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A double-blind, placebo-controlled trial of Zoloft's® Effects on Symptoms and survival Time in Advanced Cancer
ISRCTN ISRCTN72466475
DOI 10.1186/ISRCTN72466475
ClinicalTrials.gov identifier
EudraCT number
Public title A double-blind, placebo-controlled trial of Zoloft's® Effects on Symptoms and survival Time in Advanced Cancer
Scientific title
Acronym The ZEST Trial
Serial number at source Version 1.0, dated October 2004 - ACTRN012605000381684
Study hypothesis Not provided at time of registration
Lay summary
Ethics approval Not provided at time of registration
Study design Double-blind placebo-controlled trial
Countries of recruitment Australia
Disease/condition/study domain Advanced Cancer
Participants - inclusion criteria 1. Advanced cancer defined by the presence of metastatic disease and treatment with palliative intent, that is to improve length and quality of life, but without realistic hope of cure
2. Symptomatic score greater than or equal to 4/10 for depression, anxiety, fatigue or lack of energy at baseline (assessment tool: Patient DATA form)
3. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
4. Life expectancy of >3 months
5. Serum creatinine <200 µmol/l and bilirubin <30 µmol/l within 28 days of randomization
6. Able to complete baseline quality of life instruments
7. Availability and willingness for follow-up
8. Written informed consent
9. Women of childbearing potential must be taking adequate contraceptive precautions
Participants - exclusion criteria 1. Major depression, in other words, a clear indication for antidepressant treatment
2. Delirium i.e. impaired cognitive function (as detected by the Confusion Assessment Method, a screening tool for delirium assessing onset, course, inattention, disorganised thinking, level of consciousness)
3. History of hypersensitivity to sertraline
4. Diagnosis of carcinoid tumour
5. Coexisting conditions contraindicating treatment with serotonin reuptake inhibitors
6. Past history of schizophrenia or bipolar affective disorder
7. Treatment with antidepressants (including St John's Wort) or procarbazine within the last 4 weeks. Amitriptyline may be used at a daily dose of 25 mg or less as a co-analgesic or for urinary frequency, and is not an exclusion criterion.
8. Pregnant or lactating women. Women of childbearing potential are eligible if taking adequate contraceptive precautions.
9. Treatment with Tramadol in the last 7 days (ZEST participants should not use Tramadol because of the possibility of an interaction causing the serotonin syndrome)
Anticipated start date 01/05/2002
Anticipated end date 31/12/2006
Status of trial Completed
Patient information material
Target number of participants 450
Interventions Sertraline 50 mg, one tablet once daily by mouth with or without food or identical placebo, one tablet once daily by mouth with or without food.
Primary outcome measure(s) 1. Quality of life (depression, anxiety and fatigue)
2. Survival
3. Adverse events
Secondary outcome measure(s) Not provided at time of registration
Sources of funding 1. New South Wales Cancer Council (Australia)
2. Pfizer - supplied study drug (sertraline and placebo) free of charge
Trial website http://www.ctc.usyd.edu.au/trials/cancer/other_cancer_trials.htm
Publications 2007 results on http://www.ncbi.nlm.nih.gov/pubmed/17548243
Contact name Dr  Martin  Stockler
  Address NHMRC Clinical Trials Centre
University of Sydney
Locked Bag 77
  City/town Camperdown, New South Wales
  Zip/Postcode 1450
  Country Australia
  Tel +61 (0)2 9562 5000
  Fax +61 (0)2 9562 5094
  Email stockler@med.usyd.edu.au
Sponsor National Health and Medical Research Council (NHMRC) Clinical Trials Centre (Australia)
  Address Clinical Trials Centre
University of Sydney
Locked Bag 77
  City/town Camperdown, New South Wales
  Zip/Postcode 1450
  Country Australia
  Tel +61 (0)2 9562 5362
  Fax +61 (0)2 9562 5094
  Email ccarter@ctc.usyd.edu.au
Date applied 22/12/2004
Last edited 10/08/2009
Date ISRCTN assigned 31/03/2005
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