Patients treated with lithium carbonate for a bipolar disorder treated for at least 5 years and with a urine concentration defect.
Conditions
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
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the percentage change in maximal urine osmolality before and after the 2 months treatment period | — |
Secondary
| Measure | Time 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