A clinical study to determine safety, tolerability and initial efficacy of drug called NW-3509A which is taken orally, in patients with long standing schizophrenia getting inadequate benefit from their current antipsychotic medication.
- Conditions
- Health Condition 1: null- Schizophrenia
- Registration Number
- CTRI/2016/07/007092
- Lead Sponsor
- ewron Pharmaceuticals SpA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1. Age - 18 to 65 years, inclusive.
2. Sex â?? male, or female not of childbearing potential.
3. Body weight of at least 45 kg for females and 55 kg for males
4. Has a current diagnosis of schizophrenia in accordance with DSM-5. Other Axis-I disorders may be present only as lifetime diagnoses if they are not relevant to the current episode of schizophrenia.
5. Schizophrenia was diagnosed at least 2 years ago.
6. Has a total score on the PANSS <80.
7. Has a CGI-S rating of mildly, moderately or moderately severely ill (score of 3, 4 or 5).
8. Is in need of anti-psychotic treatment and is currently receiving a stable dose (minimally for 4 weeks prior to screening) of oral risperidone or aripiprazole (at least 2 mg risperidone dose-equivalent).
9. Current symptoms present for at least one month.
10. Patient is cooperative, able to take oral medication, willing to complete all aspects of the study, and capable of doing so.
11. Patient is residing at home or in a residential care facility with a caregiver available to ensure compliance with dosing and scheduled office visits.
12. Patient is able to understand the instructions and fully participate.
13. Patient has provided written informed consent prior to participating in the study.
14. Patient agrees to be hospitalized for up to 2 days at the start of dosing, and at each subsequent dose level increase, and when the investigator deems it necessary to ensure the safety of the patient.
1. DSM-5 diagnosis of schizophreniform disorder (295.40), schizoaffective disorder (295.70), or other primary psychiatric diagnosis, such as bipolar disorder or major depressive disorder (depression will be assessed at screening and baseline using the CDSS; a score of >=6 will be exclusionary)
2. History (within 3 months of study entry) or current diagnosis of Substance Use Disorder as defined by the DSM-5 criteria, with a severity of â??moderateâ?? or â??severeâ??, or patient is currently abusing drugs or alcohol or has done so in the past year. A history of nicotine dependence is acceptable
3. Severity of psychosis rated severe or higher (CGI-S of 6 or greater)
4. Has a rating of 5 (moderately severe) or higher on any of the following symptoms on the PANSS or has a rating of 4 (moderate) on more than two of these items.
5. History or current diagnosis of other psychiatric (Axis I diagnosis), or behavioral disorders that may interfere with the conduct or interpretation of the study
6. Known suicidal risk. A â??yesâ?? response on the C-SSRS Suicidal Ideation Item 4 or Item 5, or a â??yesâ?? response on any of the five C-SSRS Suicidal Behavior items, at screening, or a suicide attempt within the past 6 months, would exclude the patient from the study
7. â??Treatment resistantâ??, defined as lack of any significant symptomatic relief after adequate doses of two standard antipsychotic medications (from two different chemical classes, including at least one atypical antipsychotic) for 6 weeks of treatment each
8. History of neuroleptic malignant syndrome
9. Current evidence of moderate or severe tardive dyskinesia.
10. An advanced, severe, or unstable disease of any type that may interfere with any of the study evaluations, including any medical condition that could be expected to progress, recur, or change to such an extent that it may bias the assessment of the clinical or mental status of the patient to a significant degree or put the patient at special risk (e.g., liver or kidney disease; malignancy)
11. A disability that may prevent the subject from completing all study requirements (e.g., blindness, deafness, severe language difficulty)
12. A current diagnosis of active, uncontrolled peptic ulceration within the last year
13. A current diagnosis of acute, severe, or unstable asthmatic condition
14. Insulin-dependent diabetes mellitus. Patients with non-insulin-dependent diabetes will be eligible if the following criteria are satisfied
a. HbA1c < 7.0% at screening,
b. Diabetes is considered well controlled, with no changes in treatment regimen for at least 4 weeks prior to screening,
c. Diabetes is not newly diagnosed at screening;
15. History or current diagnosis of any neurodegenerative illness, dementia or significant concomitant neurological disease
16. History or current diagnosis of epilepsy or seizure disorder (other than febrile seizures in childhood)
17. Organic cerebral disease, cerebrovascular disease, focal neurological lesions or history of any trauma resulting in loss of consciousness (during the past 2 years)
18. Loss of 500 ml or more of blood during the 3-month period before the study, e.g. as a donor.
19. Prior surgery or current medical condition which might interfere with the absorption, distribution, metabolism or excretion of the study drug, e.g. gastric or
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the safety and tolerability of NW-3509A given as an oral dose range of 30 to 50 mg/day (15 to 25 mg, BID) in patients with schizophrenia on a stable dose of their current antipsychotic medication (aripiprazole or risperidone).Timepoint: 4 Weeks
- Secondary Outcome Measures
Name Time Method To evaluate the efficacy of the dose range of NW-3509A, compared to placebo, based on improvements in symptoms of schizophrenia, as assessed by the PANSS and CGI-C and CGI-S; â?¢ To determine the multiple-dose pharmacokinetics (PK) of NW-3509A at the doses tested, and determine if the PK parameters are dose proportional; â?¢ To determine the effect of NW-3509A, compared to placebo, on daily functioning, based on improvements on the Strauss-Carpenter Level of Functioning (LOF) scale.Timepoint: 4 Weeks