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A Study of RO4917838 in Combination With Antipsychotic Treatment in Patients With Schizophrenia.

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
RO4917838
RO4917838
RO4917838
Placebo
Standard antipsychotic therapy
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 - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • adult patients, 18-60 years of age;
  • diagnosis of schizophrenia (based on screening tests);
  • outpatients, with no hospitalization for worsening of schizophrenia within 3 months;
  • medically and psychiatrically stable over prior 1 month and psychiatrically stable without symptom exacerbation within prior 3 months;
  • currently taking no more than 2 antipsychotic drugs.

Exclusion Criteria:

  • began a new non-medication treatment for schizophrenia or other psychiatric condition within last 3 months;
  • on >1 antidepressant, or a change in dose of antidepressant within 3 months;
  • alcohol or substance abuse or dependence within 3 months;
  • has previously received RO4917838.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Experimental

Arm Label

3

4

1

2

Arm Description

Outcomes

Primary Outcome Measures

Mean change from baseline in PANSS (Positive and Negative Syndrome Scale) negative factor score.

Secondary Outcome Measures

Change from baseline in total PANSS score, CGI, PSP, SGLS; cognition status changes.
AEs, laboratory parameters, C-SSRS

Full Information

First Posted
February 4, 2008
Last Updated
June 23, 2014
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT00616798
Brief Title
A Study of RO4917838 in Combination With Antipsychotic Treatment in Patients With Schizophrenia.
Official Title
Randomized, Double-blind, Placebo-controlled add-on Trial of the Safety and Efficacy of RO4917838 in Outpatients on Select Atypical Antipsychotics With Prominent Negative or Disorganized Thought Symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (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 study will determine the efficacy and safety of RO4917838 in patients with schizophrenia who are stable on current antipsychotic treatment (olanzapine, que tiapine, risperidone, paliperidone or aripiprazole) with prominent negative or d isorganized thought symptoms. After a 4 week run in period on their current anti psychotic treatment, patients will be randomized to receive placebo 10mg, 30mg, or 60mg of RO4917838 once daily, p.o., as add-on therapy. The anticipated time o n study treatment is <3 months, and the target sample size is 100-500 individual s.

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
323 (Actual)

