Bipolar Disorder Clinical Trial
— AMINDOfficial title:
AMIloride for the Treatment of Nephrogenic Diabetes Insipidus for Patients With Bipolar Disorder Treated With Lithium: a Randomized Controlled Trial
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.
Status | Recruiting |
Enrollment | 148 |
Est. completion date | November 11, 2025 |
Est. primary completion date | January 11, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - Adults between 18 and 70 years (age = 18 years and <70 years) - Patient with bipolar disorder - Patient treated with lithium for at least 5 years - Patient with a urine concentration defect defined by a maximal urine osmolality < 600 mOsm/kg - Woman of childbearing age agreeing to use an efficient contraceptive method for 12 months Exclusion Criteria: - Renal failure defined as eGFR < 30 ml/min/1.73m² estimated by the CKD-EPI equation - Kalemia > 5 mmol/l - Hypersensitivity or known allergy to amiloride - Hypersensitivity to lactose - Known adrenal insufficiency - Concomitant use of other potassium-sparing treatment (e.g. spironolactone, angiotensin converting enzyme inhibitors (ACE), angiotensin II receptor (AT2R) antagonists, calcineurin inhibitors tacrolimus and ciclosporin) - Acute ongoing infection (less than 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 use in the 6 months prior to randomisation) - Pregnant or breastfeeding women - Participation in another clinical study involving investigational medicinal product or patient being in the exclusion period at the end of a previous study - Patient refusal to participate - Non-affiliation to a social security regimen or CMU - Patient under State Medical Aid - Subject deprived of freedom, subject under a legal protective measure |
Country | Name | City | State |
---|---|---|---|
France | Néphrologie, Hôpital Henri-Mondor | Créteil | |
France | Néphrologie, Hopital Bichat | Paris | |
France | Physiologie Explorations fonctionnelles multidisciplinaires, Hôpital Bichat | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The main objective of this study is demonstrating the efficacy of amiloride to reduce the urine concentration defect in patients treated by lithium and presenting a nephrogenic diabetes insipidus after 2 months of treatment. | The primary endpoint is the percentage change in maximal urine osmolality before and after 2 months of treatment | 2 month after randomization | |
Secondary | Demonstrate the efficacy of amiloride to reduce nocturia | Difference in mean number of nocturnal voids | 2 months after randomization and 12 months after randomization | |
Secondary | Demonstrate the efficacy of amiloride to reduce the sensation of thirst | Difference in mean number of nocturnal voids | 2 months after randomization and 12 months after randomization | |
Secondary | Demonstrate the efficacy of amiloride to reduce polyuria | Presence of polyuria (defined as a daily urine output > 3 L/day) | 2 months after randomization and 12 months after randomization | |
Secondary | Demonstrate the efficacy of amiloride to increase quality of life | Difference in Quality-of-life scale score (SF36) | 2 months after randomization and 12 months after randomization | |
Secondary | Demonstrate the efficacy of amiloride to reduce the decline of eGFR after one year of treatment | Difference in eGFR (estimated by the CKD-EPI equation based on standardized serum creatinine measurement) before and after 12 months of treatment | 12 months after randomization | |
Secondary | Evaluate the effect of amiloride in mood stability | Difference in Mood Scale scores YMRS | 2 months after randomization and 12 months after randomization | |
Secondary | Evaluate the effect of amiloride in circulating lithium levels stability | Difference in residual plasma lithium levels before and after the 2 months treatment period | 2 months after randomization | |
Secondary | Evaluate the effect of amiloride in mood stability | Total number of hospital admission for maniac or depressive relapse during 12 months of treatment | 12 months after randomization | |
Secondary | Evaluate the effect of amiloride in mood stability | Difference in Mood Scale MADRS | 2 months after randomization and 12 months after randomization | |
Secondary | Evaluate the effect of amiloride in mood stability | Difference in anxiety scale score (GAD7) | 2 months after randomization and 12 months after randomization | |
Secondary | Evaluate the effect of amiloride in mood stability | Difference in the Pittsburgh sleep score (PSQI) | 2 months after randomization and 12 months after randomization |
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