A Pilot Randomised Controlled Trial of Drug Treatment for Depression in Patients undergoing Haemodialysis

Phase 1

• Conditions: Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]; 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 - Surgical and medical procedures; MedDRA version: 14.1 Level: LLT Classification code 10014647 Term: End stage renal failure System Organ Class: 10038359 - Renal and urinary disorders

• Registration Number: EUCTR2012-000547-27-GB
• Lead Sponsor: East and North Hertfordshire NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-08-21
• Study Completion: 2015-10-13
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 30

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified