Schizophrenia MedDRA version: 8.1 Level: LLT Classification code 10039626 Term: Schizophrenia
Conditions
Interventions
Product Name: Org 25935
Product Code: Org 25935
Pharmaceutical Form: Tablet
Current Sponsor code: Org 25935
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 4-
Pharm
Sponsors
NV Organon
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. provide written informed consent after the scope and nature of the investigation, including recording of interviews for second opinion, have been explained to them before screening; 2. be between 18 and 55 years of age inclusive at screening; 3. be (if female) surgically sterile, post menopausal =1 year at screening, or when of childbearing potential, using one of the following contraceptive methods: - an intra uterine device (IUD); - hormonal contraceptives in combination with a barrier method; - a condom, used in combination with a spermicidal paste or prepared with such a paste; 4. be able to speak, read, understand, and possess the ability to respond to questions and follow simple instructions in a language in which the investigator is fluent and into which any required documents and instructions, including the informed consent, have been translated; 5. be diagnosed at the screening interview with non-first-episode schizophrenia meeting DSM-IV criteria; 6. be treated with an oral or intramuscular stable dose of one of the following second generation antipsychotics (SGAs): aripiprazole, olanzapine, quetiapine, risperidone, or ziprasidone; 7. be in the non-acute phase of their illness and clinically stable for the past 3 months at the time of screening, as demonstrated by: - treatment with the current SGA for at least 12 weeks prior to screening; - no dose change of the SGA or change in medication to treat clinical symptoms of schizophrenia in the past 4 weeks prior to screening; - no increase in level of psychiatric care due to worsening of symptoms of schizophrenia in the past 12 weeks prior to screening; - no jailing or imprisonment in the past 12 weeks prior to screening; 8. present a score = 4 on three or more of the following PANSS items (Marder factors for negative symptoms) at screening: blunted affect (N1), emotional withdrawal (N2), poor rapport (N3), passive social withdrawal (N4), lack of spontaneity (N6), motor retardation (G7), active social avoidance (G16); 9. present an overall PANSS negative subscale (Marder factors) score > 20; 10. be medically stable and receiving standard therapies at a stable dose in the past 4 weeks prior to screening for treatment of their medical condition if they have hypothyroidism, diabetes, high blood pressure or chronic respiratory conditions; 11. have a caregiver or an identified responsible person (e.g. family member, social worker or nurse) considered reliable by the investigator in providing support to the subject to ensure compliance with study treatment and protocol procedures. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 12. a primary psychiatric diagnosis other than schizophrenia per the allowed DSMIV criteria in the 30 days prior to screening; 13. a PANSS positive subscale score = 20 at screening; 14. more than ‘moderate’ severity (a score = 5) on two or more of the following PANSS positive symptom items at screening: delusions [P1], hallucinatory behavior [P3], excitement [P4], grandiosity [P5], suspiciousness/persecution [P6] 15. a score = 9 on the modified InterSePT Scale for Suicidal Thinking (ISST) at screening; 16. a score = 9 on the Calgary Depression Scale for Schizophrenia (CDSS) at screening; 17. a score = 3 on the clinical global impression of Parkinsonism of the abbreviated Extrapyramidal Symptom Rating Scale (ESRS-A) at screening; 18. untreated or uncompensated clinically significant renal, endocrine, hepatic, respiratory, cardiovascular, hematological, immunological or cerebrovascular disease, malignancy, or other chronic and/or degenerative process at screening; 19. a (history of) seizure disorder beyond childhood or when the subject is taking any anticonvulsants to prevent seizures; 20. a concurrent diagnosis of mental retardation or organic brain syndrome; 21. a clinically relevant visual disturbance, such as cataract, color blindness, macular degeneration, glaucoma, or retinal disease; 22. any clinically meaningful abnormal laboratory, vital sign, physical examination or ECG finding which, in the opinion of the investigator, may interfere with the interpretation of safety or efficacy evaluations; 23. a concurrent diagnosis of substance dependence other than nicotine or caffeine dependence in the past 6 months prior to screening; 24. a positive result on the urine alcohol/drug screen for alcohol or illicit drugs; 25. breast-feeding woman, or a positive result of urine pregnancy test (at screening), or plan to become pregnant during the course of the trial (females only); 26. treatment with high doses of benzodiazepines (> 4 mg per day lorazepam or equivalent); 27. an imminent risk of self-harm or harm to others; 28. treatment with clozapine in the past 6 months prior to screening; 29. treatment with lithium, valproate, lamotrigine, pregabalin, gabapentin, or carbamazepine in the past 12 weeks prior to screening; 30. exposure to an investigational drug within 6 months prior to screening; 31. non-compliance in the management of the disease in the past 12 weeks prior to screening; 32. treatment start, or dose change of an anticholinergic drug in the past 4 weeks prior to screening; 33. treatment start, or dose change of an (additional) antipsychotic, antidepressant, hypnotic or anxiolytic in the past 4 weeks prior to screening. 34. a blood potassium level 450 ms at screening; 35. no demonstrated benefit of antipsychotic treatment within the previous five years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate clinical and statistical superiority of Org 25935 over placebo on the amelioration of negative symptoms in subjects with schizophrenia who are concurrently treated with a stable dose of a second generation antipsychotic (SGA).;Secondary Objective: • To establish the safety and tolerability of oral doses up to and including 32 mg Org 25935 per day in subjects with schizophrenia who are concurrently treated with a stable dose of a SGA; • To evaluate the effects of Org 25935 on overall disease severity; • To evaluate the effects of Org 25935 on positive symptoms; • To evaluate the effects of Org 25935 on depressive symptoms; • To evaluate the effects of Org 25935 on cognitive functions; • To evaluate the effects of Org 25935 on neurological soft signs; • To evaluate the effects of Org 25935 on extrapyramidal symptoms; • To evaluate the effects of Org 25935 on level of functioning; • To collect population pharmacokinetic data; • To evaluate whether particular patient characteristics influence treatment efficacy or safety. ;Primary end point(s): The total score of the first 22 Items on SANS (Scale for the Assessment of Negative Symptoms). | — |
Countries
Austria, Czech Republic, Finland, France
Outcome results
None listed