Major Depressive Disorder in Patients with End Stage Renal Disease MedDRA version: 14.1 Level: LLT Classification code 10025453 Term: Major depressive disorder NOS System Organ Class: 10037175 - Psychiatric disorders MedDRA version: 14.1 Level: LLT Classification code 10066623 Term: Chronic haemodialysis System Organ Class: 10042613 -
Conditions
Interventions
Trade Name: Sertralin - 1 A Pharma® 50 mg Filmtabletten
Product Name: Sertraline
Pharmaceutical Form: Capsule
INN or Proposed INN: Sertraline hydrochlor
Sponsors
East and North Hertfordshire NHS Trust
University of Hertfordshire
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For the prevalence and screening part of the study the inclusion criteria are: 1)Patients with ESRD and on haemodialysis. They will have started dialysis at least 3 months previously and have continued to receive dialysis in the 3 months prior to the invitation to participate in this study. 2)Adults aged 18 or over. 3)Patients who speak and read English sufficiently well to complete questionnaires. For the clinical trial part of the study the inclusion criteria are: 4)Patients with a BDI II score of 16 or above. 5)Patients, who according to the nephrologist, have more than one year prognosis. 6)Patients with a diagnosis of Major Depressive Disorder according to a DSM IV interview conducted by a psychiatrist. 7)Patients who score 18 or above on the Montgomery-Åsberg Depression Rating Scale (MADRS). Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 45 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: The exclusion criteria for the clinical trial are: 1)Patients who are currently being or have been treated for depression and/or anxiety with any antidepressants in the last 3 months. 2)Patients who are currently being or have been treated for depression and/or anxiety with a formal psychological therapy in the last 3 months. 3)Patients who are awaiting a planned living donor transplant within the period of the trial. 4)Patients who have less than a year survival prognosis according to the nephrologist. 5)Patients for whom Sertraline is contraindicated by their existing drug regimen according to the Summary of Product Characteristic. 6)Patients with hepatic impairment, whose serum level of Alanine transaminase (ALT) is 2 times the upper limits of normal or higher. 7)Patients who have hepatitis B or hepatitis C, HIV/AIDS, and/or Creutzfeldt-Jakob disease. 8)Patients who are pregnant or of childbearing potential who are not using adequate contaception. 9)Patients who are or have been involved in an intervention study in the last 3 months. 10)Patients’ with impaired coagulation judged by an International normalised ratio (INR) greater than 1.3. 11)Patients who are currently taking MAOIs or pimozide. 12)Patients who are currently taking triptans, antipsychotics, dopamine antagonists, tramadol, linezolid, and warfarin. 13)Patients at moderate to severe risk of self-harm according to the assessment of the study psychiatrist. 14)Patients who score above 4 on item 10 on the MADRS. 15)Patients who answer yes to question A3G on the Mini-International Neuropsychiatric Interview (MINI) . 16)Patients who have other known psychiatric condition, including substance misuse, psychosis, or personality disorder.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main research question is to evaluate the feasibility of conducting a randomised, double blind, placebo pilot trial in patients with end stage renal disease (ESRD) and depression. The treatment under investigation is Sertraline, a licensed anti-depressant. The study is split into four phases. Phase one will evaluate the number of ESRD patients eligible for this clinical trial. Phase two will assess the feasibility of conducting a randomised drug trial in this group of patients, by measuring the number who take part. Phase three will look at the safety and drug exposure of Sertraline in ESRD patients and phase four will explore the patient experience of participating in this trial.;Secondary Objective: The secondary research questions will atttempt to quantify the variability in the outcome measures (including quality of life) for the treatment and placebo arms, allowing an assessment of effect sizes, effects of treatment centre, and bias due to missing data. The study will also try to evaluate the gain in the outcome measures in treated patients compared to those in the control group and whether changes in these measures over time can be attributed to treatment. This is a pilot study and a statistically significant outcome in this domain is unlikely. Establishing the effect size though will be of crucial importance in powering future definitive trials.;Primary end point(s): Our primary outcome for the study is the proportion of eligible patients approached who agree to enter the study and complete the study. In addition, for phase one, are main outcome is the number of people on haemodialysis who screen positive on the Beck Depression Inventory II. For phase three, to measure plasma levels of Sertraline in pre and post dialysis patients and phase four to explore the patients' views regarding the facilitators and barriers to participation in the trial.;Timepoint(s) of evaluation of this end point: The pilot trial is 6 months long and the primary | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): There are a number of secondary outcomes. For phase one, we are interested in the eligibility of patients into this phase, looking at the number of haemodialysis patients that score positive on the Patient Health Questionnaire 9 and compare these scores with the Beck Depression Inventory II scores. For phase two, our secondary outcome measures are: 1) The proportion of patients who score positive on the BDI-II and are eligible for the psychiatric diagnostic interview. 2) The number of and reasons for patients not meeting the initial eligibility criteria applied by the CI/PIs in the trial outcome and safety and drug exposure phases. 3) The proportion of interview eligible patients who agree to take part in the psychiatric diagnostic interview. 4) The proportion of interview eligible patients who choose not to take part in the psychiatric diagnostic interview and reasons given (as well as alternative care chosen). 5) The proportion of patients who are diagnosed with a major depressive disorder according to the psychiatric diagnostic interview. 6) The proportion of eligible patients who agree to take part in the trial outcome and safety and drug exposure phases. 7) The proportion of eligible patients who refuse to take part in the trial outcome and safety and drug exposure phases and the reasons given (including description of alternative health options chosen). 8) The proportion of recruited patients who withdraw from the trial outcome and safety and drug exposure phases, the stage of withdrawal and the reason(s) for withdrawal. 9) The number of recruited patients who complete the baseline assessment. 10) The number of recruited patients who complete the follow-up assessments. 11) The proportions of complete and missing data, and the characteristics of the missing data. 12) The number, range and extent of adverse events reported. 13) To quantify the variability in the outcome measures (including QoL) for the treatment and placebo arms, all | — |
Countries
United Kingdom
Contacts
Public ContactDr Karin Friedli
University of Hertfordshire
Outcome results
None listed