Conditions: Depressive Disorder
Keywords: anti-depressant Severe Depression Efficacy Major Depressive Disorder Major Depressive Episode
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 99
Healthy volunteers: no

Brief summary:
The purpose of this study is to test if GSK163090 can reduce the symptoms of depression. The safety and how well the body can handle the drug will also be investigated. The study will be conducted in Russia in hospitalised patients with severe depression. GSK163090 will be compared with placebo, which looks like the study drug but does not contain any active substance. Subjects will be given either the study drug or the matching placebo.

Detailed description:
This is a randomised, multi-centre, double-blind, placebo-controlled, repeat dose, parallel group study in male and female patients with severe depression requiring hospitalization. Efficacy, safety and tolerability will be assessed in three treatment arms. The study will consist of a screening period, a treatment phase (up to 6 weeks) and a post-treatment follow-up visit. The study duration from screening to follow up will be approximately 9 weeks. Subjects who pass screening will be randomized on Day 1 to one of three treatment arms (low dose arm, high dose arm or placebo). Each treatment arm will contain approximately 50 subjects. The subject's depressive symptoms will be assessed using the HAMD17- CR.

Arms:
arm 1: Parallel Group - High Dose Arm, Low Dose Arm arm 2: Parallel Group

Interventions: intervention 1: GSK163090 1 mg intervention 2: GSK163090 Placebo intervention 3: GSK163090 3 mg
Intervention descriptions: intervention 1: Developed for the treatment of Major Depressive Disorder intervention 2: Developed for the treatment of Major Depressive Disorder intervention 3: Developed for the treatment of Major Depressive Disorder

Protocol document: