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| autoid | 10 |
| crg_id | CRG060500004 |
| titleoftrial | A randomised double blind, placebo controlled, cross-over study of the effect of amiloride over 6 weeks, on renal water handling in individuals with a bipolar or unipolar disorder, requiring lithium therapy |
| acronymnoftrial | Lithium and amiloride therapy |
| website | http:// |
| identificationno | |
| leadprefix | Prof |
| leadsurname | Walker |
| leadgivennames | Robert |
| leadposition | Head of Department and Consultant Nephrologist |
| leaddepartment | Medical & Surgical Sciences |
| leadorganisation | Dunedin School of Medicine, University of Otago |
| leadaddress | PO Box 913 Dunedin, New Zealand |
| leademail | rob.walker@stonebow.otago.ac.nz |
| leadphone | +64 3 4740999 |
| leadfax | +64 3 4747641 |
| leadsuffix | |
| contactprefix | Prof |
| contactsurname | Walker |
| contactgivennames | Robert |
| contactposition | HOD |
| contactdepartment | Medical & Surgical Sciences |
| contactorganisation | Dunedin School of Medicine |
| contactaddress | PO Box 913 Dunedin, New Zealand |
| contactemail | rob.walker@stonebow.otago.ac.nz |
| contactphone | +64 3 47470999 |
| contactfax | +64 3 4747641 |
| funding | govt |
| otherfunding | |
| fundingnameofsponsors | Health Research Council of New Zealand |
| ethicsapproval | yes |
| studytype | randomised |
| studytype_other | |
| groupassignment | crossover |
| blinding_patients | yes |
| blinding_investigators | no |
| blinding_outcomes | yes |
| blinding_analysts | yes |
| proposedstart | May 2005 |
| actualstart | June 2005 |
| proposedcompletiondate | Dec 2006 |
| actualcompletiondate | |
| multi_center_study | yes |
| numberofcentres | 3 |
| multi_national_study | no |
| countrycentres | New Zealand |
| researchquestion | A double blind placebo controlled cross over study to examine the effects of amiloride on lithium-induced changes in urinary concentrating ability and to correlate these changes with urinary aquaporin excretion. The advantage of this design is that each subject will act as their own control, and the stratification problems will be removed. This will enhance the power of the study as well. In the one published study investigating the effects of amiloride on lithium induced diabetes insipidus, by Batlle and colleagues (N Engl J Med 1985), this was an open study of only 9 subjects. They demonstrated an improvement in urinary concentrating ability which was evident by 30 days and persisted for 3 months with ongoing amiloride treatment. Values had returned to baseline by 4 weeks after stopping amiloride. Stuy protocol in brief. Baseline urinary concentrating study ? drug A 6weeks and repeat study ? washout 6weeks and baseline study ? drug B 6 weeks and repeat study. So each participant will undergo 4 overnight fluid deprivation and a dDAVP urinary concentrating ability studies, with measurement of urinary aquaporin excretion. |
| study_status_recruitment | ongoing |
| study_status_recruitment_follow | ongoing |
| healthcarecondition | Lithium induced nephrogenic diabetes insipidus |
| intervention1 | amiloride |
| intervention2 | |
| intervention3 | |
| intervention4 | |
| participants_gender | both |
| participants_other | adults |
| age | minimum age 18 years; maximum age 60 years |
| totalrecruitment | 40 |
| inclusion | Inclusion criteria. All patients aged 18 to 60, with a bipolar or unipolar affective disorder requiring the commencement of lithium to manage their psychiatric disorder, and who are able to give informed consent. |
| exclusion | Exclusion criteria. Any individual who is unable to give informed consent. Any patients with evidence of renal impairment (plasma creatinine > 0.12 mmol/l) Any patient unable to comply with a fluid restriction. Any previous exposure to lithium Pregnancy, thyroid disease. Any contraindication to amiloride. Thiazide or Angiotensin converting enzyme inhibitors, requirement for potassium supplements. |
| primaryoutcomes | Modification of urinary concentrating ability and associated changes in urinary aquaporin excretion. |
| secondaryoutcomes | |
| reference | Bedford JJ, Weggery S, Ellis G, McDonald FJ, Joyce PR, Leader JP, Walker RJ Lithium induced nephrogenic diabetes insipidus: Renal effects of amiloride. Clinical Journal of The American Society of Nephrology: CJASN 2008; 3(5):1342-1331.[edited by GYH Dec 23 2008] |