Does amiloride modify the increased urine output that occurs with lithium treatment in individuals with a mood disorder?

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000428066

Acronym

Lithium and amiloride therapy

Enrollment

Registered

2010-05-26

Start date

2007-02-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Patients taking lithium to control their mood disorder are frequently troubled with passing large quantities of urine. A previous study suggested this may be improved by taking amiloride but how this may work is unclear. This study will investigate the actions of amiloride, compared with placebo, to improve the urine concentrating ability, of individuals who are taking lithium.

Interventions

A double blind randomised cross over study of amiloride or placebo on nephrogenic diabetes insipdus in patients on long term lithium therapy. Amiloride or placebo will be initially administered at 5mg tablet per day for the first week and then increased to 10mg (2 tablets) daily if tolerated. Amiloride will be administered for 6 weeks. This is then followed by a 6 week wash out period and the alternate tablet administered.

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

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 criteria

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.

Outcome results