Drug treatment for depression in patients undergoing haemodialysis

• Register: ISRCTN
• Last refreshed on: 25 November 2019
• Main ID: ISRCTN06146268
• Date of registration: 01/05/2014
• Prospective Registration: No
• Primary sponsor: East and North Herts NHS Trust (ENHT) (UK)
• Public title: Drug treatment for depression in patients undergoing haemodialysis
• Scientific title: A pilot randomised controlled trial of drug treatment for depression in patients undergoing haemodialysis
• Date of first enrolment: 15/04/2013
• Target sample size: 30
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN06146268
• Study type: Interventional
• Study design: Pilot double-blind parallel-group placebo-controlled randomised trial (Treatment)
• Phase: Not Applicable

Countries of recruitment

United Kingdom

Contacts

• Name: Ken Farrington

Key inclusion & exclusion criteria

Inclusion criteria:
1. Screening eligibility:
1.1. Patients with ESRD and receiving haemodialysis. They will have started dialysis at least 3 months ago and have continued to receive dialysis in the past 3 months prior to the invitation to take part in this study
1.2. Adults aged 18 or over
1.3. Patients who speak and read English sufficiently well to complete questionnaires
2. Trial eligibility:
2.1. Patients with a Beck Depression Inventory (BDI-II) of 16 or above
2.2. Patients who, according to the CI/PIs, have a prognosis of more than 1 year
2.3. Patients with a diagnosis of mild to moderate Major Depressive Disorder according to a Diagnostic and Statistical Manual of Mental Disorders (DSM) IV interview conducted by a research psychiatrist
2.4. Patients who score 18 or above on the Montgomery-Asberg Depression Scale (MADRS)
2.5. Patients who have the mental capacity to understand the trial and are able to give consent

Exclusion criteria:
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 1 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 Characteristics
6. Patients with hepatic impairment, whose serum level of alanine transaminase (ALT) is two 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 with a diagnosis of a severe Major Depressive Disorder
14. Patients at moderate to severe risk of self-harm according to the assessment of the study psychiatrist
15. Patients who score above 4 on item 10 on the MADRS
16. Patients who answer yes to question A3G on the Mini-International Neuropsychiatric Interview (MINI)
17. Patients who have other known psychiatric conditions, including substance misuse, psychosis, or personality disorder, dementia or panic disorder, with the exception of other anxiety disorders (for example GAD or OCD)


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Topic: Mental Health, Renal disorders; Subtopic: Depression, Renal disorders; Disease: Depression
Mental and Behavioural Disorders
Depressive episode, unspecified

Intervention(s)

The main research question is to evaluate the feasibility of conducting a randomised, double-blind, placebo-controlled trial in patients with ESRD and depression. The treatment under investigation is sertraline, a licensed SSRI. The study is split into three phases. Phase one will evaluate the number of ESRD patients who score as depressed on the Beck Depression Inventory. Phase two will assess the feasibility of conducting a randomised drug trial in this group of patients by assessing the number who take part and evaluating their outcomes including the safety and drug exposure of sertraline in ESRD patients. Phase three will explore the patient experience of participating in a trial and taking additional medication. This is a pilot study looking at running a phase IV, double-blind, placebo-controlled, randomised trial with two arms (sertraline hydrochloride versus placebo). A block randomisation on a web-based programme has been prepared by Norwich CTU. Patients will be starting on the study medication 50 mg orally per day for 2 months, with the option of stepping up to 100 mg orally for the remainder of the trial, if clinically indicated. Patients will remain on the study medication and followed up for 6 months.

Contact details for patient information sheet:
Dr Karin Friedli
Trial Manager
Centre for Lifespan and Chronic Illness Research
University of Hertfordshire
College Lane
Hatfield AL10 9AB
United Kingdom
[e-mail]

Primary Outcome(s)

The primary outcome measures relate to the feasibility of conducting a large-scale randomised controlled trial. The aim is to characterise:
1. The proportion of eligible patients
2. The extent to which patients refuse to take part
3. The number who complete the study

Secondary Outcome(s)

The secondary aims are to assess the acceptability of and adherence to the study treatment, to assess how missing data biases the study outcomes, and to record the reported adverse events and safety of the study treatment in this group of patients

The analysis will estimate the variability in BDI, MFI, SF-36 energy/fatigue subscale, PHQ-9, MADRS, KDQoL and EQ5D scores.

Secondary ID(s)

2012-000547-27

14560

Source(s) of Monetary Support

NIHR Research for Patient Benefit (RfPB) (UK); Grant Codes: PB-PG-0110-21073

Secondary Sponsor(s)

University of Hertfordshire (UK)

Ethics review

Status:
Approval date:
Contact:

NRES Committee London - Bentham, 01/11/2012, ref: 12/LO/1554

Results

• Results available: Yes
• Date Completed: 28/02/2015