MedTrace Logo

A Follow-Up Study of Schizophrenic Participants Following Treatment Discontinuation After Remission From a First Psychotic Episode

NCT00378092 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2014-05-08

No results posted yet for this study

Summary

The purpose of this study is to evaluate the outcome of medication discontinuation, the safety and effectiveness of re-initiating risperidone long acting injection (RLAI) in case of relapse (the return of a medical problem) of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) during the study observation period of 36 months.

Conditions

Interventions

DRUG

Oral risperidone

Oral risperidone 1 mg or 2 mg or 3 mg will be administered for 21 days from the first dose of RLAI (until RLAI injection becomes effective) and then taper off over the next 5 days. Thereafter, oral risperidone can be administered at the discretion of the Investigator if additional antipsychotic medication will be required due to acute exacerbation of symptoms between visits.

DRUG

Risperidone Long-Acting Injection (RLAI)

RLAI 25 mg to 50 mg will be administered, intramuscularly which will be tapered and discontinued over a period of up to 6 weeks.

DRUG

Risperidone Long-Acting Injection (RLAI)

Participants who will experience a disease relapse, will receive RLAI 25 mg, 37.5 mg, or 50 mg, every 2 weeks as an intramuscular injection in the gluteus for up to 24 months.

Sponsors & Collaborators

  • Janssen Cilag N.V./S.A.

    lead INDUSTRY

Principal Investigators

  • Janssen-Cilag N.V./S.A., Belgium Clinical Trial · Janssen Cilag N.V./S.A.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
17 Years
Max Age
47 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-04-30
Primary Completion
2010-03-31
Completion
2010-03-31

Countries

  • South Africa

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00378092 on ClinicalTrials.gov