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Tests treatment safety and results for Refractory Schizophrenia
Official title 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 ID: NCT03094429
What this study is testing
What is NaBen®?
NaBen® is an investigational medicine, given as an once-daily, being studied as a potential treatment for refractory schizophrenia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is an adaptive, Phase II/III study in 2 parts (i.e. Part 1 (dose ranging) and Part 2 (Hypothesis testing)).
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55
You may be able to join if
- Male or female people who are between 18 and 55 years of age inclusive
- Subject is capable of providing informed consent and is willing to sign the ICF prior to study Screening and agrees to comply with the study protocol...
- If female and not infertile (defined below), the subject must agree for the duration of the study to use one of the following forms of contraception...
- The subject has Physician confirmed DSM-V diagnosis of schizophrenia for the past 2 years based on subject's recorded history and confirmed by...
- The people should have refractory schizophrenia as defined below (should meet at least two: either a and b; or a and c; or a and b and c):
You likely can't join if
- Meets the DSM-V criteria at Screening for intellectual disability, dissociative disorder, bipolar disorder, major depressive disorder...
- Initiation or dose change of lithium, antidepressant or other mood stabilizers within 16 weeks prior to Screening
- Initiation or dose change of benzodiazepines or sleep medications, or any other psychotropic medications due to worsening of schizophrenia symptoms...
- The subject has previously received NaBen®
- History of epilepsy, major head trauma, or any neurological illness other than Tourette's syndrome which might impair the subject's cognition or...
- History of allergic reaction to sodium benzoate
See the full eligibility criteria
Who can join
- Male or female people who are between 18 and 55 years of age inclusive
- Subject is capable of providing informed consent and is willing to sign the ICF prior to study Screening and agrees to comply with the study protocol requirements, or the subject has a Legally Authorized Representative...
- If female and not infertile (defined below), the subject must agree for the duration of the study to use one of the following forms of contraception 1) systemic hormonal treatment 2) an Intrauterine device (IUD) which...
- The subject has Physician confirmed DSM-V diagnosis of schizophrenia for the past 2 years based on subject's recorded history and confirmed by psychiatric evaluation and MINI International Neuropsychiatric Interview For...
- The people should have refractory schizophrenia as defined below (should meet at least two: either a and b; or a and c; or a and b and c):
- Prior non-response to at least 2 antipsychotic drugs of two different chemical classes for at least 4-6 weeks each at doses ≥ 400 mg equivalents of chlorpromazine or 4 mg/day risperidone, AND
- No period of good functioning in previous 2 years; OR,
- Moderate to severe psychopathology (total PANSS score equal or more than 70): including persistent psychotic symptoms, recurrent mood symptoms, repeated suicide attempts or suicidal ideation, uncontrolled aggressive...
- The subject has been receiving clozapine for a minimum of 6 months with the dose range of 200-900 mg/day. The dose should have remained unchanged for at least 3 months prior to Screening and not expected to change...
- The subject is outpatient, and has been consistently symptomatic without significant fluctuation per the Investigator, with no hospitalization for worsening of schizophrenia within 3 months of the Screening. If the...
- The subject has a minimum PANSS total score of 70 at the Screening and Baseline Visits (Visits 1 and 2)
- Without clinically significant abnormalities in physical exam, neurological exam and laboratory assessments (urine/blood routine, biochemical tests and ECG) which would exclude the subject from the study in the opinion...
- Body Mass Index (BMI) between 17 and 38 inclusive
- Subject has a negative routine urine illicit drug screening test (including heroin, amphetamines (including MDMA/ecstasy), cocaine, cannabis or PCP)
- The subject has a caregiver or some other identified responsible person (e.g., family member, social worker, caseworker, or nurse) as determined by the Investigator and per the local regulations. The identified...
- The subject must not be a danger to themselves or others per the Investigator's judgment
What rules you out
- Meets the DSM-V criteria at Screening for intellectual disability, dissociative disorder, bipolar disorder, major depressive disorder, schizoaffective disorder, schizophreniform disorder, autistic disorder, primary...
- Initiation or dose change of lithium, antidepressant or other mood stabilizers within 16 weeks prior to Screening
- Initiation or dose change of benzodiazepines or sleep medications, or any other psychotropic medications due to worsening of schizophrenia symptoms or medication side effects within four (4) weeks prior to Screening
- The subject has previously received NaBen®
- History of epilepsy, major head trauma, or any neurological illness other than Tourette's syndrome which might impair the subject's cognition or psychiatric functioning per the Investigator's judgment
- History of allergic reaction to sodium benzoate
- Serious medical illnesses such as end-stage renal disease, liver failure or heart failure that, in the opinion of the Investigator, may interfere with the conduct of the study
- Any significant gastrointestinal disorders that, in the opinion of the Investigator, markedly alter the absorption, metabolism or elimination of sodium benzoate
- Any movement disorders with a total score higher than 6 on SAS scale, or more than 2 on any items of the AIMS scale
- Current substance abuse, or history of meeting criteria for moderate or severe substance abuse (including alcohol, but excluding nicotine and caffeine) in the past six (6) months prior to Screening
- Female people who are pregnant (as confirmed by serum pregnancy test performed at Screening Visit) or are breast feeding
- History of cancer not in remission for the last three (3) years except for basal cell carcinoma and squamous cell carcinoma
- Participation in a clinical trial within 3 months prior to Screening or more than two clinical trials within 12 months
- Electroconvulsive Therapy (ECT) within 6 months prior to Screening
- The subject started a new non-medication treatment for schizophrenia or other psychiatric condition within the last 3 months prior to Screening (e.g. individual psychotherapy, cognitive behavioral therapy or...
- The subject's anti-EPS medications dose or regimen has changed within 2 weeks prior to Screening
- The subject's PANSS total score has decreased more than 20 percent using PANSS score evaluations at Visit 1 and Visit 2
The study team makes the final eligibility decision.
Where it's taking place
- Pasadena, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Pasadena, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.