drugset / Trial / NCT03210480
SALT Study (Switching to the Administration of Lithium Slow -Release Treatment)
RandomizedParallel-groupOpen-labelTreatment
Summary
The aim of the study is to assess the tolerability, efficacy and safety of a new lithium sulphate prolonged release formulation (Lithiofor®) in patients affected by Bipolar Disorder poor tolerant to lithium immediate-release treatment in terms of lithium-induced tremor when switched from therapy with a lithium carbonate immediate release formulation (Carbolithium®) to a new lithium sulphate prolonged release formulation (Lithiofor®).
Timeline
- Start
- 2017-03-28
- Primary completion
- 2019-09-20
- Completion
- 2019-09-20
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lithium | Unknown | 660 mg | Oral |
| Comparator | Lithium Carbonate | Unknown | 150 mg | Oral |
| Comparator | Lithium Carbonate | Unknown | 300 mg | Oral |