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AMIND - AMIloride for the treatment of Nephrogenic Diabetes insipidus for patients with bipolar disorder treated with lithium: a randomized controlled trial
EU CTIS ID: 2024-515018-42-00
What this study is testing
The main objective of this study is demonstrating the efficacy of amiloride to reduce the urine concentration defect in patients treated by lithium and presenting a nephrogenic diabetes insipidus after 2 months of treatment
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- - 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
You likely can't join if
- - Renal failure defined as eGFR < 30 ml/min/1.73m² estimated by the CKD-EPI equation
- - Acute phase of mood disorder
- - Uncontrolled diabetes mellitus or diabetes with hyporeninism hypoaldosteronism
- - Use of potassium supplements
- - Use of heparins
- - Use of trimethoprim
See the full eligibility criteria
- - 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
- - Renal failure defined as eGFR < 30 ml/min/1.73m² estimated by the CKD-EPI equation
- - Acute phase of mood disorder
- - Uncontrolled diabetes mellitus or diabetes with hyporeninism hypoaldosteronism
- - Use of potassium supplements
- - Use of heparins
- - Use of trimethoprim
- - Cirrhosis
- - Oedemas
- - Previous use of amiloride use in the 6 months prior to randomisation)
- - Pregnant or breastfeeding women
- - Participation in another clinical study involving investigational medicinal product or patient being in the exclusion period at the end of a previous study
- - Kalemia > 5 mmol/l
- - 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
- - Hypersensitivity or known allergy to amiloride
- - Hypersensitivity to lactose
- - Known adrenal insufficiency
- - 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)
- - Acute ongoing infection (less than 3 days before inclusion)
- - Severe heart failure (NYHA > II)
- - Rhythm, conduction or repolarisation disorder present on an ECG done within 12 months prior to inclusion
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.