Overview

Major Depressive Disorder Study In Adults

Status:
Completed
Trial end date:
2003-09-01
Target enrollment:
0
Participant gender:
All
Summary
A study to obtain safety and tolerability data
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
GlaxoSmithKline
Treatments:
Paroxetine
Serotonin Uptake Inhibitors
Criteria
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.