A Phase III, multi-center, randomized, 24 week, double-blind, parallel-group, placebocontrolled study to evaluate efficacy and safety of RO4917838 in stable patients with persistent, predominant negative symptoms of schizophrenia treated with antipsychotics followed by a 28 week, double-blind treatment period. - ND
- Conditions
- Treatment of negative symptoms for patients with schizophrenia treated with antipsychotics.MedDRA version: 9.1Level: LLTClassification code 10039626
- Registration Number
- EUCTR2010-020470-42-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
- 633
A patient may be included into Prospective Stabilization Period if the answer to all of the following statements is yes”: Demographic 1. Male and female patients, aged 18 and above. 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 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) ``doublebarrier`` contraception (condom, diaphragm and spermicide are each considered a 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 > 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 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 this study. Neuropsychiatric 6. Based on the screening 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 40 or greater on the sum of the 14 PANSS negative and disorganized thought factor items (items scored 1-7 for a maximum possible score of 98). 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
A patient will be excluded from Prospective Stabilization Period if the answer to any of the following statements is yes”. 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) that would increase the risk associated with taking study medication or would confound the interpretation of the 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), and 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 atrioventricular block, prolonged QTc (QTcF = 450 ms in males and = 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. Depressive symptoms, defined as a score of 9 or greater on the Calgary Depression Rating Scale for Schizophrenia (CDSS). 9. A score of 3 or greater on the global Parkinsonism item of the ESRS-A. 10. Based on the DSM-IV-TR criteria and screening SCID-CT have: o other current DSM-IV-TR Axis I diagnosis, such as but not limited to Major Depression, Bipolar, Obsessive Compulsive or Schizoaffective Disorders; o alcohol or substance dependence within 12 months or abuse within 3 months with the exception of nicotine;o dementia, delirium and other amnestic disorder per DSMIV- TR. 11. Diagnosis of mental retardation or severe organic brain syndromes. 12. In the investigator’s judgment, a significant risk of suicide or violent behavior. 13. A prior or current general medical condition that may be impairing cognition or other neuropsychiatric functioning (documented head trauma with a loss of consciousness > 1 hour or clear cognitive or behavioral sequelae, seizure disorder, stroke, neurodegenerative diseases, etc.). 14. Treated with electroconvulsive therapy (ECT) within the 5 months prior to the Prospective Stabilization Period. 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