A Study of RO4917838 in Patients With Persistent, Predominant Negative Symptoms of Schizophrenia.
- Conditions
- Health Condition 1: null- Schizophrenia
- Registration Number
- CTRI/2012/07/002814
- Lead Sponsor
- HoffmannLa Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 630
A patient may be included into Prospective Stabilization Period if the answer to all of the following statements is â??yesâ??.
Demographic
1. Male and female patients, aged 18 and above.
2. Female patients who are not either surgically sterile (e.g., tuballigation 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 completion of the study medication: (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 (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 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).
8. A score of 22 or less on the sum of the 8 PANSS positive symptom factor items. The score of the items of P1 (delusions), P3 (hallucinatory behavior), P6 (suspiciousness) and G9 (unusual thought content) meet the following requirements:
o No more than 2 of the above items have a score of 4;
o All of the above items score less than 5.
9. Clinical stability for the 5 months prior to the Prospective
Stabilization Period as well as antipsychotic treatment stability for the past 8 weeks at the time of randomization, defined as:
o No significant changes in schizophrenia symptomatology;
o Antipsychotic treatment stability for at least 4 weeks prior to the Prospective Stabilization Period;
o No hospitalizations for the symptoms of schizophrenia during the past 5 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.
o No increase in level of psychiatric care (e.g., individual
psychotherapy, cognitive behavioral therapy, rehabilita
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) 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 less than 50 beats per minute), atrial fibrillation, 2nd or 3rd degree atrioventricular block, prolonged QTc (QTcF more than or equal to 450 ms in males and 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. Depressive symptoms, defined as a score of 9 or greater on the Calgary Depression Rating Scale for Schizophrenia (CDSS).
9. A severity score of 3 or greater on the Parkinsonism item of the ESRS-A (Clinical Global Impression, Parkinsonism).
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 investigatorâ??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 more than 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.
Medication
15. Participated in any investigational study or taken an
investigational drug within 90 days (or 5 times the half life of the investigational
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluate efficacy of 24 weeks treatment with RO4917838 in the PANSS negative symptom factor score in patients with persistent, predominant negative symptoms of schizophrenia treated with antipsychotics; <br/ ><br>Evaluate safety and tolerability of 24 weeks treatment with RO4917838 in patients with persistent, predominant negative symptoms of schizophrenia treated with antipsychotics. <br/ ><br>Timepoint: 24 weeks
- Secondary Outcome Measures
Name Time Method To evaluate efficacy of 24 weeks treatment with RO4917838 in personal and social functioning using PSP total score in patients with persistent, predominant negative symptoms of schizophrenia treated with antipsychotics.Timepoint: week 24