A Study of RO4917838 in Participants With Persistent, Predominant Negative Symptoms of Schizophrenia (NN25310)

Roche

Status and phase: Completed; Phase 3

Conditions: Schizophrenia

Treatments: Drug: Placebo; Drug: RO4917838; Drug: Antipshychotics (Standard of Care)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01192867

NN25310

2010-020370-42 (EudraCT Number)

Details and patient eligibility

About

This multi-center, randomized, double-blind, parallel-group, placebo-controlled study will evaluate the efficacy and safety of RO4917838 in participants with persistent, predominant negative symptoms of schizophrenia. Participants, on stable treatment with antipsychotics, will be randomized to receive daily oral doses of RO4917838 or matching placebo for 56 weeks (treatment period 1 of 24 weeks and treatment period 2 of 32 weeks), followed by an optional treatment extension for up to 3 years. After 52 weeks, participants who were originally randomized to an active treatment will be randomly assigned to receive either placebo or continue on the originally assigned study treatment for 4 weeks washout period (Week 52 to Week 56) for the assessment of potential withdrawal effects in a blinded manner using participants staying on active treatment as a control. Participants initially randomized to placebo will remain on placebo. After 56 weeks, participants who were switched to placebo in the washout period will return to their blinded, active treatment arm.

Enrollment: 629 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of schizophrenia of paranoid, disorganized, residual, undifferentiated or catatonic subtype
• Predominant negative symptoms
• With the exception of clozapine, participants are on any of the available marketed atypical or typical antipsychotics (treatment with a maximum of two antipsychotics)

Exclusion criteria

• Evidence that participant has clinically significant, uncontrolled and unstable disorder (e.g. cardiovascular, renal, hepatic disorder)
• Body Mass Index (BMI) of less than (<) 17 or greater than (>) 40 kilograms per meter square (kg/m^2)
• 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 Exrapyramidal Symptoms Rating Scale-Abbreviated (ESRS-A) (Clinical Global Impression, Parkinsonism)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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629 participants in 3 patient groups, including a placebo group

RO4917838 20 milligrams (mg)

Experimental group

Description:

Participants, on stable antipsychotics, will receive RO4917838 orally at 20 mg once daily (QD) up to 56 weeks followed by an optional treatment extension for up to 3 years.

Treatment:

Drug: RO4917838

Drug: Antipshychotics (Standard of Care)

RO4917838 10 mg

Experimental group

Description:

Participants, on stable antipsychotics, will receive RO4917838 orally at 10 mg QD up to 56 weeks followed by an optional treatment extension for up to 3 years.

Treatment:

Drug: RO4917838

Drug: Antipshychotics (Standard of Care)

Placebo

Placebo Comparator group

Description:

Participants, on stable antipsychotics, will receive RO4917838 matching placebo orally QD up to 56 weeks.

Treatment:

Drug: Antipshychotics (Standard of Care)

Drug: Placebo