Mental Disorders
Conditions
Keywords
depressive episodes, paroxetine, PAXIL, depression, benzodiazepine, combination
Brief summary
This study was designed to assess the efficacy and safety of combination therapy of PAXIL and benzodiazepine anxiolytics. PAXIL Tablet will be administered to patients with depression or depressive episodes who have received Benzodiazepines for at least 4 weeks, and changes in the symptoms of depression will be evaluated by use of the rate and extent of decrease in Hamilton Rating Scale for Depression (HAM-D).
Interventions
DRUGparoxetine
1 or 2 tablets once a day
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Patients with depression or depressive episodes who are diagnosed to have major depressive disorders according to the DSM-IV criteria. * Patients with 14 or higher points in total scores for Items No.1 - 17 on HAM-D. * Patients who have continuously received Benzodiazepine anxiolytics.
Exclusion criteria
* Patients with a strong suicide tendency.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate and extent of decrease in Hamilton Rating Scale for Depression (HAM-D) | 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| The rate and extent of decrease in each item of HAM-D. The rate and extent of decrease of SRQ-D. Percentage of subjects who started tapering Benzodiazepine dose. Success rate in Benzodiazepine tapering Extent increase of SF-8. CGI responder rate. | 8 weeks |
Outcome results
None listed