Depression Study In Elderly Patients

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Depressive Disorder, Major; Major Depressive Disorder (MDD)

Treatments: Drug: Paroxetine CR

Study type: Interventional

Funder types: Industry

Identifiers

NCT00067444

29060/874

Details and patient eligibility

About

Major Depressive Disorder (MDD) Study in Elderly Outpatients

Enrollment: 560 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of Major Depressive Disorder (MDD).
• Current major depressive episode at screen at least 2 months duration.
• Must be at least 60 years of age.

Exclusion criteria

• Patients with a primary diagnosis other than MDD.
• Patients with a history of schizophrenia, schizoaffective disorder, bipolar disorder or dementia.
• Patients with a history of brief depressive episodes lasting less than 8 weeks.
• Patients receiving formal psychotherapy within 12 weeks of study.
• Patients who are suicidal.
• Patients who have received electroconvulsive therapy or transcranial magnetic stimulation within 6 months prior to screening.
• Patients with a history or seizure disorders.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind