Pilot randomised controlled trial of SITAgliptin for Depressive Symptoms in type 2 diabetes - SITADS Study

King's College London0 个研究点目标入组 44 人开始时间: 2016年9月23日最近更新: 2019年12月16日

适应症

试验速览

暂无简介。

•1.A diagnosis of type 2 diabetes according to GP records or clinical guidelines for minimum 6 months
•2.Aged 18-75
•3.Poor glycaemic control defined as HbA1c 53-86 mmol/mol
•4.Already prescribed a first-line anti-diabetes agent (metformin or sulphonylurea) for at least 3 months
•5.Current PHQ-9 score =10
•6.Fluent in conversational English
•7.Able to sign informed consent form
•8.Use of contraception if female and of childbearing age. Female participants will require a negative serum pregnancy test before starting the study and will also need to agree to use an acceptable form of contraception throughout the intervention period, e.g. oral contraceptive pill, long-acting reversible contraceptive.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 44
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 44

•1. Advanced diabetes complications (registered blind, on dialysis, previous above-knee amputation) or treatment with insulin
•2. Pregnancy (tested with serum pregnancy test), planning pregnancy or lactating
•3. Severe mental disorders (psychosis, dementia, learning disability, alcohol/substance dependence, active suicidal ideation)
•4. Non diabetes-related inflammatory condition or history of pancreatitis
•5. Estimated Glomerular Filtration Rate <50ml/minute
•6. Morbid obesity (body mass index >40kg/m2)
•7. HbA1c >86 mmol/mol
•8. Currently prescribed an incretin-based therapy (dipeptidyl peptidase-IV inhibitor or GLP-1 receptor agonist)
•9. Currently prescribed an anti-depressant tablet or in receipt of psychological therapy for depression

发起方