Clinical trial NCT01234779: A Study of RO4917838 (Bitopertin) in Patients With Acute Exacerbation of Schizophrenia
Official title: A Phase II, Multi-center, Randomized, 4-week, Double-blind, Parallel Group, Placebo and Active-controlled Trial of the Safety and Efficacy of RO4917838 vs. Placebo in Patients With an Acute Exacerbation of Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Schizophrenia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-11-04
Enrollment: 301
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized, double-blind, placebo- and active-controlled, parallel group study will evaluate the safety and efficacy of RO4917838 (bitopertin) in patients with acute exacerbation of schizophrenia. Patients will be randomized to receive either RO4917838 10 mg or RO4917838 30 mg or olanzapine 15 mg or placebo orally daily for 4 weeks as inpatients, with a 4-week follow-up period.


Eligibility criteria: Inclusion Criteria:

* Adult patients, 18-65 years of age
* Diagnosis of schizophrenia (Diagnostic and Statistical Manual of Mental Disorders DSM IV-TR)
* Acute exacerbation which began within the prior 8 weeks
* Female patients must be surgically sterile or post-menopausal, or agree to use effective contraception for the duration of the study

Exclusion Criteria:

* Current psychiatric diagnosis other than schizophrenia
* Alcohol or substance dependence within 3 months or abuse within 1 month (except for nicotine)
* Electro-convulsive therapy (ECT) within the prior 6 months
* Previous treatment with RO4917838 or another GLYT inhibitor
* Current treatment with olanzapine, or previous treatment with intolerability or lack of response
* Treatment with long-acting injectable antipsychotic within 2 dosing intervals
* Treatment with \> 2 antipsychotics within 3 months
* History of neuroleptic malignant syndrome
* Have treatment-resistant schizophrenia as judged by treating physician or have failed two trials according to criteria in protocol

Primary outcomes:
measure: Change in Positive and Negative Syndrome Scale (PANSS) total score
timeFrame: from baseline to Day 28
measure: Safety: Incidence adverse events
timeFrame: 8 weeks
Secondary outcomes:
measure: Clinical response, defined as at least 30% or 50% improvement from baseline PANSS total score
timeFrame: from baseline to Day 28
measure: Change in symptomatology as measured by the PANSS factor and subscale scores
timeFrame: from baseline to Day 28
measure: Global improvement as measured by the Clinical Global Impressions-Severity (CGI-S) scale
timeFrame: from baseline to Day 28
measure: Global improvement as measured by the Clinical Global Impressions-Change (CGI-C) rating scale
timeFrame: from baseline to Day 28
measure: Observable behavioural change as determined by the Nurses' Observation Scale For Inpatient Evaluation (NOSIE)
timeFrame: from baseline to Day 28
measure: Time to readiness for discharge from inpatient unit as assessed by the Readiness For Hospital Discharge Questionnaire (RDQ)
timeFrame: from baseline to Day 28
Other outcomes:
Locations:
city: Little Rock
country: United States
state: Arkansas
city: Cerritos
country: United States
state: California
city: Oceanside
country: United States
state: California
city: Pico Rivera
country: United States
state: California
city: San Diego
country: United States
state: California
city: Lauderhill
country: United States
state: Florida
city: North Miami
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Lake Charles
country: United States
state: Louisiana
city: Flowood
country: United States
state: Mississippi
city: St. Louis
country: United States
state: Missouri
city: Willingboro
country: United States
state: New Jersey
city: Holliswood
country: United States
state: New York
city: New York
country: United States
state: New York
city: Cincinnati
country: United States
state: Ohio
city: Philadelphia
country: United States
state: Pennsylvania
city: Charlesston
country: United States
state: South Carolina
city: Austin
country: United States
state: Texas
city: Irving
country: United States
state: Texas
city: Arad
country: Romania
city: Bucuresti
country: Romania
city: Bucuresti
country: Romania
city: Bucuresti
country: Romania
city: Foscani
country: Romania
city: Oradea
country: Romania
city: Targoviste
country: Romania
city: Gatchina
country: Russian Federation
city: Moscow
country: Russian Federation
city: Petrozavodsk
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: Talagi
country: Russian Federation
city: Bojnice
country: Slovakia
city: Bratislava
country: Slovakia
city: Liptovsky Mikulas
country: Slovakia
city: Michalovce
country: Slovakia
city: Dnipropetrovsk
country: Ukraine
city: Donetsk
country: Ukraine
city: Kherson,Vil. Stepanivka
country: Ukraine
city: Kyiv
country: Ukraine
city: Kyiv
country: Ukraine
city: Poltava
country: Ukraine
city: Vinnytsya
country: Ukraine
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: