Last updated: 11/03/2018 00:31:10
Combination Of PAXIL Tablet And Benzodiazepines
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Post-marketing clinical study on PAXIL Tablet in patients with depression or depressive mood - A study on combination of PAXIL Tablet and benzodiazepines
Trial description: 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).
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Percentage change from baseline in HAM-D
Timeframe: Baseline (Week 0) and Week 8
Extent of change in HAM-D total score
Timeframe: Baseline (Week 0) and Week 8
Secondary outcomes:
Percentage change from Baseline in Self-Reported questionnaire-Depression (SRQ-D)
Timeframe: Up to 8 weeks
Extent of change of SRQ-D
Timeframe: Up to 8 weeks
Number of participants who started tapering benzodiazepine dose and succeeded in tapering
Timeframe: Week 4, 6 and Week 8
Number of participants with success in tapering of Benzodiazepine dose
Timeframe: Week 4, 6 and Week 8
Change from Baseline in Short Form 8 (SF-8) health survey response
Timeframe: Baseline and Week 8
Percentage of responders as per clinical global impression - improvement (CGI-I) and clinical global impression - severity (CGI-S) scale
Timeframe: Week 8
Interventions:
Drug: Paroxetine
Enrollment:
170
Observational study model:
Not applicable
Primary completion date:
2006-08-02
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Mental Disorders
Product
paroxetine
Collaborators
Not applicable
Study date(s)
June 2005 to February 2006
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
18 - 64 years
Accepts healthy volunteers
No
- 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 with a strong suicide tendency.
Inclusion and exclusion criteria
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.
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2006-08-02
Actual study completion date
2006-08-02
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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