An 8 Week Depression Study In Adults Diagnosed With Major Depressive Disorder

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Major Depressive Disorder (MDD)

Treatments: Drug: Radafaxine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00057239

OHB20001

Details and patient eligibility

About

A Placebo Controlled Study Evaluating Efficacy, Safety and Tolerability of Radafaxine in Patients with Major Depressive Disorder (MDD)

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of Major Depressive Disorder (MDD)
• Duration of current depressive episode 12 weeks - 24 months
• Patients can read and write at a level sufficient to provide a signed consent
• If female, patients must be practicing an acceptable method of birth control

Exclusion criteria

• Patients have other psychiatric disorders that would affect patient's response to treatment
• Patients have not responded to two or more adequate courses of antidepressant therapy
• Patients cannot be currently abusing illicit drugs or alcohol
• Patients are not currently receiving psychotherapy
• Patients have received electroconvulsive therapy within 6 months prior to screening
• Patients are pregnant or lactating

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind