Risk of Breakthrough Symptoms On Antipsychotic Maintenance Medication When Remitted Patients Are Treated With Long-Acting Injectable Medications
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Clinical Global Impressions Schizophrenia Scale (CGI-SCH) - Positive Symptoms Change subscale
研究概览
简要总结
This prospective longitudinal cohort study will follow patients with schizophrenia who are treated with second generation long-acting injectable antipsychotic medications (LAIs) for 48 weeks to determine the risk of psychotic symptom relapse when treatment adherence is established. The study is designed to minimize the other factors that have contributed to breakthrough psychotic symptoms in patients treated with LAIs including poor adherence, substance use, concurrent mood disorders, poor treatment response, failed cross-titration, and insufficient dosing. Eligible subjects will undergo a screening visit to document that inclusion criteria are met and those meeting exclusion criteria are excluded. Participants will be assessed every 12 weeks to determine whether they remain in remission or meet criteria for a relapse. More comprehensive assessment will be completed at the beginning of the study (baseline visit), at the 24-week study midpoint and the 48-week study endpoint. Plasma antipsychotic levels will be measured at these three study time points to investigate associations between plasma levels and remission/relapse status as well as side effects. Plasma prolactin will also be measured to assess the association with sexual side effects. Hemoglobin A1c and measures of total cholesterol, triglycerides, HDL cholesterol and LDL cholesterol will be obtained to assess the effects of SGA LAIs on these measures.
详细描述
Rationale and Study Objectives In this study, we aim to determine the likelihood that relapse of psychosis will occur when patients with schizophrenia who have experienced a remission of their psychotic symptoms are adherent to treatment with a second generation antipsychotic (SGA) LAI on which they have been stable at a therapeutic dose for at least three months.
Primary objective:
1. To estimate the rate of psychotic relapse in patients with schizophrenia whose psychotic symptoms have remitted and who are adherent with second generation LAIs for maintenance treatment.
Secondary objectives:
1. To determine whether the risk of psychotic relapse is associated with antipsychotic plasma levels in patients treated with second generation LAIs.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DSM-5 Schizophrenia
- •Age 18-65 years
- •On SGA LAI: paliperidone palmitate (4-week or 12-week formulations), risperidone or aripiprazole
- •Receiving LAI injections through clinical services based at CAMH
- •History of improvement in psychotic symptoms with antipsychotic medication as evidenced by a rating of mild or less on the Clinical Global Impression - Severity (CGI-S) for Positive symptoms
- •Demonstrated adherence to LAIs defined as not having received any injections more that 7 days past its due date in the past 3 months
- •On stable dose of LAI for 3 months or longer
- •Capable of providing informed consent for participation in this study
排除标准
- •Current DSM-5 major depressive episode or manic episode
- •Receiving any oral antipsychotic medication in the past 3 months
- •History of organic brain disease (e.g. cerebrovascular accident, Huntington's Disease, Parkinson's Disease, epilepsy, etc.)
- •History of untreated or unstable medical illness (e.g. thyroid disease, cancer)
- •History of electroconvulsive therapy (ECT) in the past year
- •History of suicide attempt in the past 3 months
- •History of psychiatric hospitalization in the past 3 months
- •Inability to read and communicate in English
研究组 & 干预措施
SGA-LAI
Outpatients with schizophrenia treated with second generation long-acting injectable antipsychotics whose psychotic symptoms have remitted.
干预措施: Second Generation Long-Acting Injectable Antipsychotic Medications (Drug)
结局指标
主要结局
Clinical Global Impressions Schizophrenia Scale (CGI-SCH) - Positive Symptoms Change subscale
时间窗: Assessed at 12 weeks, 24 weeks, 36 weeks and 48 weeks
Subjects will be considered to have relapsed during the study if they are assessed as having a change score of 6 ("much worse") or 7 ("very much worse") on the Clinical Global Impressions Schizophrenia Scale (CGI-SCH) - Positive Symptoms Change subscale (Haro et al., 2003). The minimum score on this scale is "1" - "Very much improved" and the maximum score is "7" - "Very much worse". A higher score means a worse outcome.
次要结局
- Personal and Social Performance Scale(Assessed at 24 weeks and 48 weeks)
- Clinical Global Impression Schizophrenia scale(Assessed at 24 weeks and 48 weeks)
- Single-Item Happiness Questionnaire(Assessed at 24 weeks and 48 weeks)
- Subjective Well-Being Under Neuroleptics Scale(Assessed at 24 weeks and 48 weeks)
- Brief Psychiatric Rating Scale(Assessed at 24 weeks and 48 weeks)
- Calgary Depression Scale(Assessed at 24 weeks and 48 weeks)
- VAGUS Insight Into Psychosis Scale(Assessed at 24 weeks and 48 weeks)
- Quality of Life Scale(Assessed at 24 weeks and 48 weeks)
- Satisfaction with Life Scale(Assessed at 24 weeks and 48 weeks)
- UKU Side Effect Rating Scale(Assessed at 24 weeks and 48 weeks)
- Barnes Akathisia Scale(Assessed at 24 weeks and 48 weeks)
- Arizona Sexual Experiences Scale(Assessed at 24 weeks and 48 weeks)