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

PHASE4TerminatedINTERVENTIONAL
Enrollment

85

Participants

Timeline

Start Date

March 28, 2017

Primary Completion Date

September 20, 2019

Study Completion Date

September 20, 2019

Conditions
Bipolar Disorder
Interventions
DRUG

Lithium sulphate prolonged-release 660 mg

Oral administration of one tablet once or twice daily (one tablet in the morning and one tablet in the evening) or two tablets in a single dose (two tablets in the evening) of Lithium sulphate 660 mg (Lithium sulphate dose will be individualised for each patient according to the relevant SmPC). Treatment duration: 3 months.

DRUG

Lithium carbonate immediate-release 150 mg and 300 mg

Oral administration of 300-1800 mg daily divided into 2-6 doses of Lithium carbonate capsules (Lithium carbonate dose will be individualised for each patient according to the relevant SmPC). Treatment duration: 3 months.

Trial Locations (6)

16132

IRCCS Azienda Ospedaliera Universitaria San Martino IST - Clinica Psichiatrica, Genova

24127

Azienda Ospedaliera Papa Giovanni XXIII - Servizio Psichiatrico di Diagnosi e Cura (SPDC 1), Bergamo

53100

Azienda Ospedaliera Universitaria Senese - Dip. Interaziendale di salute mentale - Psichiatria, Siena

56126

Azienda Ospedaliera Universitaria Pisana - Psichiatria 1, Pisa

58016

Ospedale San Giovanni di Dio di Orbetello Unità Funzionale Salute Mentale, Orbetello

00189

Azienda Ospedaliera Sant'Andrea - Dip. Di Neuroscienze, Salute mentale e Organi di senso- NESMOS, Roma

Sponsors
All Listed Sponsors
collaborator

Mediolanum Cardio Research

OTHER

lead

Aziende Chimiche Riunite Angelini Francesco S.p.A

INDUSTRY

NCT03210480 - SALT Study (Switching to the Administration of Lithium Slow -Release Treatment) | Biotech Hunter | Biotech Hunter