Comparison of the action of amiloride and thiazide in the reduction of lithium-NDI in patients with affective disorders - Treatment lithium-NDI

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-001202-84-NL

Enrollment

Registered

2007-01-31

Start date

2007-02-01

Completion date

Unknown

Last updated

2021-12-21

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

Conditions

Lithium-induced Nephrogenic Diabetes Insipidus MedDRA version: 9.1 Level: LLT Classification code 10012600 Term: Diabetes insipidus nephrogenic

Interventions

Trade Name: Midamor Product Name: Amiloride Pharmaceutical Form: Capsule* Trade Name: Hydrochloorthiazide Product Name: hydrochloorthiazide Pharmaceutical Form: Capsule*

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Patients treated with lithium for affective disorders -Age above 18 -Having moderate to severe lithium NDI (maximal urinary concentration between 150 and 600 mOsm) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: -Hypo/hyperthyroidism -Hypercalcaemia -Hypokalemia/hyperkalemia -Diabetes mellitus as a cause for the polyuria -Renal insufficiency or underlying renal diseases -Heart rhytm disorders -Systolic blood pressure below 90 mmHg -Treatment with hydrochlorothiazide or amiloride in the preceding 3 months, or treatment with other diuretics on the moment.

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare the effect of amiloride with the effect of hydrochlorothiazide on lithium-NDI, measured as urine volume and maximal urine osmolality;Secondary Objective: To explore the effect of amiloride and thiazide on blood levels of sodium, potassium, chloride, bicarbonate, lithium, creatinine, hemoglobin and osmolality and urine levels of sodium, potassium, urea and creatinine, and osmolality and AQP2. Besides this, vital signs will be measured (bodyweight, blood pressure). Side effects, subjective symptoms and psychiatric outcome will also be recorded.;Primary end point(s): -Maximal urine osmolality -Urine volume (24 hrs)	—

Measure

Time frame

Main Objective: To compare the effect of amiloride with the effect of hydrochlorothiazide on lithium-NDI, measured as urine volume and maximal urine osmolality;Secondary Objective: To explore the effect of amiloride and thiazide on blood levels of sodium, potassium, chloride, bicarbonate, lithium, creatinine, hemoglobin and osmolality and urine levels of sodium, potassium, urea and creatinine, and osmolality and AQP2. Besides this, vital signs will be measured (bodyweight, blood pressure). Side effects, subjective symptoms and psychiatric outcome will also be recorded.;Primary end point(s): -Maximal urine osmolality -Urine volume (24 hrs)

—

Countries

Netherlands

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026