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

NCT00378092 | Completed Phase 4

• 2 other identifiers: CR011992RISSCH3024
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Keywords

Schizophrenia; Risperidone; Risperdal consta

Outcome Measures

Primary Outcomes (4)

• Time to Relapse After Discontinuation of Risperidone Long-Acting Injection (RLAI) in First-Episode Participants Successfully Treated for 24 Months With RLAI in Previous Study (RIS-PSY-301) (Period 1)

  Relapse will be diagnosed if 1 or more of the following occurs: a 25 percent increase in Positive and Negative Syndrome Scale (PANSS) total score ranging from 30 (absent) to 210 (extreme ill); Clinical Global Impression (CGI-C) score of 6 ('much worse'); deliberate self-injury (as per adverse event \[AE\] reporting); emergence of clinically significant suicidal or homicidal ideation (as per AE reporting); or violent behavior resulting in significant injury to another person or significant property damage (as per AE reporting).

  Month 36 or early withdrawal (EW)

• Percentage of Participants who Relapsed After Discontinuation of RLAI (Period 1)

  Relapse will be diagnosed if 1 or more of the following occurs: a 25 percent increase in PANSS total score ranging from 30 (absent) to 210 (extreme ill); CGI-C score of 6 ('much worse'); deliberate self-injury (as per AE reporting); emergence of clinically significant suicidal or homicidal ideation (as per AE reporting); or violent behavior resulting in significant injury to another person or significant property damage (as per AE reporting).

  Month 36 or EW

• Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score After Re-Initiation of RLAI, at Month 24 or EW (Period 2)

  The PANSS is a medical scale that assesses various symptoms of schizophrenia and provides a total score (sum of the scores of all 30 items) and scores for 3 subscales: positive subscale (7 items), negative subscale (7 items), and general psychopathology subscale (16 items), each rated on a scale of 1 (absent) to 7 (extreme). The total score is the sum of all 30 PANSS items, with a range of 30 (absent) to 210 (extreme ill). Higher scores indicate worsening.

  Baseline and Month 24 or EW

• Time to Treatment Response After Re-Initiation of RLAI (Period 2)

  Time to treatment response after re-initiation of RLAI will be the time that elapse between Baseline assessment of PANSS for Period 2 and fulfilment of the response which is defined as greater than or equal to 20 percent improvement in PANSS total score. PANSS is a medical scale that assesses various symptoms of schizophrenia and provides a total score (sum of the scores of all 30 items) with a range of 30 (absent) to 210 (extreme ill). Higher scores indicate worsening.

  Month 24 or EW

Secondary Outcomes (20)

• Change From Baseline in PANSS Total Score and Subscales of PANSS at Month 36 or EW (Period 1)

  Baseline and Month 36 or EW

• Change From Baseline in PANSS Total Score and Subscales of PANSS at Month 24 or EW (Period 2)

  Baseline and Month 24 or EW

• Change From Baseline in Marder PANSS Subscales Score at Month 36 or EW (Period 1)

  Baseline and Month 36 or EW

• Change From Baseline in Marder PANSS Subscales Score at Month 24 or EW (Period 2)

  Baseline and Month 24 or EW

• Number of Participants With Disease Remission Based on PANSS (Period 1)

  Month 36 or EW

Study Arms (2)

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

EXPERIMENTAL

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.

Drug: Risperidone Long-Acting Injection (RLAI)

Oral risperidone and RLAI (Period 2)

EXPERIMENTAL

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.

Drug: Oral risperidone; Drug: Risperidone Long-Acting Injection (RLAI)

Interventions

Oral risperidone 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.

Oral risperidone and RLAI (Period 2)

Risperidone Long-Acting Injection (RLAI) 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.

Also known as: Risperdal consta

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

Eligibility Criteria

• Age: 17 Years - 47 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

Sponsors & Collaborators

• Janssen Cilag N.V./S.A.: lead

Study Sites (1)

Unknown Facility

Bellville, South Africa

Location

Related Publications (1)

• 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.

  PMID: 22579160 DERIVED

Related Links

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

MeSH Terms

Conditions

Schizophrenia

Interventions

Risperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

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

  Janssen Cilag N.V./S.A.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2006
• First Posted: September 19, 2006
• Study Start: April 1, 2006
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: May 8, 2014

Record last verified: 2014-05

Locations

ZA (1)