Depression Study In Elderly Patients

A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Fixed Dose Study Evaluating the Efficacy and Safety of Paroxetine CR in Elderly Outpatients Diagnosed With Major Depressive Disorder

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00067444

Enrollment

560

Registered

2003-08-21

Start date

2003-06-30

Completion date

2005-01-31

Last updated

2016-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depressive Disorder, Major, Major Depressive Disorder (MDD)

Keywords

Elderly, Major Depressive Disorder, MDD

Brief summary

Major Depressive Disorder (MDD) Study in Elderly Outpatients

Interventions

DRUGParoxetine CR

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

60 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Change from baseline to the week 10 last observation carried forward endpoint in the 17-item HAM-D total score.	10 Weeks

Secondary

Measure	Time frame
Mean change from baseline in HAM-D item 1; Mean change from baseline in the CGI severity of illness score at study endpoint; Percentage of patients with HAM-D total score less than or equal to 7.	10 Weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026