287 Participants Needed

NaBen Add-On Therapy for Schizophrenia

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Overseen ByGuochuan Tsai
Age: 18 - 65
Sex: Any
Trial Phase: Phase 2 & 3
Sponsor: SyneuRx International (Taiwan) Corp
Must be taking: Clozapine
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

This is an adaptive, Phase II/III study in 2 parts (i.e. Part 1 (dose ranging) and Part 2 (Hypothesis testing)). NaBen® is granted Breakthrough Therapy Designation by US FDA as treatment for refractory schizophrenia. Part 1 Objectives: There are two primary objectives for Part 1 of this study: 1. To evaluate, in terms of dose-response, the effectiveness of NaBen® (1000 and 2000 mg/day) compared to Placebo (0 mg/day), when combined with clozapine, in improving the residual symptoms associated with refractory schizophrenia in adults, and; to determine the optimal dose to be used in Part 2 of this study. 2. Sample size re-assessment to evaluate the final sample size needed to proceed with Part 2 of the study The secondary objective of the Part 1 of this study is to evaluate the safety and tolerability of NaBen® (1000 and 2000 mg/day) compared to Placebo (0 mg/day), in combination with clozapine. Part 2 Objectives: The primary objective of the Part 2 of this study is to evaluate the effectiveness of NaBen® (at the optimal dose determined in the Part 1 of this study) compared to Placebo (0 mg/day), when combined with clozapine, in improving the residual symptoms associated with refractory schizophrenia in adults. The secondary objective of the Part 2 of this study is to evaluate the safety and tolerability of NaBen® (at the optimal dose determined in the Part 1 of this study) compared to Placebo (0 mg/day), in combination with clozapine.

Do I have to stop taking my current medications for the trial?

The trial requires participants to continue taking clozapine without changing the dose during the study. Other medications like lithium, antidepressants, mood stabilizers, benzodiazepines, or sleep medications should not have been started or had their doses changed recently. The protocol does not specify stopping other medications, but changes to certain medications close to the trial start may affect eligibility.

What data supports the idea that NaBen Add-On Therapy for Schizophrenia is an effective drug?

The available research shows that drugs, in general, have greater effectiveness than placebo in reducing negative symptoms in schizophrenia, although the effect size is small. This suggests that NaBen Add-On Therapy, as a drug, may also be effective in treating schizophrenia, but the data does not specifically highlight its effectiveness compared to other treatments.12345

What safety data is available for NaBen Add-On Therapy for Schizophrenia?

The provided research does not contain specific safety data for NaBen Add-On Therapy, Sodium Benzoate, or NaBen®. The studies focus on other antipsychotic drugs and placebo responses in schizophrenia trials, but do not mention NaBen or Sodium Benzoate. Therefore, no relevant safety data for NaBen is available in the given research.36789

Is the placebo a promising treatment for schizophrenia?

The placebo is not a promising treatment for schizophrenia. Studies show that actual drugs are more effective than placebos in reducing symptoms, even though placebos can sometimes show some effect. Overall, drugs have a greater impact on improving the condition.1231011

Eligibility Criteria

Adults aged 18-55 with refractory schizophrenia, who have not responded to at least two antipsychotic drugs and are on a stable dose of clozapine. Participants must be capable of consent or have a representative, agree to use contraception if applicable, and not have significant medical conditions or substance abuse issues.

Inclusion Criteria

I can give my consent or have someone legally allowed to do so for me.
I agree to use birth control as required if I can become pregnant.
I have been diagnosed with schizophrenia for the last 2 years.
See 9 more

Exclusion Criteria

I haven't started or changed the dose of any specified medications recently.
I have a history of certain medical conditions or allergies.
My only cancers in the last 3 years are skin cancers.
See 10 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
2 visits (in-person)

Treatment Part 1

Participants receive NaBen® (1000 or 2000 mg/day) or Placebo for dose-finding over 8 weeks

8 weeks
Weekly visits (in-person)

Interim Analysis

Data Safety and Monitoring Committee reviews data for safety and efficacy trends to determine optimal dose for Part 2

Not specified

Treatment Part 2

Participants receive NaBen® at the optimal dose or Placebo for hypothesis testing over 8 weeks

8 weeks
Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
2 visits (in-person)

Treatment Details

Interventions

  • NaBen®
  • Placebo
Trial Overview The study tests NaBen® as an add-on therapy with clozapine for adults with refractory schizophrenia. It's in two parts: first finding the best dose (1000 mg/day or 2000 mg/day) compared to placebo, then testing this optimal dose's effectiveness and safety.
Participant Groups
3Treatment groups
Active Control
Placebo Group
Group I: NaBen® - 2000 mg/dayActive Control1 Intervention
Two NaBen® ( 500 mg) will be taken twice daily at a total dose of 2000 mg/day during this study.
Group II: NaBen® - 1000 mg/dayActive Control1 Intervention
One NaBen® (500 mg) and one placebo will be taken twice daily at a total dose of 1000 mg/day during this study.
Group III: Placebo - 0 mg/dayPlacebo Group1 Intervention
The control treatment is placebo.

Find a Clinic Near You

Who Is Running the Clinical Trial?

SyneuRx International (Taiwan) Corp

Lead Sponsor

Trials
4
Recruited
720+

Amarex Clinical Research

Collaborator

Trials
28
Recruited
1,700+

Findings from Research

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.
Schizophrenia: do we really need placebo-controlled studies?Storosum, JG., Elferink, AJ., van Zwieten, BJ.[2019]
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.
Early onset of antipsychotic action in schizophrenia: evaluating the possibility of shorter acute efficacy trials.Kinon, BJ., Chen, L., Stauffer, VL., et al.[2021]
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.
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]

References

Schizophrenia: do we really need placebo-controlled studies? [2019]
Early onset of antipsychotic action in schizophrenia: evaluating the possibility of shorter acute efficacy trials. [2021]
Predictors of Placebo Response in Pharmacological Clinical Trials of Negative Symptoms in Schizophrenia: A Meta-regression Analysis. [2022]
Placebo response in clinical trials with schizophrenia patients. [2011]
Placebo effects in adult and adolescent patients with schizophrenia: combined analysis of nine RCTs. [2020]
Efficacy and Safety of Brexpiprazole for the Treatment of Acute Schizophrenia: A 6-Week Randomized, Double-Blind, Placebo-Controlled Trial. [2022]
Safety and Effectiveness of Blonanserin in Chinese Patients with Schizophrenia: An Interim Analysis of a 12-Week Open-Label Prospective Multi-Center Post-marketing Surveillance. [2022]
Safety and effectiveness of oral blonanserin for schizophrenia: A review of Japanese post-marketing surveillances. [2021]
The risk of death among adult participants in trials of antipsychotic drugs in schizophrenia. [2010]
Placebo-related effects in clinical trials in schizophrenia: what is driving this phenomenon and what can be done to minimize it? [2021]
11.United Statespubmed.ncbi.nlm.nih.gov
Control group bias in randomized atypical antipsychotic medication trials for schizophrenia. [2007]
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