The primary objectives of the study are to:• 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.•…
ID
Source
Brief title
Condition
- Schizophrenia and other psychotic disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Efficacy (PANSS negative symptoms factor score)
2. Safety (incidence of adverse events)
Secondary outcome
Evaluate efficacy after 24 weeks of treatment with RO4917838 in patients with
persistent, predominant negative symptoms of schizophrenia treated with
antipsychotics:
• PANSS NSFS in the CFHR1-high subgroup
• personal and social functioning using PSP total score in the all-patient
population and in the CFHR1-high subgroup Additional objectives: evaluate the
effect of treatment with RO4917838 in patients with persistent, predominant
negative symptoms of schizophrenia, in the all-patient population and the CFHR1
subgroups according to patient*s CFHR1 serum at baseline with respect to:
• Other symptom domains of schizophrenia: PANSS total score; PANSS factors:
positive symptom, disorganized thought, hostility/excitement,
anxiety/depression; PANSS subscales: positive, negative and general
psychopathology at week 24; • Clinical Global Impression of severity and
improvement on overall and negative symptoms at week 24;
• Safety/tolerability of 52 weeks of randomized study treatment.
Background summary
Patients with negative symptoms represent a specific subset of patients with
schizophrenia. Among patients with schizophrenia, it is estimated that
approximately 20% have primary negative symptoms that are sufficiently
prominent to warrant clinical attention. Historically, the focus of research
into the neurobiology and pathophysiology of this illness has led to treatments
with efficacy primarily in positive symptoms. Therefore, there is an urgent
need for the development of more effective treatments for negative symptoms of
schizophrenia for use in patients treated with antipsychotic drugs.
Study objective
The primary objectives of the study are to:
• 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.
• Evaluate safety and tolerability of 24 weeks treatment with RO4917838 in
patients with persistent, predominant negative symptoms of schizophrenia
treated with antipsychotics.
Study design
Phase III, multi-center, randomized, 24 week, double-blind, parallel-group,
placebo-controlled study
Intervention
Treatment Period 1: 24 weeks:
- 5 mg of RO4917838 once a day
- 10 mg of RO4917838 once a day
- Matching placebo once a day
Treatment period 2: 32 weeks:
- 5 mg of RO4917838 once a day
- 10 mg of RO4917838 once a day
- Matching placebo once a day
- Patients assigned to either the 5 mg or 10 mg of RO4917838, may receive
placebo during the last 4 weeks of Treatment Period 2
Study burden and risks
RO4917838 treatment has been well tolerated in trials in patients with
schizophrenia and healthy volunteers in the dose range proposed. The risk for
the individual patient due to treatment with RO4917838 or study-related
procedures are considered minimal because of the proposed doses and the careful
monitoring of all critical safety parameters. The current risk/benefit profile
of the drug justifies continued assessment of RO4917838 in Phase III clinical
studies. There is an urgent need for the development of more effective
treatments for negative symptoms of schizophrenia for use in patients treated
with antipsychotic drugs.
Grenzacherstrasse 124
Basel CH-4070
CH
Grenzacherstrasse 124
Basel CH-4070
CH
Listed location countries
Age
Inclusion criteria
• Adult patients, aged 18 years and above
• Diagnosis of schizophrenia of paranoid, disorganized, residual,
undifferentiated or catatonic subtype
• Predominant negative symptoms
• With the exception of clozapine, patients are on any of the available marketed atypical or typical antipsychotics (treatment with a maximum of two antipsychotics);For all inclusion criteria, please see protocol.
Exclusion criteria
• Evidence that patient has clinically significant, uncontrolled and unstable disorder (e.g. cardiovascular, renal, hepatic disorder)
• Patient with body mass index (BMI) < 17 kg/m2 or > 40
kg/m2
• Depressive symptoms, defined as a score of 9 or greater on the Calgary Depression Rating Scale for Schizophrenia (CDSS)
• A severity score of 3 or greater on the Parkinsonism item of
the ESRS-A (Clinical Global Impression, Parkinsonism).
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2010-020467-21-NL |
| ClinicalTrials.gov | NCT01192906 |
| CCMO | NL40118.042.12 |