A Study of RO4917838 (Bitopertin) in Patients With Acute Exacerbation of Schizophrenia

NCT01234779 | Completed Phase 2

• 2 other identifiers: WN253332010-021984-33
• Study Type: interventional
• Target: 301
• Locations: 5 countries
• Sites: 46

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.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (2)

• Change in Positive and Negative Syndrome Scale (PANSS) total score

  from baseline to Day 28

• Safety: Incidence adverse events

  8 weeks

Secondary Outcomes (6)

• Clinical response, defined as at least 30% or 50% improvement from baseline PANSS total score

  from baseline to Day 28

• Change in symptomatology as measured by the PANSS factor and subscale scores

  from baseline to Day 28

• Global improvement as measured by the Clinical Global Impressions-Severity (CGI-S) scale

  from baseline to Day 28

• Global improvement as measured by the Clinical Global Impressions-Change (CGI-C) rating scale

  from baseline to Day 28

• Observable behavioural change as determined by the Nurses' Observation Scale For Inpatient Evaluation (NOSIE)

  from baseline to Day 28

Study Arms (4)

A

EXPERIMENTAL

Drug: bitopertin [RO4917838]

B

EXPERIMENTAL

Drug: bitopertin [RO4917838]

C

ACTIVE COMPARATOR

Drug: olanzapine

D

PLACEBO COMPARATOR

Drug: placebo

Interventions

bitopertin [RO4917838] DRUG

10 mg orally daily, 4 weeks

A

olanzapine DRUG

15 mg orally daily, 4 weeks

C

placebo DRUG

orally daily, 4 weeks

D

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (46)

Unknown Facility

Little Rock, Arkansas, 72201, United States

Location

Unknown Facility

Cerritos, California, 90703, United States

Location

Unknown Facility

Oceanside, California, 92056, United States

Location

Unknown Facility

Pico Rivera, California, 90660, United States

Location

Unknown Facility

San Diego, California, 92121, United States

Location

Unknown Facility

Lauderhill, Florida, 33021, United States

Location

Unknown Facility

North Miami, Florida, 33161, United States

Location

Unknown Facility

Atlanta, Georgia, 30308, United States

Location

Unknown Facility

Lake Charles, Louisiana, 70601, United States

Location

Unknown Facility

Flowood, Mississippi, 39232, United States

Location

Unknown Facility

St Louis, Missouri, 63141, United States

Location

Unknown Facility

Willingboro, New Jersey, 08046, United States

Location

Unknown Facility

Holliswood, New York, 11423, United States

Location

Unknown Facility

New York, New York, 11004, United States

Location

Unknown Facility

Cincinnati, Ohio, 45219, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, 19139, United States

Location

Unknown Facility

Charlesston, South Carolina, 29405, United States

Location

Unknown Facility

Austin, Texas, 78754, United States

Location

Unknown Facility

Irving, Texas, 75062, United States

Location

Unknown Facility

Arad, 310022, Romania

Location

Unknown Facility

Bucharest, 010825, Romania

Location

Unknown Facility

Bucharest, 041902, Romania

Location

Unknown Facility

Bucharest, 041914, Romania

Location

Unknown Facility

Foscani, 620165, Romania

Location

Unknown Facility

Oradea, 410154, Romania

Location

Unknown Facility

Târgovişte, 130086, Romania

Location

Unknown Facility

Gatchina, 188357, Russia

Location

Unknown Facility

Moscow, 117152, Russia

Location

Unknown Facility

Petrozavodsk, 186131, Russia

Location

Unknown Facility

Saint Petersburg, 190005, Russia

Location

Unknown Facility

Saint Petersburg, 192019, Russia

Location

Unknown Facility

Saint Petersburg, 193167, Russia

Location

Unknown Facility

Saint Petersburg, 194044, Russia

Location

Unknown Facility

Saint Petersburg, 197341, Russia

Location

Unknown Facility

Talagi, 163530, Russia

Location

Unknown Facility

Bojnice, 972 01, Slovakia

Location

Unknown Facility

Bratislava, 826 06, Slovakia

Location

Unknown Facility

Liptovský Mikuláš, 3123, Slovakia

Location

Unknown Facility

Michalovce, 071 01, Slovakia

Location

Unknown Facility

Dnipropetrovsk, 49027, Ukraine

Location

Unknown Facility

Donetsk, 83008, Ukraine

Location

Unknown Facility

Kherson,Vil. Stepanivka, 73488, Ukraine

Location

Unknown Facility

Kyiv, 02660, Ukraine

Location

Unknown Facility

Kyiv, 04080, Ukraine

Location

Unknown Facility

Poltava, 36006, Ukraine

Location

Unknown Facility

Vinnytsia, 21005, Ukraine

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

(4-(3-fluoro-5-trifluoromethylpyridin-2-yl)piperazin-1-yl)(5-methanesulfonyl-2-(2,2,2-trifluoro-1-methylethoxy)phenyl)methanone; Olanzapine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2010
• First Posted: November 4, 2010
• Study Start: February 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

RU (9); RO (7); UA (7); SL (4); US (19)