A Study to Evaluate Symptomatic Remission in Schizophrenia With Long Acting Risperidone Microspheres
A Prospective, Open-Label Study to Evaluate Symptomatic Remission in Schizophrenia With Long Acting Risperidone Microspheres (Risperdal Consta)
1 other identifier
interventional
527
0 countries
N/A
Brief Summary
The purpose of this study is to evaluate symptomatic remission rate in patients with schizophrenia using long acting risperidone microspheres
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 schizophrenia
Started Jul 2005
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 22, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2007
CompletedApril 27, 2010
April 1, 2010
September 13, 2005
April 26, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The symptomatic remission rate at 48 weeks
Secondary Outcomes (1)
The change from baseline in Clinical Global Impression-Severity (CGI-S) score at 48 weeks; The change from baseline in SQLS score at 48 weeks; Health-Economic Data
Interventions
Eligibility Criteria
You may qualify if:
- Subjects with schizophrenia or schizoaffective disorder - Subjects who have experienced relapse or re-admission previously - Subject and/or his/her relative, guardian or legal representative who has signed the informed consent form
You may not qualify if:
- First antipsychotic treatment ever - On clozapine during the last 3 months - Serious unstable medical condition, including recent and present clinically relevant laboratory abnormalities - Subjects that are previously on concomitant use of Risperdal Consta within 60 days prior to entry - Previous sensitivity history to risperidone - History or current symptoms of tardive dyskinesia - History of neuroleptic malignant syndrome - Pregnant or breast-feeding female - Female patient of childbearing age without adequate contraception (adequate contraception includes: abstinence, oral contraceptive, intrauterine devices, barrier method (diaphragm or condom) plus spermicide - Norplant TM or Depo-Provera TM. A female patient of childbearing potential must have an adequate contraception and a negative urine pregnancy test at every visit)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Lee NY, Kim SH, Cho SJ, Chung YC, Jung IK, Kim CY, Kim DH, Lee DG, Lee YH, Lim WJ, Na YS, Shin SE, Woo JM, Yoon JS, Yoon BH, Ahn YM, Kim YS. A prospective, open-label study to evaluate symptomatic remission in schizophrenia with risperidone long-acting injectable in Korea. Int Clin Psychopharmacol. 2014 Sep;29(5):279-87. doi: 10.1097/YIC.0000000000000030.
PMID: 24583566DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Korea, Ltd. Clinical Trial
Janssen Korea, Ltd., Korea
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 22, 2005
Study Start
July 1, 2005
Study Completion
April 1, 2007
Last Updated
April 27, 2010
Record last verified: 2010-04