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NaBen Add-On Therapy for Schizophrenia

Phase 2 & 3
Recruiting
Research Sponsored by SyneuRx International (Taiwan) Corp
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
If female and not infertile, must agree to use specified forms of contraception
Subject has Physician confirmed DSM-V diagnosis of schizophrenia for the past 2 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights

Study Summary

This trial is testing a new drug, NaBen, to see if it's effective in treating residual symptoms of schizophrenia in adults. There are two parts to the trial, and the second part will test the optimal dose of NaBen determined in the first part. The trial will also assess the safety and tolerability of NaBen.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects aren't listed here, participants will be monitored for safety and tolerability of NaBen® in combination with clozapine. This includes watching out for any adverse reactions that may arise during the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I agree to use birth control as required if I can become pregnant.
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I have been diagnosed with schizophrenia for the last 2 years.
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I have steady symptoms without major changes.
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My recent health checks show no significant issues.
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My recent drug test for illegal substances was negative.
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My schizophrenia has not improved with treatment.
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I have been taking clozapine for at least 6 months.
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I am between 18 and 55 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean change from baseline in Positive and Negative Syndrome Scale (PANSS) total score
Secondary outcome measures
Percent change from baseline in Positive and Negative Syndrome Scale (PANSS) total score
Percent change in Clinical Global Impression-Severity (CGI-S) and -improvement (CGI-I)
Percent change in Hamilton Depression Rating Scale (HDRS)
+6 more
Other outcome measures
Assessment of suicidality per the Columbia-Suicide Severity Rating Scale (C-SSRS)
Changes and shifts in laboratory measurements-Biochemistry
Changes and shifts in laboratory measurements-Hematology
+11 more

Trial Design

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 Location

Who is running the clinical trial?

SyneuRx International (Taiwan) CorpLead Sponsor
3 Previous Clinical Trials
564 Total Patients Enrolled
2 Trials studying Schizophrenia
474 Patients Enrolled for Schizophrenia
Amarex Clinical ResearchOTHER
26 Previous Clinical Trials
1,395 Total Patients Enrolled

Media Library

Placebo (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03094429 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any participants in this research over the age of 50?

"The target age range for patients in this clinical trial is 18-55 years old."

Answered by AI

Are people still being recruited for this experiment?

"It is possible to enroll in this study currently, as it is still actively recruiting patients. The clinicaltrials.gov website states that the trial was originally posted on March 29th 2017 and last edited September 10th 2021."

Answered by AI

How many patients are included in this research project?

"That is correct. The clinical trial, which was first posted on March 29th 2017 and updated September 10th 2021, is currently recruiting patients. They are looking for a total of 287 individuals from 1 centre."

Answered by AI

Who might be a good candidate for this clinical trial?

"This trial is for people with schizophrenia who are between 18-55 years old. A total of 287 patients will be accepted into the study."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
An Adaptive Phase II/III, Two-Part, Double-Blind, Randomized, Placebo-controlled, Dose-Finding, Multi-center Study of the Safety and Efficacy of NaBen®, as an Add-on Therapy With Clozapine, for Residual Symptoms of Refractory Schizophrenia in Adults
2017. "An Adaptive Phase II/III, Two-Part, Double-Blind, Randomized, Placebo-controlled, Dose-Finding, Multi-center Study of the Safety and Efficacy of NaBen®, as an Add-on Therapy With Clozapine, for Residual Symptoms of Refractory Schizophrenia in Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03094429.
~73 spots leftby Sep 2026
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