Phase III, multi-center, randomized, 12-week, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of RO4917838 in patients with sub-optimally controlled symptoms of schizophrenia treated with antipsychotics followed by a 40-week double-blind, parallelgroup, placebo-controlled treatment period. - ND
- Conditions
- Adjunctive treatment of patients with sub-optimally controlled symptoms of schizophrenia. Sub-optimally controlled patients are defined as those who on their current medication have persistent symptoms of psychosis.MedDRA version: 9.1Level: LLTClassification code 10039626
- Registration Number
- EUCTR2010-020718-26-IT
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 600
Demographic 1. Male and female patients, ages 18 and above, inclusive; 2. Female patients who are not either surgically sterile (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 for the entire study duration to use one of the following forms of contraception: (1) systemic hormonal treatment (2) an IUD which was implanted at least 2 months prior to screening or (3) ``double-barrier`` contraception (condom, diaphragm and spermicide are each considered a barrier), or agree to remain sexually abstinent during the entire study period 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 or an identified responsible person (e.g., family member, social worker, case-worker, or nurse that spends > 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 input helpful for caregiver needs to be able and willing to attend study/clinic visits with the patients or to provide input via the phone. Neuropsychiatric 6. Based on the screening Structured Clinical Interview for DSMIV – 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 - Hallucinatory behavior, P6 - Suspiciousness, and G9 - Unusual thought content). 8. A score of = 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 =4. Et al...
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) yes
F.1.3.1 Number of subjects for this age range
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) < 18.5] or obesity [BMI > 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 < 50 beats per minute), atrial fibrillation, 2nd or 3rd degree AV block (AVB), prolonged QTc (QTcF = 450 ms in males or = 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. Has 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 = 600 mg/day chlorpromazine or = 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 <= 3 (mild or less) on all of the following items: P1 - Delusions, P2 - Conceptual disorganization, P3 - Hallucinatory behavior, G5 - Mannerisms/posturing, G9 - Unusual thought content, N1 - Blunted affect, N4 - Social withdrawal, N6 - 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 DSM-IVTR. 11. Diagnosis of mental retardation or severe organic brain syndromes. Et al...
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method