drugset / Trial / NCT05044611

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

NCT05044611

Phase 4 Active not recruiting 148 enrolled Assistance Publique - Hôpitaux de Paris
RandomizedSingle-groupQuadruple-blindTreatment

Summary

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.

Timeline

Start
2023-01-11
Primary completion
2025-03-03
Completion
2026-01-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Amiloride Small molecule 5 mg Oral

Indications