A Study Of A New Medicine (GW597599B) For The Treatment Of Major Depressive Disorder

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Depressive Disorder, Major

Treatments: Drug: paroxetine; Drug: GW597599B

Study type: Interventional

Funder types: Industry

Identifiers

NCT00048204

NKD20006

Details and patient eligibility

About

A Placebo Controlled Study Evaluating Efficacy And Safety of Medication In Patients With Major Depressive Disorder (MDD)

Enrollment: 372 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients meet the diagnosis of Major Depressive Disorder (MDD).

Exclusion criteria

• Patients with a primary diagnosis other than MDD.
• Patients with a history of schizophrenia, schizoaffective disorders, seizure disorders or bipolar affective disorder.
• Patients receiving formal psychotherapy or cognitive/behavioral therapy concurrently or in the 12 weeks prior to screening visit.
• Patient is actively suicidal.
• Patients who have a history of migraine headaches.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind