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

NCT ID: NCT00378092

Last Updated: 2014-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2010-03-31

Brief 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.

Detailed Description

This is an open-label (all people know the identity of the intervention), prospective (study following participants forward in time), single-arm, single-center study to assess the consequences of treatment discontinuation and evaluate clinical response to re-initiation of risperidone in case of relapse. The study will consist of 2 periods: Period 1 and Period 2. Participants who were on RLAI for 24 months and in remission (when a medical problem gets better or goes away at least for a while) state will enter in Period 1. In Period 1: RLAI will be tapered and discontinued over a period of 6 weeks. Participants will be regularly and carefully followed-up until their first disease relapse or a maximum of 36 months. In case of relapse (i.e., participants experience the same or similar symptoms to those experienced at the time of study entry in the previous Study RIS-PSY-301), participants will be transferred from Period 1 to Period 2. In Period 2, participants will re-start medication with RLAI (25 milligram [mg], 37.5 mg, or 50 mg [maximum]) and simultaneously start on oral (taken by mouth) risperidone (1 mg, 2 mg, or 3 mg). Doses will be adjusted at Investigator's discretion. 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 24 months. Participants will be followed-up until a (new) relapse or the treatment stopped, during a maximum of 24 months. The total duration of the study will be 36 months and will include 16 visits. Assessments will be performed every 2 months in the first year and every 3 months during the following 24 months period. Time to relapse and rate of relapse will be measured as primary outcome for Period 1 and degree of clinical improvement will be measured by Positive And Negative Syndrome Scale (PANSS) total score for schizophrenia. Time to response after re-exposure to treatment with RLAI will be measured as primary outcome for Period 2. Participants' safety will be monitored throughout the study.

Conditions

Schizophrenia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Risperidone Long-Acting Injection (RLAI) (Period 1)

Participants will receive 25 milligram (mg) to 50 mg of RLAI intramuscularly (into the muscle) which will be tapered and discontinued over a period of up to 6 weeks. Participants will be followed-up until their first disease relapse or maximum of 36 months.

Group Type: EXPERIMENTAL

Risperidone Long-Acting Injection (RLAI)

Intervention Type: DRUG

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

Oral risperidone and RLAI (Period 2)

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 (a muscle) for up to 24 months. Supplementation with oral risperidone 1 mg or 2 mg or 3 mg will be administered for 21 days from the first dose of RLAI (until RLAI injections 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.

Group Type: EXPERIMENTAL

Oral risperidone

Intervention Type: DRUG

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.

Risperidone Long-Acting Injection (RLAI)

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Risperdal consta; Risperdal consta

Eligibility Criteria

Inclusion Criteria

Inclusion Criteria: - Participants who completed 24 months RIS-PSY-301 study - Surgically sterile female participants or practicing an effective method of birth control before entry and throughout the study; and must have shown a negative urine serum pregnancy test at baseline before study entry - Participants who have signed informed consent document Exclusion Criteria: - Participants requiring treatment with mood stabilizers or antidepressants at study entry - Participants with 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 before entry - Participants with a history of severe drug allergy, drug hypersensitivity, or neuroleptic malignant (cancerous) syndrome - Participants with known hypersensitivity to risperidone - Participants with acute risk of suicide at study entry or a history of suicidal attempt(s)

• Minimum Eligible Age: 17 Years
• Maximum Eligible Age: 47 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Cilag N.V./S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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

Role: STUDY_DIRECTOR

Janssen Cilag N.V./S.A.

Locations

Bellville, , South Africa

Countries

South Africa

References

Emsley R, Oosthuizen PP, Koen L, Niehaus DJ, Martinez G. Symptom recurrence following intermittent treatment in first-episode schizophrenia successfully treated for 2 years: a 3-year open-label clinical study. J Clin Psychiatry. 2012 Apr;73(4):e541-7. doi: 10.4088/JCP.11m07138.

Reference Type: DERIVED

PMID: 22579160 (View on PubMed)

Related Links

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=248&filename=CR011992_CSR_synopsis.pdf

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

Other Identifiers

RISSCH3024

Identifier Type: -

Identifier Source: secondary_id

CR011992

Identifier Type: -

Identifier Source: org_study_id