Major Depressive Disorder Study In Adults

Phase 4CompletedNCT00049972

GlaxoSmithKline646 enrolled

Overview

A study to obtain safety and tolerability data

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

646

Conditions

Major Depressive Disorder

Interventions

paroxetine CRDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient must have primary diagnosis of Major Depressive Disorder (MDD). * Discontinued a selective serotonin reuptake inhibitor (SSRI)or serotonin-norepinephrine reuptake inhibitor (SNRI) regimen due to intolerability. * Minimum time frame between last dose of previous antidepressant and initiation of study drug is one week. * Maximum time frame between last dose of prior antidepressant and initiation of study drug is 2 months. Exclusion Criteria: * Patient has previously been treated with the study drug. * Is experiencing an adverse event attributed to previous SSRI/SNRI use that has not been resolved at least one week prior to Baseline Visit. * Has a history of seizure disorder. * Has met criteria for substance abuse or dependence within 6 months prior to Baseline Visit. * Currently using an antidepressant. * Currently pregnant.

Locations (71)

Outcomes

Primary Outcomes

The proportion of patients who prematurely terminated treatment due to treatment emergent adverse events

Secondary Outcomes

Recurrence rates of adverse events causing intolerability of previous SSRI/SNRI, Adverse event incidence rates, Mean change from baseline in the Beck Depression Inventory-II total score, Proportion of responsers based on teh CGI Global Improvement Item

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.