A Follow-Up Study of Schizophrenic Participants Following Treatment Discontinuation After Remission From a First Psychotic Episode
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Oral risperidone; Risperidone Long-Acting Injection (RLAI); Risperidone Long-Acting Injection (RLAI)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 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.; RLAI 25 mg to 50 mg will be administered, intramuscularly which will be tapered and discontinued over a period of up to 6 weeks.; 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.
Other intervention name(s): Risperdal consta; Risperdal consta
Intervention MeSH terms: Risperidone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia; Risperidone; Risperdal consta