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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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-515018-42-00
Acronym
APHP200042
Enrollment
148
Registered
2024-08-09
Start date
2023-01-11
Completion date
2026-01-05
Last updated
2024-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients treated with lithium carbonate for a bipolar disorder treated for at least 5 years and with a urine concentration defect.

Brief summary

The primary endpoint is the percentage change in maximal urine osmolality before and after the 2 months treatment period

Detailed description

Percentage change in maximal urine osmolality between baseline (before treatment) and at 6 and 12 months., Self-declared mean number of nocturnal voids before treatment and at 2, 6 and 12 months., Thirst intensity and distress scales score before treatment and at 2, 6 and 12 months., Presence of polyuria (defined as a daily urine output > 3 L/day) after 2, 6, 12 months of treatment, Quality-of-life scale score (SF36) before treatment and at 2, 6 and 12 months., eGFR (estimated by the CKD-EPI equation based on standardized serum creatinine measurement) before treatment and at 2, 6 and 12 months., Mood Scale scores (YMRS and MADRS), anxiety scale score (GAD7) and the Pittsburgh sleep score (PSQI) before treatment and at 2, 6 and 12 months, Total number of hospital admission for maniac or depressive relapse during 12 months of treatment, Difference in residual plasma lithium levels before and after the 2 months treatment period, Short- and long-term tolerances evaluated via Common Terminology Criteria for Adverse Events (CTCAE) with an unacceptable toxicity defined as a grade >= 3 at 2, 6 and 12 months.

Interventions

DRUGPlacebo d'amiloride
DRUGAMILORIDE

Sponsors

Assistance Publique Hopitaux De Paris
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The primary endpoint is the percentage change in maximal urine osmolality before and after the 2 months treatment period

Secondary

MeasureTime frame
Percentage change in maximal urine osmolality between baseline (before treatment) and at 6 and 12 months., Self-declared mean number of nocturnal voids before treatment and at 2, 6 and 12 months., Thirst intensity and distress scales score before treatment and at 2, 6 and 12 months., Presence of polyuria (defined as a daily urine output > 3 L/day) after 2, 6, 12 months of treatment, Quality-of-life scale score (SF36) before treatment and at 2, 6 and 12 months., eGFR (estimated by the CKD-EPI equation based on standardized serum creatinine measurement) before treatment and at 2, 6 and 12 months., Mood Scale scores (YMRS and MADRS), anxiety scale score (GAD7) and the Pittsburgh sleep score (PSQI) before treatment and at 2, 6 and 12 months, Total number of hospital admission for maniac or depressive relapse during 12 months of treatment, Difference in residual plasma lithium levels before and after the 2 months treatment period, Short- and long-term tolerances evaluated via Common Termino

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026