Effect of Selective Serotonin Reuptake Inhibitor on Satiety Function in Patients With Functional Dyspepsia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- To evaluate the change of serotonin and ghrelin level in blood plasma before and after treatment
研究概览
简要总结
Background:
Functional dyspepsia is one of the commonest digestive disorders. The pathophysiology of functional dyspepsia (FD) is uncertain. Clinical experience and community studies show that FD is strongly associated with common mood disorders especially depression and anxiety disorders, which can be treated with serotonin selective uptake receptor (SSRI).
Our previous study shows that the relief of FD symptom has an association with the change of plasma serotonin and ghrelin profile. However, the correlation between plasma serotonin level in FD patients treated with SSRI is lacking in these studies.
Indication:
Functional dyspepsia patients
Study center(s):
Prince of Wales Hospital, Hong Kong
Aims :
- To evaluate the effect of SSRI treatment on change of plasma serotonin level
- To evaluate the relationship between dyspeptic symptom and change of plasma serotonin level
Study medication:
Escitalopram (Lexapro) 5mg daily for first 2 weeks, and then 10 mg daily for 8 weeks versus Placebo for 10 weeks
Study design:
Double-blind randomized placebo-controlled trial
Number of subjects:72
- 36 patients (18 male and 18 female) and 36 age-and-sex-matched healthy controls
Patient population:
Functional dyspepsia patients age 18-60, with element of anxiety or depression
Duration of study: 1 June 2013 - 30 November 2015
Primary variable(s):
Change of serotonin and ghrelin level in blood plasma after medication treatment
Secondary variable(s):
Rate of adequate relief using global symptom assessment and symptom scores
Number of visits: 2
详细描述
Baseline assessment:
- Demographic: age, gender
- Anthropometric measurements: body mass index, height, weight and waist circumference
- FGI Screening Questionnaire (v.3, 20101011) for screening of functional gastrointestinal disorder according to Rome III criteria.
- Duration of dyspeptic symptoms will be recorded
- A combined Functional GI symptom Questionnaire (FGISQ) (version: FGISQ 20110504) based on recall of the past 7 days will be used for assessment al GI symptoms including regurgitation, heartburn, epigastric pain, postprandial fullness, abdominal pain, diarrhea, constipation etc. All questions use a 4-point (0-3) Likert scale.
- Patient Health Questionnaire (PHQ) and Hospital Anxiety and Depression Scale (HADS) will be used for screening of concomitant psychological disorder such as depression and generalized anxiety disorder.
- BECK Anxiety Inventory (BAI), BECK Depression Inventory (BDI) and Anxiety Sensitivity Index-Revised (ASI-R) will be used for monitor the change of mood status.
- Trained interviewers perform semi- structured clinical interview using the Chinese-Bilingual version of the Structured Clinical Interview for DSM Mental Disorders-IV to assess for lifetime and current diagnoses of depressive and anxiety disorders (female patients only)
Satiety test and ghrelin profile:
After an overnight fast, the patients are instructed to ingest Ensure® (1.06 kcal/ml; 22% fat, 64% carbohydrate, and 14% protein) at constant rate of 30ml/min for a fixed calorie test of 28 minutes (Total calorie: 890.4 kcal). They are required to complete a Fullness Rating Scale (FRS) at 3-min intervals (ie. 0min, 3min, 6min...). Initial Blood sample of 16 ml will be taken (10ml will be taken preprandially for storage in future identification of biomarkers for functional GI disorders and 6 ml for assay of ghrelin and serotonin profile). Another blood sample (6 ml) will be taken at 120min for assay of ghrelin and serotonin profile.
The test will be performed at baseline (V1) and after medication treatment (V2).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• Patients with functional dyspepsia that fulfill Rome III criteria
- •Has element of anxiety or depression reported at baseline screened by HADS (either subscale of HADS - HAS or HDS scores 8 or higher)
- •Age 18-60
- •Provision of written consent
- •No evidence of structural disease (including at upper endoscopy) that is likely to explain the dyspeptic symptoms
排除标准
- •• Diabetes mellitus
- •Organic brain syndrome
- •Moderate or severe Depression diagnosed by Structured Clinical Interview for DSM-IV conducted by a psychiatrist or trained research staff
- •History of psychosis, bipolar disorder or substance abuse/dependence
- •On psychiatric medication (SSRI, SNRI, tricyclic antidepressants, anxiolytics)
- •Has suicidal ideation in the past two weeks as screened by PHQ at baseline assessment
- •Diagnosis of GERD by GERDQ questionnaire (GERDQ score ≥8) included in the FGI Screening Questionnaire (v.3) completed at baseline visit
- •Concurrent medications that affect GI motility
- •History of gastric surgery
- •Organic disease as cause of dyspepsia
- •H. pylori infection
- •Use of PPI or NSAID in the past 4 weeks
- •Pregnancy
- •Known hypersensitivity to SSRI
- •Unable to read Chinese or illiterate
研究组 & 干预措施
Escitalopram
Escitalopram 5mg & 10mg daily
干预措施: Escitalopram (Drug)
Control (Placebo) group
Identical looking placebo (once daily)
Double blinding of study medication is achieved by repacking Escitalopram 5mg and 10mg as blue and green capsules respectively.. Identical appearing placebos packed in blue and green capsules will be used for the control group.
干预措施: Placebo (Other)
结局指标
主要结局
To evaluate the change of serotonin and ghrelin level in blood plasma before and after treatment
时间窗: Week 8
evaluate the change of serotonin and ghrelin level in blood plasma before and after treatment
次要结局
- To measure expression of serotonin and ghrelin blood plasma using global symptom assessment, symptom scores and the fullness rating of the Fullness Rating Scale (FRS) during satiety test(At 28 minute on satiety test)
- To measure the rate of adequate relief using global symptom assessment, symptom scores and the fullness rating of the Fullness Rating Scale (FRS) during satiety test(During 28 minute of satiety test)
研究者
Justin Che-Yuen Wu
Professor
Chinese University of Hong Kong