Health Condition 1: null- patients with sub-optimally controlled symptoms of schizophrenia
Conditions
Interventions
Intervention1: RO4917838: 10 mg of RO4917838 p.o. q.d.
20 mg of RO4917838 p.o. q.d
Control Intervention1: Placebo: Matching placebo p.o. q.d
Sponsors
HoffmannLa Roche Ltd
Quintiles Research India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: A patient may be included in the Prospective Stabilization Period if the answer to all of the following statements is â??yesâ??. Demographic 1. Male and female patients, ages 18 and above, inclusive; 2. Female patients who are not either surgically sterile (e.g., tubal ligation or removal of ovaries or uterus) or post-menopausal (no spontaneous menstrual periods for at least one year confirmed by a negative hormone panel) must agree to use one of the following forms of contraception from screening until 90 days after the last dose of study medication: (1) systemic hormonal treatment (2) an intrauterine device (IUD) which was implanted at least 2 months prior to screening or (3) "doublebarrier" contraception (condom, diaphragm and spermicide are each considered a single barrier), or (4) agree to remain sexually abstinent during the entire study period (when contraception is not acceptable for cultural or religious beliefs). Procedural 3. Sign written informed consent after the scope and nature of the investigation have been explained to them before screening evaluations and willing to comply with the study restrictions. 4. Are fluent in the language of the investigator, study staff (including raters), and the informed consent. 5. Have a caregiver (e.g., family member, social worker, caseworker, or nurse that spends more than 4 hours/week with the patient) considered reliable by the investigator in providing support to the patient to ensure compliance with study treatment, assessment visits, and protocol procedures and who will be able to provide helpful input for completing study rating scales, i.e. PANSS and PSP. The caregiver needs to be able and willing to attend study/clinic visits with the patients or to provide input via the phone. The caregiver must provide written consent to participate in the study. Neuropsychiatric 6. Based on the screening Structured Clinical Interview for DSMIV â?? Clinical Trial (SCID-CT), a DSM-IV-TR diagnosis of schizophrenia, paranoid (295.30), disorganized (295.10), residual (295.60), undifferentiated (295.90) or catatonic subtype (295.20). 7. A score of 4 (moderate) or more on at least two of any of the following, PANSS items (P1 - Delusions, P3 â?? Hallucinatory behavior, P6 - Suspiciousness, and G9 - Unusual thought content). 8. A score of more than or equal to 70 in the PANSS total score, Appendix 4. 9. Are at least moderately ill as defined by severity of CGI-S of positive symptoms score more than or equal to 4. 10. Clinical stability for the 12 weeks (3 months) prior to the Prospective Stabilization Period and antipsychotic treatment stability for the past 8 weeks prior to the Prospective Stabilization Period which includes the screening period, defined as: a) No signs of exacerbation of schizophrenia symptomatology. b) Antipsychotic treatment stability for at least 8 weeks prior to the Prospective Stabilization Period (no change in antipsychotic dosing). c) No hospitalizations for the symptoms of schizophrenia during the past 3 months prior to the Prospective Stabilization Period. Documented hospitalization for social reasons for a maximum duration of 2 years and the patient has the opportunity to engage in social/functional activities, as required for PSP assessment, would be allowed. d) No incre
Exclusion criteria
Exclusion criteria: A patient will be excluded from Prospective Stabilization Period if the answer to any of the following statements is â??yesâ??. Medical Status 1. The patient has evidence of clinically significant, uncontrolled or unstable cardiovascular, renal, hepatic (incl. AST or ALT at or above 3x ULN, or bilirubin at or above 2x ULN), gastrointestinal, hematologic, immunological, neurological, endocrine, metabolic or pulmonary disease, anorexia [body mass index (BMI) less than 18.5] or obesity [BMI more than 40] (as determined by medical history, clinical laboratory or ECG results, or physical examination) or any other medical disorder that would increase the risk associated with taking study medication or would confound the interpretation of study results. 2. Hemoglobin less than 130 g/L (13 g/dL) in males or less than 120 g/L (12 g/dL) in females. 3. The patient has history of hemolytic anemia including hemoglobinopathies (e.g. thalassemia major, sickle-cell anemia), RBC membrane diseases (e.g. hereditary sphreocytosis), or G6PDH (glucose-6-phosphate dehydrogenase) deficiency or anemia of any cause. 4. Any clinically significant abnormal laboratory data, vital signs, physical examination at screening or baseline which in the opinion of the investigator, would interfere with safety assessments. 5. Clinically significant electrocardiogram (ECG) abnormality at screening, including sinus bradycardia (resting heart rate Less than 50 beats per minute), atrial fibrillation, 2nd or 3rd degree AV block (AVB), prolonged QTc (QTcF more than or equal to 450 ms in males or More than or equal to 470 ms in females) history of congenital long QT syndromes, or risk of Torsades de Pointes because of family history of sudden death, etc. 6. Positive result on the serum pregnancy test or are breast feeding at screening, or intend to become pregnant during the course of the trial. 7. History of neuroleptic malignant syndrome (NMS). Neuropsychiatric 8. Have treatment resistant schizophrenia as judged by the treating physician OR have failed two trials, meeting all of the following criteria: • 6 weeks duration of each trial; • two different classes of antipsychotics; • antipsychotic doses were more than or equal to 600 mg/day chlorpromazine or more than or equal to 6 mg/day risperidone equivalents; • No clinically significant response and absence of good social and occupational functioning in past 5 years . 9. Have met criteria for remission defined as: PANSS scores of less than or equal to 3 (mild or less) on all of the following items: P1 - Delusions, P2 - Conceptual disorganization, P3 â?? Hallucinatory behavior, G5 - Mannerisms/posturing, G9 - Unusual thought content, N1 - Blunted affect, N4 - Social withdrawal, N6 â?? Lack of spontaneity at screening. 10. Based on the DSM-IV-TR criteria and screening SCID-CT has: • other current DSM-IV-TR Axis I diagnosis, such as but not limited to major depression, bipolar, obsessive compulsive or schizoaffective disorders; • alcohol or substance dependence within 12 months or abuse within 3 months with the exception of nicotine; • dementia, delirium and other amnestic disorder per DSMIV- TR. 11. Diagnosis of mental retardation or severe organic brain syndromes. 12. In the investigatorâ??s judgment, a significan
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Positive symptoms factor score assessed by Positive and Negative Syndrome Scale (PANSS) [ Time Frame: Change from baseline to Week 12 ] Safety (incidence of adverse events) [ Time Frame: Week 12]Timepoint: week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease improvement on Clinical Global Impression - Improvement (CGI-I) symptoms scaleTimepoint: Change from baseline to Week 12;Disease severity on Clinical Global Impression - Severity (CGI-S) symptoms scaleTimepoint: Change from baseline to Week 12;Safety (incidence of adverse events)Timepoint: Week 52;Symptom domains of schizophrenia using Positive and Negative Syndrome Scale (PANSS)Timepoint: Change from baseline to Week 12 | — |
Countries
Argentina, Australia, Finland, France, Hungary, India, Mexico, Republic of Korea, Romania, Russian Federation, Sweden, United Kingdom, United States of America
Contacts
Public ContactSuchela Srivatsa
Quintiles Research India Pvt. Ltd
Outcome results
None listed