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Schizophrenia Study In Adults

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
talnetant
risperidone
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Talnetant, schizophrenia, NK3 receptor antagonist, psychosis

Eligibility Criteria

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

Inclusion Criteria: Patient must meet diagnostic criteria for schizophrenia. Exclusion Criteria: Patients with other psychotic disorders. Patients whose condition is due to the direct physiological effects of a substances (e.g., drug abuse) or a general medical condition. Patients with a history of autistic disorder or another pervasive developmental disorder. Patients with epilepsy or a history of seizures requiring treatment. Patients who are excluded from taking the drug risperidone. Patients who pose a current serious suicidal or homicidal risk. Patients who are adequately stabilized on their treatment.

Sites / Locations

  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center

Outcomes

Primary Outcome Measures

Change from baseline in the PANSS total score.

Secondary Outcome Measures

Secondary measures assessed efficacy, safety & tolerability endpoints using the PANSS, BPRS Psychosis score, CGI-S, CGI-GI, Calgary Depression Scale for Schizophrenia, Brief Assessment of Cognition for Schizophrenia, and others.

Full Information

First Posted
November 15, 2002
Last Updated
August 14, 2017
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00049946
Brief Title
Schizophrenia Study In Adults
Official Title
A Multicenter, Double-Blind, Double-Dummy, Placebo-Controlled, Randomized, Parallel Group Evaluation of the Efficacy and Safety of a Fixed-Dose of Talnetant Versus Placebo Versus Risperidone in Subjects With Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
April 2003 (Actual)
Study Completion Date
April 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

Brief Summary
A Placebo Controlled Study For Patients With Schizophrenia

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Talnetant, schizophrenia, NK3 receptor antagonist, psychosis

7. Study Design

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

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
talnetant
Intervention Type
Drug
Intervention Name(s)
risperidone
Primary Outcome Measure Information:
Title
Change from baseline in the PANSS total score.
Secondary Outcome Measure Information:
Title
Secondary measures assessed efficacy, safety & tolerability endpoints using the PANSS, BPRS Psychosis score, CGI-S, CGI-GI, Calgary Depression Scale for Schizophrenia, Brief Assessment of Cognition for Schizophrenia, and others.

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: Patient must meet diagnostic criteria for schizophrenia. Exclusion Criteria: Patients with other psychotic disorders. Patients whose condition is due to the direct physiological effects of a substances (e.g., drug abuse) or a general medical condition. Patients with a history of autistic disorder or another pervasive developmental disorder. Patients with epilepsy or a history of seizures requiring treatment. Patients who are excluded from taking the drug risperidone. Patients who pose a current serious suicidal or homicidal risk. Patients who are adequately stabilized on their treatment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials, MD
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Clinical Trial Call Center
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Cerritos
State/Province
California
ZIP/Postal Code
90703
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Chula Vista
State/Province
California
ZIP/Postal Code
91910
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Pico Rivera
State/Province
California
ZIP/Postal Code
90660
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Rosemead
State/Province
California
ZIP/Postal Code
91770
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95823
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
San Diego
State/Province
California
ZIP/Postal Code
92126
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
New Britain
State/Province
Connecticut
ZIP/Postal Code
06050
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Washington, D.C.
State/Province
District of Columbia
ZIP/Postal Code
20016
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60194
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Greenwood
State/Province
Indiana
ZIP/Postal Code
46143
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Clementon
State/Province
New Jersey
ZIP/Postal Code
08021
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Hollis
State/Province
New York
ZIP/Postal Code
11423
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Butner
State/Province
North Carolina
ZIP/Postal Code
27509
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27603
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73069
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78729
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Terrell
State/Province
Texas
ZIP/Postal Code
75160
Country
United States

12. IPD Sharing Statement

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Schizophrenia Study In Adults

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