Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00246259
Status:
COMPLETED
Last Update Posted:
2013-12-11
First Post:
2005-10-28
Brief Title:
A Trial Comparing Risperidone Long-Acting Injection With Oral Antipsychotic in the Treatment of Early Psychosis
Sponsor:
Janssen-Ortho Inc Canada
Organization:
Janssen-Ortho Inc Canada
Study Overview
Official Title:
An Open-Label Randomized Trial Comparing Risperdal Consta With Oral Antipsychotic Care in the Treatment of Early Psychosis
Status:
COMPLETED
Status Verified Date:
2013-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the effectiveness safety and tolerability of risperidone long-acting injection LAI versus oral antipsychotics in participants with recent onset psychosis abnormal thinking andor hallucinations
Detailed Description:
This is an open-label all people know identity of intervention randomized the study drug is assigned by chance multicenter conducted in more than 1 center and exploratory study in participants with schizophrenia psychiatric disorder with symptoms of emotional instability detachment from reality or schizoaffective disorder mixed psychiatric disorder relating to complex psychotic state that has features of both schizophrenia and mood disorder Duration of this study will be 24 months Study assessment visits will be conducted at Screening Baseline Week 2 every 4 weeks till Week 22 at Week 28 every 12 weeks till Week 88 and at Week 104 All eligible participants will receive either risperidone long acting injection 25 milligram mg intramuscularly into the muscle along with their current oral medication atypical antipsychotic - risperidone quetiapine olanzapine or only their current oral medication Efficacy will be evaluated primarily by Positive and Negative Syndromes Scale PANSS time to relapse and Social and Occupational Functioning Assessment Scale SOFAS Participantss safety will be evaluated throughout the study mainly by Abnormal Involuntary Movement Scale AIMS Barnes Akathisia Rating Scale BARS and Simpson Angus Scale SAS
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| RISSCH4056 | None | None | None |