A Prospective Study of the Clinical Outcome Following Treatment Discontinuation After Remission in First-Episode Schizophrenia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 主要终点
- 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)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 17 Years 至 47 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
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.
干预措施: Risperidone Long-Acting Injection (RLAI) (Drug)
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.
干预措施: Oral risperidone (Drug)
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.
干预措施: Risperidone Long-Acting Injection (RLAI) (Drug)
结局指标
主要结局
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)
时间窗: Month 36 or early withdrawal (EW)
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).
Percentage of Participants who Relapsed After Discontinuation of RLAI (Period 1)
时间窗: Month 36 or EW
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).
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score After Re-Initiation of RLAI, at Month 24 or EW (Period 2)
时间窗: Baseline and Month 24 or EW
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.
Time to Treatment Response After Re-Initiation of RLAI (Period 2)
时间窗: Month 24 or EW
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.
次要结局
- 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)
- Number of Participants With Disease Remission Based on PANSS (Period 2)(Month 24 or EW)
- Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Month 36 or EW (Period 1)(Baseline and Month 36 or EW)
- Clinical Global Impression of Change (CGI-C) Score at Month 36 or EW (Period 1)(Month 36 or EW)
- Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Month 24 or EW (Period 2)(Baseline and Month 24 or EW)
- Clinical Global Impression of Change (CGI-C) Score in Period 2 at Month 24 or EW (Period 2)(Month 24 or EW)
- Change From Baseline in Calgary Depression Scale Score for Schizophrenia (CDSS) at Month 36 or EW (Period 1)(Baseline and Month 36 or EW)
- Change From Baseline in Calgary Depression Scale Score for Schizophrenia (CDSS) at Month 24 or EW (Period 2)(Baseline and Month 24 or EW)
- Change From Baseline in Social and Occupational Functioning Assessment Scale (SOFAS) Score at Month 36 or EW (Period 1)(Baseline and Month 36 or EW)
- Change From Baseline in Social and Occupational Functioning Assessment Scale (SOFAS) Score at Month 24 or EW (Period 2)(Baseline and Month 24 or EW)
- Change From Baseline in Patient Global Impression-Severity (PGI-S) Score at Month 36 or EW (Period 1)(Baseline and Month 36 or EW)
- Patient Global Impression-Change (PGI-C) Score at Month 36 or EW (Period 1)(Month 36 or EW)
- Change From Baseline in Patient Global Impression-Severity (PGI-S) Score at Month 24 or EW (Period 2)(Baseline and Month 24 or EW)
- Patient Global Impression-Change (PGI-C) Score at Month 24 or EW (Period 2)(Month 24 or EW)
- Change From Baseline in 12-Item Short-Form (SF-12) Score - Quality of Life Survey at Month 36 or EW (Period 1)(Baseline and Month 36 or EW)
- Change From Baseline in 12-Item Short-Form (SF-12) Score - Quality of Life Survey at Month 24 or EW (Period 2)(Baseline and Month 24 or EW)