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NaBen® 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
The subject is outpatient with no hospitalization for worsening of schizophrenia within 3 months of the screening.If the subject is hospitalized during the study for worsening of schizophrenia symptoms the subject will be withdrawn from the study
Physician confirmed DSM-V diagnosis of schizophrenia for the past 2 years based on subject's history and confirmed by psychiatric evaluation and MINI International Neuropsychiatric Interview For Schizophrenia and Psychotic Disorders, version 7.0 (MINI, Version 7.0)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 64 weeks
Awards & highlights
Study Summary
This trial is designed to study the safety and efficacy of NaBen in improving symptoms of schizophrenia in adults. The trial will last for 52 weeks and will enroll subjects from multiple centers.
Who is the study for?
Adults aged 18-45 with schizophrenia, stable on current antipsychotic meds for at least 8 weeks, and in good physical health can join. They must not have been hospitalized for worsening symptoms within the last 3 months or have a history of substance abuse. Women must use contraception if not infertile.Check my eligibility
What is being tested?
The trial tests NaBen® as an add-on treatment to improve schizophrenia symptoms against a placebo. It's randomized and placebo-controlled, involving screening, run-in, double-blind treatment phases over several weeks, followed by a year-long open-label extension.See study design
What are the potential side effects?
While specific side effects are not listed here, participants will be monitored for any adverse reactions due to NaBen®, which could range from mild to severe depending on individual tolerance and reaction to the drug.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have not been hospitalized for my schizophrenia worsening in the last 3 months.
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I have been diagnosed with schizophrenia for the last 2 years.
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I haven't been hospitalized for worsening schizophrenia in the last 3 months.
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My schizophrenia is stable but I still have some symptoms.
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I am between 18 and 45 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 64 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~64 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
PANSS sub-scale scores and Marder PANSS factor scores
Other outcome measures
Abnormal Involuntary Movement Scale (AIMS)
Barnes Akathisia Rating Scale (BARS)
Clinical Global Impression-Severity (CGI-S) and -improvement (CGI-I)
+12 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: NaBen®Experimental Treatment1 Intervention
NaBen® is a oral tablet (500 mg), which will be taken twice daily at a total dose of 1000 mg/day during this study.
Group II: PlaceboPlacebo Group1 Intervention
The control treatment is placebo.
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Who is running the clinical trial?
SyneuRx International (Taiwan) CorpLead Sponsor
3 Previous Clinical Trials
503 Total Patients Enrolled
2 Trials studying Schizophrenia
413 Patients Enrolled for Schizophrenia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not been hospitalized for my schizophrenia worsening in the last 3 months.My condition did not improve after trying two different antipsychotics.I am currently taking or have taken clozapine.You have a history of epilepsy, significant head injury, or any other neurological condition (except Tourette's syndrome) that could affect your thinking or mental health, as determined by the doctor.My only cancers in the last 3 years are basal or squamous cell skin cancers.You have a serious stomach or digestive disorder that could affect how your body processes sodium benzoate.I am using reliable birth control or am infertile according to the study's definition.I have not had electroconvulsive therapy in the last 6 months.I have been diagnosed with schizophrenia for the last 2 years.I haven't started or changed doses of any mental health meds due to worsening schizophrenia or side effects in the last 4 weeks.I haven't been hospitalized for worsening schizophrenia in the last 3 months.My schizophrenia is stable but I still have some symptoms.My antipsychotic medication has been the same for at least 8 weeks and will not change during the study.I have previously taken NaBen®.I can and will sign the consent form and follow the study rules.I started a new non-medication treatment for a psychiatric condition within the last 3 months.I am not pregnant or breastfeeding.You have had an allergic reaction to sodium benzoate in the past.You have significant movement problems, with a score higher than 6 on the SAS scale or more than 2 on any items of the AIMS scale.I am between 18 and 45 years old.My medication for EPS has changed in the last 2 weeks.I haven't started or changed the dose of any mood-related medication in the last 16 weeks.Your body mass index (BMI) is between 17 and 35.
Research Study Groups:
This trial has the following groups:- Group 1: NaBen®
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any specific qualifications necessary to join this experiment?
"The schizophrenia clinical trial is looking for 348 participants that are aged 18-45."
Answered by AI
Are participants in this experiment required to be over 30 years old?
"The target age group for this clinical trial are individuals between 18-45 years old."
Answered by AI
Who else is applying?
What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
For additional information regarding investigative sites for this trial, contact SyneuRx International Corp.
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+
What questions have other patients asked about this trial?
How much will I get paid?
PatientReceived 2+ prior treatments
Why did patients apply to this trial?
I only receive a “disability” check once a month so I need more money.
PatientReceived 2+ prior treatments
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