8. Arms, Groups, and Interventions

Arm Title
3
Arm Type
Experimental
Arm Title
4
Arm Type
Placebo Comparator
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
RO4917838
Intervention Description
10mg po daily
Intervention Type
Drug
Intervention Name(s)
RO4917838
Intervention Description
30mg po daily
Intervention Type
Drug
Intervention Name(s)
RO4917838
Intervention Description
60mg po daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
po daily
Intervention Type
Drug
Intervention Name(s)
Standard antipsychotic therapy
Intervention Description
As prescribed
Primary Outcome Measure Information:
Title
Mean change from baseline in PANSS (Positive and Negative Syndrome Scale) negative factor score.
Time Frame
Week 8
Secondary Outcome Measure Information:
Title
Change from baseline in total PANSS score, CGI, PSP, SGLS; cognition status changes.
Time Frame
Throughout study
Title
AEs, laboratory parameters, C-SSRS
Time Frame
Throughout study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: adult patients, 18-60 years of age; diagnosis of schizophrenia (based on screening tests); outpatients, with no hospitalization for worsening of schizophrenia within 3 months; medically and psychiatrically stable over prior 1 month and psychiatrically stable without symptom exacerbation within prior 3 months; currently taking no more than 2 antipsychotic drugs. Exclusion Criteria: began a new non-medication treatment for schizophrenia or other psychiatric condition within last 3 months; on >1 antidepressant, or a change in dose of antidepressant within 3 months; alcohol or substance abuse or dependence within 3 months; has previously received RO4917838.
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
Granada Hills
State/Province
California
ZIP/Postal Code
91344
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60169
Country
United States
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19139
Country
United States
City
Austin
State/Province
Texas
ZIP/Postal Code
78754
Country
United States
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
City
De Soto
State/Province
Texas
ZIP/Postal Code
75115
Country
United States
City
Irving
State/Province
Texas
ZIP/Postal Code
75062
Country
United States
City
Wien
ZIP/Postal Code
1010
Country
Austria
City
Wien
ZIP/Postal Code
1090
Country
Austria
City
Curitiba
ZIP/Postal Code
80520-000
Country
Brazil
City
Pelotas
ZIP/Postal Code
96030-002
Country
Brazil
City
Rio de Janeiro
ZIP/Postal Code
21020-130
Country
Brazil
City
Salvador
ZIP/Postal Code
40301-500
Country
Brazil
City
Sao Paulo
ZIP/Postal Code
04044-000
Country
Brazil
City
Sao Paulo
ZIP/Postal Code
05403-010
Country
Brazil
City
Marseille
ZIP/Postal Code
13009
Country
France
City
Orvault
ZIP/Postal Code
44700
Country
France
City
Toulon
ZIP/Postal Code
83056
Country
France
City
Achim
ZIP/Postal Code
28832
Country
Germany
City
Bochum
ZIP/Postal Code
44805
Country
Germany
City
Freiburg
ZIP/Postal Code
79104
Country
Germany
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
City
Nürnberg
ZIP/Postal Code
90402
Country
Germany
City
Westerstede
ZIP/Postal Code
26655
Country
Germany
City
Balassagyarmat
ZIP/Postal Code
2660
Country
Hungary
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
City
Budapest
ZIP/Postal Code
1097
Country
Hungary
City
Budapest
ZIP/Postal Code
1125
Country
Hungary
City
Budapest
ZIP/Postal Code
1135
Country
Hungary
City
GYR
ZIP/Postal Code
9024
Country
Hungary
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
City
Nyíregyháza
ZIP/Postal Code
4400
Country
Hungary
City
Aichi
ZIP/Postal Code
470-1192
Country
Japan
City
Chiba
ZIP/Postal Code
272-8516
Country
Japan
City
Fukuoka
ZIP/Postal Code
807-8555
Country
Japan
City
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
City
Gunma
ZIP/Postal Code
373-0054
Country
Japan
City
Kanagawa
ZIP/Postal Code
232-0024
Country
Japan
City
Kanagawa
ZIP/Postal Code
236-0004
Country
Japan
City
Nagasaki
ZIP/Postal Code
852-8501
Country
Japan
City
Saga
ZIP/Postal Code
842-0192
Country
Japan
City
Sapporo
ZIP/Postal Code
060-8638
Country
Japan
City
Tokushima
ZIP/Postal Code
770-8503
Country
Japan
City
Tokyo
ZIP/Postal Code
162-8666
Country
Japan
City
Tokyo
ZIP/Postal Code
187-8551
Country
Japan
City
Mexico City
ZIP/Postal Code
06100
Country
Mexico
City
Mexico City
ZIP/Postal Code
11560
Country
Mexico
City
Mexico City
ZIP/Postal Code
1400
Country
Mexico
City
Mexico City
ZIP/Postal Code
14370
Country
Mexico
City
Monterrey
ZIP/Postal Code
64710
Country
Mexico
City
Bydgoszcz
ZIP/Postal Code
85-096
Country
Poland
City
Kielce
ZIP/Postal Code
25-317
Country
Poland
City
Skorzewo
ZIP/Postal Code
60-165
Country
Poland
City
Torun
ZIP/Postal Code
87-100
Country
Poland
City
Tuszyn
ZIP/Postal Code
95-080
Country
Poland
City
Zuromin
ZIP/Postal Code
09-300
Country
Poland
City
Kazan
ZIP/Postal Code
420012
Country
Russian Federation
City
Lipetsk
ZIP/Postal Code
399313
Country
Russian Federation
City
Moscow
ZIP/Postal Code
115522
Country
Russian Federation
City
Moscow
ZIP/Postal Code
117152
Country
Russian Federation
City
Moscow
ZIP/Postal Code
123367
Country
Russian Federation
City
Nizhny Novgorod
ZIP/Postal Code
603155
Country
Russian Federation
City
St Petersbourg
ZIP/Postal Code
190005
Country
Russian Federation
City
St Petersburg
ZIP/Postal Code
192019
Country
Russian Federation
City
St Petersburg
ZIP/Postal Code
193019
Country
Russian Federation
City
St. Petersburg
ZIP/Postal Code
193167
Country
Russian Federation

12. IPD Sharing Statement

Citations:
PubMed Identifier
24696094
Citation
Umbricht D, Alberati D, Martin-Facklam M, Borroni E, Youssef EA, Ostland M, Wallace TL, Knoflach F, Dorflinger E, Wettstein JG, Bausch A, Garibaldi G, Santarelli L. Effect of bitopertin, a glycine reuptake inhibitor, on negative symptoms of schizophrenia: a randomized, double-blind, proof-of-concept study. JAMA Psychiatry. 2014 Jun;71(6):637-46. doi: 10.1001/jamapsychiatry.2014.163.
Results Reference
derived

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A Study of RO4917838 in Combination With Antipsychotic Treatment in Patients With Schizophrenia.

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