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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
Must not have
Female subjects who are pregnant or are breast feeding
Subject started a new non-medication treatment for schizophrenia or other psychiatric condition within the last 3 months prior to Screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not pregnant or breastfeeding.
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I started a new non-drug treatment for my mental health condition within the last 3 months.
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My PANSS score has dropped by more than 20% between two visits.
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I have previously been treated with NaBen®.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Mean change from baseline in Positive and Negative Syndrome Scale (PANSS) total score
Secondary study objectives
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 study objectives
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
430 Total Patients Enrolled
2 Trials studying Schizophrenia
340 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
~50 spots leftby Sep 2026
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