Major Depressive Disorder
Conditions
Keywords
Major Depressive Disorder Open-label discontinued
Brief summary
A study to obtain safety and tolerability data
Interventions
DRUGparoxetine CR
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients who prematurely terminated treatment due to treatment emergent adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United States
Outcome results
None listed