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Study Of Talnetant Versus Placebo And Risperidone In Schizophrenia

Primary Purpose

Schizophrenia

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

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring paranoid, catatonic, undifferentiated types, disorganized

Eligibility Criteria

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

Inclusion criteria: Subjects must have schizophrenia which is not secondary to another medical condition or substance abuse. Require inpatient hospitalization. Woman may enroll only if they are not of child-bearing potential OR are on a protocol-approved birth control method. Exclusion criteria: Subject is in their first episode of schizophrenia. Subject has other psychotic disorders or bipolar disorder. Subject has schizophrenia symptoms from taking another medicine or drug of abuse, or due to a general medical condition. Subject has a recent history of substance dependence/dependence, or tests positive for illicit drug. Subject has an unstable medical disorder, or any significant medical disorder including autistic disorder, organic brain disease, liver dysfunction, epilepsy or seizures, or is at increased risk of developing cerebrovascular problems like stroke. Subject has any significant abnormalities in any of the screening tests (ECGs, labs, physical examinations, etc.). Subject poses a current serious suicidal or homicidal risk. Subject has a positive pregnancy test, or is lactating or planning to become pregnant within one month of the study. Subject has recently or is currently participating in another clinical study. Subject is stabilized on their current schizophrenia treatment. Subject needs to take any of the medicines not permitted in the study, or has recently had ECT (electroconvulsive therapy) or TMS (transcranial magnetic stimulation). Subject was non-responsive to two or more adequate trials of antipsychotic treatments over the past 2 years. Subject has had an allergic or significant reaction to any of the study drugs, or can't take risperidone.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

talnetant

placebo

risperidone

Arm Description

200mg, 400mg, 600mg) twice a day

placebo

3mg twice a day

Outcomes

Primary Outcome Measures

The primary outcome measure is change in the Positive and Negative Syndrome Scale (PANSS) at Week 6 compared to baseline values.

Secondary Outcome Measures

The secondary measures assess both efficacy (cognition, depression) as well as a variety of safety/tolerability endpoints (adverse events, motor function, laboratory measures).

Full Information

First Posted
February 14, 2005
Last Updated
April 27, 2015
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00103727
Brief Title
Study Of Talnetant Versus Placebo And Risperidone In Schizophrenia
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
April 2015
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
October 2005 (Actual)
Study Completion Date
October 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

Brief Summary
This study will evaluate whether talnetant (200mg, 400mg, 600mg) twice a day is effective compared to placebo and risperidone 1-3mg twice a day in treating the positive and negative symptoms of schizophrenia. Study subjects will be treated with study drug for up to 6 weeks and will then return for a follow-up visit 2 weeks later. About 275 patients with schizophrenia will be enrolled in this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
paranoid, catatonic, undifferentiated types, disorganized

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
talnetant
Arm Type
Experimental
Arm Description
200mg, 400mg, 600mg) twice a day
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo
Arm Title
risperidone
Arm Type
Active Comparator
Arm Description
3mg twice a day
Intervention Type
Drug
Intervention Name(s)
Talnetant
Intervention Description
talnetant
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
risperidone
Intervention Description
Active Comparator
Primary Outcome Measure Information:
Title
The primary outcome measure is change in the Positive and Negative Syndrome Scale (PANSS) at Week 6 compared to baseline values.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
The secondary measures assess both efficacy (cognition, depression) as well as a variety of safety/tolerability endpoints (adverse events, motor function, laboratory measures).
Time Frame
6 weeks

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: Subjects must have schizophrenia which is not secondary to another medical condition or substance abuse. Require inpatient hospitalization. Woman may enroll only if they are not of child-bearing potential OR are on a protocol-approved birth control method. Exclusion criteria: Subject is in their first episode of schizophrenia. Subject has other psychotic disorders or bipolar disorder. Subject has schizophrenia symptoms from taking another medicine or drug of abuse, or due to a general medical condition. Subject has a recent history of substance dependence/dependence, or tests positive for illicit drug. Subject has an unstable medical disorder, or any significant medical disorder including autistic disorder, organic brain disease, liver dysfunction, epilepsy or seizures, or is at increased risk of developing cerebrovascular problems like stroke. Subject has any significant abnormalities in any of the screening tests (ECGs, labs, physical examinations, etc.). Subject poses a current serious suicidal or homicidal risk. Subject has a positive pregnancy test, or is lactating or planning to become pregnant within one month of the study. Subject has recently or is currently participating in another clinical study. Subject is stabilized on their current schizophrenia treatment. Subject needs to take any of the medicines not permitted in the study, or has recently had ECT (electroconvulsive therapy) or TMS (transcranial magnetic stimulation). Subject was non-responsive to two or more adequate trials of antipsychotic treatments over the past 2 years. Subject has had an allergic or significant reaction to any of the study drugs, or can't take risperidone.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72201
Country
United States
Facility Name
GSK Investigational Site
City
Anaheim
State/Province
California
ZIP/Postal Code
92805
Country
United States
Facility Name
GSK Investigational Site
City
Cerritos
State/Province
California
ZIP/Postal Code
90703
Country
United States
Facility Name
GSK Investigational Site
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Facility Name
GSK Investigational Site
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Facility Name
GSK Investigational Site
City
National City
State/Province
California
ZIP/Postal Code
91950
Country
United States
Facility Name
GSK Investigational Site
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
GSK Investigational Site
City
Pico Rivera
State/Province
California
ZIP/Postal Code
90660
Country
United States
Facility Name
GSK Investigational Site
City
Rosemead
State/Province
California
ZIP/Postal Code
91770
Country
United States
Facility Name
GSK Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
GSK Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92126
Country
United States
Facility Name
GSK Investigational Site
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
GSK Investigational Site
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20016
Country
United States
Facility Name
GSK Investigational Site
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
GSK Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
GSK Investigational Site
City
Oak Brook
State/Province
Illinois
ZIP/Postal Code
60523
Country
United States
Facility Name
GSK Investigational Site
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63118
Country
United States
Facility Name
GSK Investigational Site
City
Clementon
State/Province
New Jersey
ZIP/Postal Code
08021
Country
United States
Facility Name
GSK Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19131
Country
United States
Facility Name
GSK Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
GSK Investigational Site
City
Irving
State/Province
Texas
ZIP/Postal Code
75062
Country
United States
Facility Name
GSK Investigational Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States

12. IPD Sharing Statement

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Study Of Talnetant Versus Placebo And Risperidone In Schizophrenia

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