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AMIloride for the Treatment of Nephrogenic Diabetes Insipidus for Patients With Bipolar Disorder Treated With Lithium

Study acronym: AMIND
StatusActive, Not Recruiting
PhasePhase 4
Started2023-01-11
View on ClinicalTrials.gov ↗

Amendment history

2025-05-06
Study Identification, Study Status, Contacts/Locations v12
Primary completion dateestimated 2025-03-11→confirmed 2025-03-03
Study sites3→2
Study titlerevised
AMIloride for the Treatment of Nephrogenic Diabetes Insipidus for Patients withWith Bipolar Disorder Treated withWith Lithium
2025-01-15
Recruiting→Active, Not Recruiting Study Identification, Study Status, Contacts/Locations v11
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2025-01-11→2025-03-11
Completion date2025-11-11→2026-01-11
Study sitesdetails revised at 3 of 3 sites
Study titlerevised
AMIloride for the Treatment of Nephrogenic Diabetes Insipidus for Patients Withwith Bipolar Disorder Treated Withwith Lithium
2024-02-07
Study Status v10
Primary completion date2024-01-11→2025-01-11
Completion date2024-11-11→2025-11-11
2023-11-28
Study Status, Eligibility v9
Eligibility criteria-1 characters
[...] of trimethoprim Cirrhosis Oedemas Previous use of amiloride (use in the 6 months prior to randomisation) Pregnant or brea [...]
2023-09-01
Study Status, Eligibility v8
Eligibility criteria-32 characters
[...] f trimethoprim Cirrhosis Oedemas Previous use of amiloride (long term use ≥ 6 months or/and use in the 6 months prior to randomisation) Pregnant or brea [...]
Show 7 earlier versions
2023-03-07
Study Status, Contacts/Locations v7
Study sitesdetails revised at 1 of 3 sites
2023-01-16
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v6
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2024-01-01→2024-01-11
Completion date2024-11-01→2024-11-11
Start dateestimated 2023-01-01→confirmed 2023-01-11
Study sites0→3
2022-12-19
Study Status v5
Start date2022-09-01→2023-01-01
2022-05-16
Study Status, Eligibility v4
Start date2022-05-01→2022-09-01
Eligibility criteria-5 characters
[...] s eGFR < 30 ml/min/1.73m² estimated by the CKD-EPI equation HyperkalemiaKalemia > 5 mmol/l Hypersensitivity or known allergy to amiloride H [...]
2022-04-06
Study Status, Eligibility v3
Re-verified, no change to tracked fields
2022-03-28
Study Status, Study Description, Eligibility v2
Start date2022-04-01→2022-05-01
Eligibility criteria+298 characters
Inclusion Criteria: Adults between 18 and 70 years (age ≥ 18 years and <70 years) Patient with bipolar disorder Patient treated with lithium [...] n 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 Acute phase of mood disorder Uncontrolled diabetes mellitus or diabetes with hyporeninism hypoaldosteronism Potassium supplements Use of heparins Use of trimethoprim Cirrhosis Oedemas Previous use of amiloride (long term use ≥ 6 months or/and u [...]
Study description+43 characters
[...] and erythrocyte lithium level, serum osmolality, natremia, kalemiakaliemia, urea, chlore level, complete blood count, plasma copeptine and vasopressin. A nephrologist visit wil [...] These patients will not be included in our study. Otherwise, the treatment is generally safe and well-tolerated. Plasma [...]
2021-11-15
Study Status v1
Start date2021-11-01→2022-04-01
2021-09-09
Original filing
Lithium (Li) is the leading treatment for BD, protecting against both maniac and depressive relapse, and reducing the risk of suicide and mortality. However, despite this major clinical efficacy, the use of lithium is limited by its narrow therapeutic index and by its side effects. Li induces a vasopressin-resistant urinary concentration defect, with resulting nephrogenic diabetes insipidus (NDI) in 12-50 % of patients. This feature is more frequent after 5 years of treatment with lithium. Polyuria and subsequent thirst might affect patients' quality of life, but also cause potentially life-threatening hypernatremia if free access to water is impaired. Thus, we aim at evaluating the efficacy of amiloride on urine concentrating ability in patients with nephrogenic diabetes insipidus due to chronic lithium treatment.
Trial Details
NCT Number NCT05044611
Lead Sponsor Assistance Publique - Hôpitaux de Paris
Conditions Bipolar Disorder
Enrollment 148 participants
Start Date 2023-01-11
Primary Completion 2025-03-03 (estimated)
Study Completion 2026-01-11 (estimated)
Updated on ClinicalTrials.gov 2025-05-09