AMIND - AMIloride for the treatment of Nephrogenic Diabetes insipidus for patients with bipolar disorder treated with lithium: a randomized controlled trial

Prior treatment

• Previous use of amiloride use in the 6 months prior to randomisation)
• Participation in another clinical study involving investigational medicinal product or patient being in the exclusion period at the end of a previous study
• Acute ongoing infection (less than 3 days before inclusion)
• Rhythm, conduction or repolarisation disorder present on an ECG done within 12 months prior to inclusion

Other illness

• Acute phase of mood disorder
• Uncontrolled diabetes mellitus or diabetes with hyporeninism hypoaldosteronism
• Hypersensitivity or known allergy to amiloride
• Hypersensitivity to lactose
• Known adrenal insufficiency
• Severe heart failure (NYHA > II)

Lab values

• Renal failure defined as eGFR < 30 ml/min/1.73m² estimated by the CKD-EPI equation
• Use of potassium supplements
• Kalemia > 5 mmol/l
• Concomitant use of other potassium-sparing treatment (e.g. spironolactone, angiotensin converting enzyme inhibitors (ACE), angiotensin II receptor (AT2R) antagonists, calcineurin inhibitors tacrolimus and ciclosporin)

Other

• Use of heparins
• Use of trimethoprim
• Cirrhosis
• Oedemas
• Pregnant or breastfeeding women
• Patient refusal to participate
• Non-affiliation to a social security regimen or CMU
• Patient under State Medical Aid
• Subject deprived of freedom, subject under a legal protective measure

• Adults between 18 and 70 years (age ≥ 18 years and <70 years)
• Patient with bipolar disorder
• Patient treated with lithium for at least 5 years
• Patient with a urine concentration defect defined by a maximal urine osmolality < 600 mOsm/kg
• Woman of childbearing age agreeing to use an efficient contraceptive method for 12 months