Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00061802
Status:
COMPLETED
Last Update Posted:
2012-02-07
First Post:
2003-06-04
Brief Title:
Efficacy and Safety of Two Atypical Antipsychotics vs Placebo in Patients With an Acute Exacerbation of Either Schizophrenia or Schizoaffective Disorder
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
A Randomized Double Blind Study to Evaluate the Efficacy and Safety of Two Atypical Antipsychotics vs Placebo in Patients With an Acute Exacerbation of Either Schizophrenia or Schizoaffective Disorder
Status:
COMPLETED
Status Verified Date:
2012-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A study to evaluate the efficacy and safety of two atypical antipsychotics vs placebo in patients with an acute exacerbation of either schizophrenia or schizoaffective disorder
Detailed Description:
This study was intended to compare the efficacy and safety of risperidone quetiapine and placebo in the treatment of patients with acute exacerbations of schizophrenia or schizoaffective disorder The primary tested hypothesis was a comparison of the efficacy of risperidone and quetiapine active combined group to placebo Other a priori hypotheses tested included comparison of the onset of antipsychotic effect of risperidone to quetiapine and placebo and to evaluate the efficacy safety and cost of risperidone compared with quetiapine in the treatment of subjects with an acute exacerbation of schizophrenia or schizoaffective disorder
During the first phase of the study 15 days patients randomized to risperidone were titrated from 1 mg to 4 mg or from 1 mg to 6 mg per day depending on body weight Patients randomized to quetiapine were titrated from 50 mg to 400 mg or from 50 mg to 600 mg per day depending on body weight Based on investigators determination of patient clinical response patients in the quetiapine group could be titrated to a maximum of 600 mg or 800 mg per day depending on body weight
During the second phase of the study days 15 - 42 patients continue to take the dose of study medication taken in the first phase but additional psychotropic medication could be added as clinically necessary to control symptoms in patients who remained sufficiently symptomatic defined as a certain minimum value on a clinical global severity scale
During the first phase of the study 15 days patients randomized to risperidone were titrated from 1 mg to 4 mg or from 1 mg to 6 mg per day depending on body weight Patients randomized to quetiapine were titrated from 50 mg to 400 mg or from 50 mg to 600 mg per day depending on body weight Based on investigators determination of patient clinical response patients in the quetiapine group could be titrated to a maximum of 600 mg or 800 mg per day depending on body weight
During the second phase of the study days 15 - 42 patients continue to take the dose of study medication taken in the first phase but additional psychotropic medication could be added as clinically necessary to control symptoms in patients who remained sufficiently symptomatic defined as a certain minimum value on a clinical global severity scale
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None