Major Depressive Disorder Study In Adults

Phase 4

Completed

• Conditions: Major Depressive Disorder

• Registration Number: NCT00049972
• Lead Sponsor: GlaxoSmithKline

Brief Summary

A study to obtain safety and tolerability data

Detailed Description

Not available

Study Timeline

• Study Start: 2002-09
• Study First Submitted: 2002-11-18
• Study First Submitted QC: 2002-11-18
• Study First Posted: 2002-11-19
• Primary Completion: 2003-09
• Study Completion: 2003-09
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-08
• Last Update Posted: 2017-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 646

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

GSK Clinical Trial Call Center; 🇺🇸 Kirkland, Washington, United States