Follow up of Schizophrenic Patients Following Treatment Discontinuation After Remission From a First Psychotic Episode
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.
|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.|
- 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 ]
- 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 ]
|Study Start Date:||March 2006|
|Study Completion Date:||March 2010|
|Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
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.
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.
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
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.