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

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
bitopertin [RO4917838]
bitopertin [RO4917838]
olanzapine
placebo
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Placebo Comparator

Arm Label

A

B

C

D

Arm Description

Outcomes

Primary Outcome Measures

Change in Positive and Negative Syndrome Scale (PANSS) total score
Safety: Incidence adverse events

Secondary Outcome Measures

Clinical response, defined as at least 30% or 50% improvement from baseline PANSS total score
Change in symptomatology as measured by the PANSS factor and subscale scores
Global improvement as measured by the Clinical Global Impressions-Severity (CGI-S) scale
Global improvement as measured by the Clinical Global Impressions-Change (CGI-C) rating scale
Observable behavioural change as determined by the Nurses' Observation Scale For Inpatient Evaluation (NOSIE)
Time to readiness for discharge from inpatient unit as assessed by the Readiness For Hospital Discharge Questionnaire (RDQ)

Full Information

First Posted
November 3, 2010
Last Updated
November 1, 2016
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT01234779
Brief Title
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

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
301 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Title
B
Arm Type
Experimental
Arm Title
C
Arm Type
Active Comparator
Arm Title
D
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
bitopertin [RO4917838]
Intervention Description
10 mg orally daily, 4 weeks
Intervention Type
Drug
Intervention Name(s)
bitopertin [RO4917838]
Intervention Description
30 mg orally daily, 4 weeks
Intervention Type
Drug
Intervention Name(s)
olanzapine
Intervention Description
15 mg orally daily, 4 weeks
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
orally daily, 4 weeks
Primary Outcome Measure Information:
Title
Change in Positive and Negative Syndrome Scale (PANSS) total score
Time Frame
from baseline to Day 28
Title
Safety: Incidence adverse events
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Clinical response, defined as at least 30% or 50% improvement from baseline PANSS total score
Time Frame
from baseline to Day 28
Title
Change in symptomatology as measured by the PANSS factor and subscale scores
Time Frame
from baseline to Day 28
Title
Global improvement as measured by the Clinical Global Impressions-Severity (CGI-S) scale
Time Frame
from baseline to Day 28
Title
Global improvement as measured by the Clinical Global Impressions-Change (CGI-C) rating scale
Time Frame
from baseline to Day 28
Title
Observable behavioural change as determined by the Nurses' Observation Scale For Inpatient Evaluation (NOSIE)
Time Frame
from baseline to Day 28
Title
Time to readiness for discharge from inpatient unit as assessed by the Readiness For Hospital Discharge Questionnaire (RDQ)
Time Frame
from baseline to Day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72201
Country
United States
City
Cerritos
State/Province
California
ZIP/Postal Code
90703
Country
United States
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
City
Pico Rivera
State/Province
California
ZIP/Postal Code
90660
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92121
Country
United States
City
Lauderhill
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70601
Country
United States
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
City
Willingboro
State/Province
New Jersey
ZIP/Postal Code
08046
Country
United States
City
Holliswood
State/Province
New York
ZIP/Postal Code
11423
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
11004
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19139
Country
United States
City
Charlesston
State/Province
South Carolina
ZIP/Postal Code
29405
Country
United States
City
Austin
State/Province
Texas
ZIP/Postal Code
78754
Country
United States
City
Irving
State/Province
Texas
ZIP/Postal Code
75062
Country
United States
City
Arad
ZIP/Postal Code
310022
Country
Romania
City
Bucuresti
ZIP/Postal Code
010825
Country
Romania
City
Bucuresti
ZIP/Postal Code
041902
Country
Romania
City
Bucuresti
ZIP/Postal Code
041914
Country
Romania
City
Foscani
ZIP/Postal Code
620165
Country
Romania
City
Oradea
ZIP/Postal Code
410154
Country
Romania
City
Targoviste
ZIP/Postal Code
130086
Country
Romania
City
Gatchina
ZIP/Postal Code
188357
Country
Russian Federation
City
Moscow
ZIP/Postal Code
117152
Country
Russian Federation
City
Petrozavodsk
ZIP/Postal Code
186131
Country
Russian Federation
City
St Petersburg
ZIP/Postal Code
190005
Country
Russian Federation
City
St Petersburg
ZIP/Postal Code
193167
Country
Russian Federation
City
St Petersburg
ZIP/Postal Code
194044
Country
Russian Federation
City
St Petersburg
ZIP/Postal Code
197341
Country
Russian Federation
City
St. Petersburg
ZIP/Postal Code
192019
Country
Russian Federation
City
Talagi
ZIP/Postal Code
163530
Country
Russian Federation
City
Bojnice
ZIP/Postal Code
972 01
Country
Slovakia
City
Bratislava
ZIP/Postal Code
826 06
Country
Slovakia
City
Liptovsky Mikulas
ZIP/Postal Code
3123
Country
Slovakia
City
Michalovce
ZIP/Postal Code
071 01
Country
Slovakia
City
Dnipropetrovsk
ZIP/Postal Code
49027
Country
Ukraine
City
Donetsk
ZIP/Postal Code
83008
Country
Ukraine
City
Kherson,Vil. Stepanivka
ZIP/Postal Code
73488
Country
Ukraine
City
Kyiv
ZIP/Postal Code
02660
Country
Ukraine
City
Kyiv
ZIP/Postal Code
04080
Country
Ukraine
City
Poltava
ZIP/Postal Code
36006
Country
Ukraine
City
Vinnytsya
ZIP/Postal Code
21005
Country
Ukraine

12. IPD Sharing Statement

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

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