Prevalence Study of Sialorrhea in Inpatients and Outpatients Treated With Clozapine
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 129
- 试验地点
- 1
- 主要终点
- Prevalence of sialorrhea in patients treated with clozapine
研究概览
简要总结
Clozapine is the "gold standard" antipsychotic drug for the treatment of resistant schizophrenia or resistant psychosis. Despite the high rates of good clinical response, the potential side effects can limit its use. Sialorrhea or excessive salivation is a side effect that occurs in 30-80% of people who receive this treatment and it can cause a decrease in self-esteem and feeling of security, greater social isolation and increase stigma.
The main objective of this study is to measure the prevalence of sialorrhea in inpatients and outpatients treated with clozapine and its consequences on the quality of life of people who are receiving this treatment.
A total of 129 patients over 18 years of age in treatment with clozapine will be recruited from different units of the Institute of Neuropsychiatry and Addictions (INAD) of the Parc de Salut Mar.
Sialorrhea will be evaluated by the nursing team with the Nocturnal Hypersalivation Rating Scale (NHRS), the Scale of Frequency and severity of salivation and the scale of impact on the quality of life. Also sociodemographic variables such as age, date of birth, race, date of diagnosis and clinical variables such as diagnosis, dose of clozapine and other treatments prescribed will be collected.
详细描述
BACKGROUND:
Clozapine is an atypical antipsychotic drug considered the "gold standard" in the treatment of resistant psychosis and also in patients who have had adverse effects with others drugs previously indicated as first line. It has been described that almost two thirds of patients who do not respond to first and second generation antipsychotics respond to clozapine treatment. Despite its effectiveness in positive, negative symptoms and the risk of suicide, clozapine presents a risk of adverse effects ranging from potentially dangerous ones. such as agranulocytosis or myocarditis, to others that are considered mild but that they can compromise the quality of life of patients and non-compliance. One of these mild, but extremely annoying, side effects is sialorrhea. The prevalence of sialorrhea secondary to clozapine reported by different studies range from 30% to 80% and it seems to be a dose-dependent relationship. This great variability observed in the studies probably has to do with the tendency that clinicians have to underestimate this side effect. In addition, the presence of sialorrhea can impact negatively in the subject causing a decrease in self-esteem and feeling of security, greater social isolation and an increase in stigma.
JUSTIFICATION OF THE STUDY:
Due to the consequences that sialorrhea has on the quality of life perceived by people in Clozapine treatment and the relationship with possible therapeutic abandonment, in addition to the low systematic evaluation of this side effect, it is considered relevant to establish a systematic evaluation of clozapine induced sialorrhea in the different mental health devices of our center.
OBJECTIVES:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •People over 18 years
- •In- and outpatients from different INAD Units
- •Clozapine treatment with a stable dose (minimum one month without dose changes)
排除标准
- •People under 18 years
- •People receiving antipsychotic treatment other than clozapine (even though they present sialorrhea due to this treatment).
- •It will not be exclusion criteria to be in treatment with other antipsychotics in conjunction with clozapine.
结局指标
主要结局
Prevalence of sialorrhea in patients treated with clozapine
时间窗: 1 week
Prevalence of daytime sialorrhea measured by Drooling Severity and Frequency Scale. The scale has two parts: one measures severity between 0-5 and the other measure frequency between 1-4. The higher the score, the more severe it is.
Prevalence of nocturnal sialorrhea in patients treated with clozapine
时间窗: 1 week
Prevalence of sialorrhea measured by Nocturnal hypersalivation rating scale. The values range from 0 to 4, the higher the score the greater the severity.
次要结局
- Decrease in quality of life due to hypersalivation(1 week)
研究者
Alicia Valiente
Professor
Parc de Salut Mar