CTRI/2016/07/007092
Recruiting
Phase 2
A Phase IIa, prospective, randomized, double-blind, placebo-controlled, multiple-dose study designed to determine the safety, tolerability and preliminary efficacy of an oral dose range of NW-3509A in patients with chronic schizophrenia not responding adequately to their current antipsychotic medication.
ewron Pharmaceuticals SpA0 sites0 target enrollmentTBD
ConditionsHealth Condition 1: null- Schizophrenia
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- Schizophrenia
- Sponsor
- ewron Pharmaceuticals SpA
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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)
Outcomes
Primary Outcomes
Not specified
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