WHO ICTRP trial

Lurasidone - A 24-week Extension Study of Patients With Bipolar I Depression

CTRI/2009/091/000752 · Clinical Trials Registry India (CTRI) · Not Recruiting

Key facts

Trial ID CTRI/2009/091/000752
Public title Lurasidone - A 24-week Extension Study of Patients With Bipolar I Depression
Scientific title A 24-Week, Flexible-Dose, Open-label Extension Study of Lurasidone for the Treatment of Bipolar I Depression.
Primary sponsor Sunovion Pharmaceuticals Inc
Registry Clinical Trials Registry India (CTRI)
Recruitment status Not Recruiting
Study type Interventional
Phase Phase 3
Countries India;Czech Republic;France;Germany;Poland;Romania;Russian Federation;South Africa;Ukraine;United States of America
Conditions Health Condition 1: null- Bipolar I depression Health Condition 2: F318- Other bipolar disorders
Interventions Intervention1: lurasidone: Lurasidone 20, 40, 60, 80, 100 or 120 mg/day, orally, once daily in the evening, with a meal or within 30 minutes after eating, for 6 weeks. Lurasidone dosing will be initiated at 20 mg/day for Days 1-3 and 40…
Registration date Oct 14, 2009
Target size 460
Secondary IDs D1050256;NCT00868959
Registry page ctri.nic.in

At a glance

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