A Study to Evaluate Symptomatic Remission in Schizophrenia With Long Acting Risperidone Microspheres

Back to results

Primary Purpose

Status

Completed

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

risperidone

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, risperidone, Intramuscular injection, long-acting risperidone

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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)

Sites / Locations

Outcomes

Primary Outcome Measures

The symptomatic remission rate at 48 weeks

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00216528

First Posted

September 13, 2005

Last Updated

April 26, 2010

Sponsor

Janssen Korea, Ltd., Korea

1. Study Identification

Unique Protocol Identification Number

NCT00216528

Brief Title

A Study to Evaluate Symptomatic Remission in Schizophrenia With Long Acting Risperidone Microspheres

Official Title

A Prospective, Open-Label Study to Evaluate Symptomatic Remission in Schizophrenia With Long Acting Risperidone Microspheres (Risperdal Consta)

Study Type

Interventional

2. Study Status

Record Verification Date

April 2010

Overall Recruitment Status

Completed

Study Start Date

July 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

April 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Janssen Korea, Ltd., Korea

4. Oversight

5. Study Description

Brief Summary

The purpose of this study is to evaluate symptomatic remission rate in patients with schizophrenia using long acting risperidone microspheres

Detailed Description

Although most of Korean schizophrenic patients currently take oral antipsychotic medications, it is estimated that up to 75% of them have difficulty adhering to daily oral regimen. Long-acting injectable formulation may eliminate this need for daily medication. This is a prospective, open-label, multicenter study to determine the long-term efficacy, especially symptomatic remission rate of long-acting risperidone microspheres administrered in the muscle at 2 week intervals in patients with schizophrenia. The patients will receive intramuscular injections either 25, 37.5, 50 mg equivalent of risperidone at every 2 weeks for 1 year

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Schizophrenia

Keywords

Schizophrenia, risperidone, Intramuscular injection, long-acting risperidone

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

527 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

risperidone

Primary Outcome Measure Information:

Title

The symptomatic remission rate at 48 weeks

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Janssen Korea, Ltd. Clinical Trial

Organizational Affiliation

Janssen Korea, Ltd., Korea

Official's Role

Study Director

12. IPD Sharing Statement

Citations:

PubMed Identifier

24583566

Citation

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.

Results Reference

derived

Schizophrenia

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial