drugset / Trial / NCT03210480

SALT Study (Switching to the Administration of Lithium Slow -Release Treatment)

NCT03210480

Phase 4 Terminated 85 enrolled Angelini Pharma Mediolanum Cardio Research · collab
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

EvaluationDrugModalityDoseRoute
Subject Lithium Unknown 660 mg Oral
Comparator Lithium Carbonate Unknown 150 mg Oral
Comparator Lithium Carbonate Unknown 300 mg Oral

Indications