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

GlaxoSmithKline372 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

372

Conditions

Depressive Disorder, Major

Interventions

GW597599BDRUG

paroxetineDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Hamilton Depression Rating Scale

Time frame: 8 Weeks

Secondary Outcomes

Hamilton Depression Rating Scale Clinical Global Impression-Global Improvement Clinical Global Impression-Severity of Illness Hospital Anxiety and Depression Scale

Time frame: 8 Weeks

Data from ClinicalTrials.gov

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