early response to antipsychotic treatment (low-dose olanzapine or haloperidol) significantly distinguished active drug from placebo, with a greater mean reduction in psychiatric symptoms observed at 2 weeks.

The study suggests that shortening the duration of placebo-controlled trials from 6 weeks to 2-4 weeks is feasible for identifying efficacy in acutely ill patients, as early treatment response was predictive of overall treatment success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early onset of antipsychotic action in schizophrenia: evaluating the possibility of shorter acute efficacy trials. Kinon, BJ., Chen, L., Stauffer, VL., et al.[2021]

Placebo-controlled studies are essential for demonstrating the efficacy of treatments in schizophrenia, as they provide a clearer picture of responder rates compared to non-placebo-controlled studies.

The study found that responder rates in the treatment arms of non-placebo-controlled studies were similar to those in placebo arms, highlighting the variability in placebo responses and the need for standardized definitions of responders in future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Schizophrenia: do we really need placebo-controlled studies? Storosum, JG., Elferink, AJ., van Zwieten, BJ.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

Placebo-related effects in clinical trials in schizophrenia: what is driving this phenomenon and what can be done to minimize it? [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Placebo response in clinical trials with schizophrenia patients. [2011]

3. United States pubmed.ncbi.nlm.nih.gov

Predictors of Placebo Response in Pharmacological Clinical Trials of Negative Symptoms in Schizophrenia: A Meta-regression Analysis. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Early onset of antipsychotic action in schizophrenia: evaluating the possibility of shorter acute efficacy trials. [2021]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Schizophrenia: do we really need placebo-controlled studies? [2019]