Clinical trial NCT00378092: A Follow-Up Study of Schizophrenic Participants Following Treatment Discontinuation After Remission From a First Psychotic Episode
Official title: A Prospective Study of the Clinical Outcome Following Treatment Discontinuation After Remission in First-Episode Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Keywords: Schizophrenia
Risperidone
Risperdal consta
Lead sponsor: Janssen Cilag N.V./S.A.
Sponsor class: INDUSTRY
First posted: 2006-09-19
Enrollment: 33
Sex: ALL
Minimum age (years): 17
Maximum age (years): 47
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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)

Primary outcomes:
measure: 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)
timeFrame: Month 36 or early withdrawal (EW)
measure: Percentage of Participants who Relapsed After Discontinuation of RLAI (Period 1)
timeFrame: Month 36 or EW
measure: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score After Re-Initiation of RLAI, at Month 24 or EW (Period 2)
timeFrame: Baseline and Month 24 or EW
measure: Time to Treatment Response After Re-Initiation of RLAI (Period 2)
timeFrame: Month 24 or EW
Secondary outcomes:
measure: Change From Baseline in PANSS Total Score and Subscales of PANSS at Month 36 or EW (Period 1)
timeFrame: Baseline and Month 36 or EW
measure: Change From Baseline in PANSS Total Score and Subscales of PANSS at Month 24 or EW (Period 2)
timeFrame: Baseline and Month 24 or EW
measure: Change From Baseline in Marder PANSS Subscales Score at Month 36 or EW (Period 1)
timeFrame: Baseline and Month 36 or EW
measure: Change From Baseline in Marder PANSS Subscales Score at Month 24 or EW (Period 2)
timeFrame: Baseline and Month 24 or EW
measure: Number of Participants With Disease Remission Based on PANSS (Period 1)
timeFrame: Month 36 or EW
measure: Number of Participants With Disease Remission Based on PANSS (Period 2)
timeFrame: Month 24 or EW
measure: Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Month 36 or EW (Period 1)
timeFrame: Baseline and Month 36 or EW
measure: Clinical Global Impression of Change (CGI-C) Score at Month 36 or EW (Period 1)
timeFrame: Month 36 or EW
measure: Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Month 24 or EW (Period 2)
timeFrame: Baseline and Month 24 or EW
measure: Clinical Global Impression of Change (CGI-C) Score in Period 2 at Month 24 or EW (Period 2)
timeFrame: Month 24 or EW
measure: Change From Baseline in Calgary Depression Scale Score for Schizophrenia (CDSS) at Month 36 or EW (Period 1)
timeFrame: Baseline and Month 36 or EW
measure: Change From Baseline in Calgary Depression Scale Score for Schizophrenia (CDSS) at Month 24 or EW (Period 2)
timeFrame: Baseline and Month 24 or EW
measure: Change From Baseline in Social and Occupational Functioning Assessment Scale (SOFAS) Score at Month 36 or EW (Period 1)
timeFrame: Baseline and Month 36 or EW
measure: Change From Baseline in Social and Occupational Functioning Assessment Scale (SOFAS) Score at Month 24 or EW (Period 2)
timeFrame: Baseline and Month 24 or EW
measure: Change From Baseline in Patient Global Impression-Severity (PGI-S) Score at Month 36 or EW (Period 1)
timeFrame: Baseline and Month 36 or EW
measure: Patient Global Impression-Change (PGI-C) Score at Month 36 or EW (Period 1)
timeFrame: Month 36 or EW
measure: Change From Baseline in Patient Global Impression-Severity (PGI-S) Score at Month 24 or EW (Period 2)
timeFrame: Baseline and Month 24 or EW
measure: Patient Global Impression-Change (PGI-C) Score at Month 24 or EW (Period 2)
timeFrame: Month 24 or EW
measure: Change From Baseline in 12-Item Short-Form (SF-12) Score - Quality of Life Survey at Month 36 or EW (Period 1)
timeFrame: Baseline and Month 36 or EW
measure: Change From Baseline in 12-Item Short-Form (SF-12) Score - Quality of Life Survey at Month 24 or EW (Period 2)
timeFrame: Baseline and Month 24 or EW
Other outcomes:
Locations:
city: Bellville
country: South Africa
Study officials:
affiliation: Janssen Cilag N.V./S.A.
name: Janssen-Cilag N.V./S.A., Belgium Clinical Trial
role: STUDY_DIRECTOR
References:
citation: 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.