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

PHASE4Active, not recruitingINTERVENTIONAL
Enrollment

148

Participants

Timeline

Start Date

January 11, 2023

Primary Completion Date

March 3, 2025

Study Completion Date

January 11, 2026

Conditions
Bipolar Disorder
Interventions
DRUG

Anhydrous Amiloride Hydrochloride

"Amiloride is a blocker of ENaC that is administered patients with various disorders, such as primary or secondary hyperaldosteronism. It does not have the market authorization in the indication of lithium-induced NDI.~Dose : 5 mg Pharmaceutical form: Tablets Daily Posology : 10 mg Route of administration : oral Procedures and duration of treatment: 2 months during the double blinded phase and 10 additional months for the open label phase"

DRUG

Placebo

Route of administration : oral the control arm will receive a placebo twice daily during 2 months

Trial Locations (2)

Unknown

Néphrologie, Hôpital Henri-Mondor, Créteil

Physiologie Explorations fonctionnelles multidisciplinaires, Hôpital Bichat, Paris

All Listed Sponsors
lead

Assistance Publique - Hôpitaux de Paris

OTHER