Follow up of Schizophrenic Patients Following Treatment Discontinuation After Remission From a First Psychotic Episode

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Cilag N.V./S.A.
ClinicalTrials.gov Identifier:
NCT00378092
First received: September 15, 2006
Last updated: August 28, 2012
Last verified: August 2012
  Purpose

The purpose of this study is to evaluate the outcome of medication discontinuation and the safety and effectiveness of re-initiating Risperidone long acting injectable in case you experience a relapse of schizophrenia during the trial observation period.


Condition Intervention Phase
Schizophrenia
Drug: Oral risperidone
Drug: RLAI
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Study of the Clinical Outcome Following Treatment Discontinuation After Remission in First-episode Schizophrenia.

Resource links provided by NLM:


Further study details as provided by Janssen Cilag N.V./S.A.:

Primary Outcome Measures:
  • To determine the time to relapse after discontinuation of RLAI in first-episode patients successfully treated for 2 years with RLAI. [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
  • To evaluate the time to response after re-exposure to treatment with RLAI. [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the relapse rate after discontinuation of treatment with RLAI. [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • To evaluate the degree of clinical improvement measured by PANSS. [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]

Enrollment: 33
Study Start Date: March 2006
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 001
RLAI Type=1 Unit=37.5mg to 50mg Form=solution for injection route=Intramuscular use. RLAI will be tapered and discontinued over a period of up to 6 weeks.
Drug: RLAI
Type=1, Unit=37.5mg to 50mg, Form=solution for injection, route=Intramuscular use. RLAI will be tapered and discontinued over a period of up to 6 weeks.
Experimental: 002
Oral risperidone Type=1 Unit=1mg to 3mg Form=tablet route=oral use.If relapse of symptoms oral Risperidone will be taken once daily for the first 3 weeks until RLAI injections becomes effective then taper off.,RLAI Type=1 Unit=25mg 37.5mg or 50mg Form=solution for injection route=Intramuscular use. If relapse of symptoms Risperidone injections will be given every 2 weeks for up to 24 months
Drug: Oral risperidone
Type=1, Unit=1mg to 3mg, Form=tablet, route=oral use.If relapse of symptoms, oral Risperidone will be taken once daily for the first 3 weeks until RLAI injections becomes effective then taper off.
Drug: RLAI
Type=1, Unit=25mg,37.5mg,or 50mg, Form=solution for injection, route=Intramuscular use. If relapse of symptoms, Risperidone injections will be given every 2 weeks for up to 24 months

Detailed Description:

After being successfully treated with Risperidone Long-Acting Injectable (RLAI) for 2 years in study RIS-PSY-301 and following current guidelines of treatment of first episode patients, i.e. treating patients for 1-2 years then interrupt treatment, patients were offered to stop treatment and enter in this study. This study consists of 2 periods: Period 1 and Period 2. In Period 1, RLAI will be tapered and discontinued over a period of up to 6 weeks. If patients agree to participate in this study, the doctor will instruct them how to discontinue their medication as follows: At study entry, patients receiving the lowest possible dose of RLAI (25 mg) will not be given any further medication. Patients receiving a higher dose of RLAI will be discontinued from their medication as follows: Patients taking RLAI 37.5mg will receive an injection of RLAI 25mg at visit 1 and no further injections. Patients taking RLAI 50mg will receive an injection of RLAI 37.5mg at visit 1 and 14 days later at visit 2, will receive a last RLAI injection of 25mg.Patients will be regularly and carefully followed up for a maximum of 3 years or until their first disease relapse occurred.In case of a disease relapse (ie, patients experience the same or similar symptoms to those experienced at the time of study entry in the previous trial RIS-PSY-301), patients will be transferred to Period 2 and will re-start medication with RLAI and simultaneously start on oral (taken by mouth) risperidone. Oral Risperidone will only be given for the first 3 weeks until the RLAI injection becomes effective. RLAI injections will continue for up to a maximum of 2 years. The total duration of the trial will be 3 years. Patients will come to the study clinic for a total of 16 assessments during these 3 years. Assessments will be performed every 2 months in the first year and every 3 months during the following 2 years. At months 2, 6, 12, 18, 24, 30 and 36 more detailed assessments (several physical and psychological assessments including completion of a questionnaire will be done than at the other visits at months 4, 8, 10, 15, 21, 27 and 33 (only Positive and Negative Syndrome Scale [PANSS] and Clinical Global Impression of Severity/Change [CGI-S/C] assessments done). The assessments performed are essentially the same as before as in RIS-PSY-301 but some will be done more frequently, such as checking physical movements (ie, walking, etc) via the extrapyramidal symptoms rating scale (ESRS). At all visits adverse events (negative experiences patients may have had since starting the study) and concomitant medication usage will be monitored. At the end of year 1 and 2 blood will be drawn for testing. Additionally an electrocardiogram (ECG) will be performed at the start of trial medication and at trial end. For patients who experience a relapse, oral risperidone and RLAI injections will be initiated simultaneously. Risperidone oral (by mouth) tablets once daily (1 milligram[mg], 2mg, or 3mg ) for 3 weeks and then taper off. Risperidone injections (25mg, 37.5mg, or 50mg [max]) every 2 weeks for 24 months. Doses may be increased or decreased at investigator's discretion.

  Eligibility

Ages Eligible for Study:   17 Years to 47 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Previous participation in clinical trial RIS-PSY-301 completed.

Exclusion Criteria:

  • Evidence of alcohol or drug abuse or dependence (except for nicotine and caffeine dependence) according to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria diagnosed in the last month prior to entry
  • Known hypersensitivity to risperidone
  • Patients with acute risk of suicide at study entry or a history of suicidal attempt(s).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00378092

Sponsors and Collaborators
Janssen Cilag N.V./S.A.
Investigators
Study Director: Janssen-Cilag N.V./S.A., Belgium Clinical Trial Janssen Cilag N.V./S.A.
  More Information

Additional Information:
No publications provided by Janssen Cilag N.V./S.A.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Janssen Cilag N.V./S.A.
ClinicalTrials.gov Identifier: NCT00378092     History of Changes
Other Study ID Numbers: CR011992, RISSCH3024
Study First Received: September 15, 2006
Last Updated: August 28, 2012
Health Authority: Belgium: Ministry of Social Affairs, Public Health and the Environment

Keywords provided by Janssen Cilag N.V./S.A.:
Schizophrenia
First episode
Relapse
Long acting risperidone

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Risperidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on April 17, 2014