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Study Evaluating SCA-136 in Subjects With Acute Exacerbations of Schizophrenia

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
SCA-136 (200 mg)
SCA-136 (400 mg)
olanzapine (15 mg)
placebo
Sponsored by
Wyeth is now a wholly owned subsidiary of Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia

Eligibility Criteria

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

Inclusion Criteria: Clinical diagnosis of schizophrenia Ability to remain hospitalized for at least first 4 weeks of study Needs hospitalization due to worsening of schizophrenia Exclusion Criteria: Type 1 or 2 diabetes Previous use of clozapine Serious medical illness other than schizophrenia

Sites / Locations

Outcomes

Primary Outcome Measures

Change from baseline to day 42 on the positive subscale of the SCI-PANNS

Secondary Outcome Measures

Change from baseline to day 42 on:
SCI-PANNS total score
negative symptom sub-scale score of SCI-PANNS
general psychopathology subscale score of SCI-PANNS
response rate based upon SCI-PANNS total score
BPRS score
CGI-S score
CGI-I score
Cognitive assessments scores

Full Information

First Posted
December 12, 2005
Last Updated
December 7, 2007
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00265551
Brief Title
Study Evaluating SCA-136 in Subjects With Acute Exacerbations of Schizophrenia
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Olanzapine-Referenced, Parallel Group Safety, Efficacy, and Tolerability Study of SCA-136 in Subjects With Acute Exacerbations of Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to determine whether a low dose and a high dose of the study drug SCA-136 are effective and safe in the treatment of schizophrenia requiring hospitalization.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
300 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
SCA-136 (200 mg)
Intervention Type
Drug
Intervention Name(s)
SCA-136 (400 mg)
Intervention Type
Drug
Intervention Name(s)
olanzapine (15 mg)
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Change from baseline to day 42 on the positive subscale of the SCI-PANNS
Secondary Outcome Measure Information:
Title
Change from baseline to day 42 on:
Title
SCI-PANNS total score
Title
negative symptom sub-scale score of SCI-PANNS
Title
general psychopathology subscale score of SCI-PANNS
Title
response rate based upon SCI-PANNS total score
Title
BPRS score
Title
CGI-S score
Title
CGI-I score
Title
Cognitive assessments scores

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: Clinical diagnosis of schizophrenia Ability to remain hospitalized for at least first 4 weeks of study Needs hospitalization due to worsening of schizophrenia Exclusion Criteria: Type 1 or 2 diabetes Previous use of clozapine Serious medical illness other than schizophrenia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Wyeth is now a wholly owned subsidiary of Pfizer
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
Costa Mesa
State/Province
California
ZIP/Postal Code
92627
Country
United States
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
City
Paramount
State/Province
California
ZIP/Postal Code
90723
Country
United States
City
Pico Rivera
State/Province
California
ZIP/Postal Code
90660
Country
United States
City
Rosemead
State/Province
California
ZIP/Postal Code
91770
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
City
Middletown
State/Province
Connecticut
ZIP/Postal Code
06457
Country
United States
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20016
Country
United States
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33301
Country
United States
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60194
Country
United States
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46222
Country
United States
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70601
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21202
Country
United States
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63118
Country
United States
City
Willingboro
State/Province
New Jersey
ZIP/Postal Code
08046
Country
United States
City
Cedarhurst
State/Province
New York
ZIP/Postal Code
11516
Country
United States
City
Holliswood
State/Province
New York
ZIP/Postal Code
11423
Country
United States
City
Chagrin Falls
State/Province
Ohio
ZIP/Postal Code
44022
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
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
Fort Washington
State/Province
Pennsylvania
ZIP/Postal Code
19034
Country
United States
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38117
Country
United States
City
Austin
State/Province
Texas
ZIP/Postal Code
78729
Country
United States
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
City
DeSoto
State/Province
Texas
ZIP/Postal Code
75115
Country
United States
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98493
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24613032
Citation
Shen JH, Zhao Y, Rosenzweig-Lipson S, Popp D, Williams JB, Giller E, Detke MJ, Kane JM. A 6-week randomized, double-blind, placebo-controlled, comparator referenced trial of vabicaserin in acute schizophrenia. J Psychiatr Res. 2014 Jun;53:14-22. doi: 10.1016/j.jpsychires.2014.02.012. Epub 2014 Feb 24.
Results Reference
derived

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Study Evaluating SCA-136 in Subjects With Acute Exacerbations of Schizophrenia

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