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NCT01371474 Clinical Trial

Special Drug Use Investigation for PAXIL Tablet (Investigation in Case of Administered From 20mg/Day)

Panic Disorder Clinical Trial

Official title:
Special Drug Use Investigation for PAXIL Tablet (Investigation in Case of Administered From 20mg/Day)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01371474
Other study ID # 112308
Secondary ID
Status Completed
Phase N/A
First received June 9, 2011
Last updated May 19, 2017
Start date April 2006
Est. completion date June 2008

Study information
Verified date May 2017
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The objective of this survey was to understand the safety and efficacy of PAXIL tablets ("PAXIL", hereinafter) when it was started at 20 mg/day in subjects with depression or in a depressed state.

Recruitment information / eligibility
Status Completed
Enrollment 1483
Est. completion date June 2008
Est. primary completion date March 2008
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Patients with depression or in a depressed state

- Patients who start taking paroxetine at 20mg a day

Exclusion Criteria:

- Patients who have been treated with paroxetine prior to this investigation

- Patients with hypersensitivity to paroxetine

- Patients taking monoamine oxidase inhibitors (MAOIs) or within 2 weeks of stopping treatment with MAOIs

- Concomitant use in patients taking pimozide

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Paroxetine

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
GlaxoSmithKline

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of adverse events Incidence of adverse events in Japanese subjects treated with paroxetine tablet based on prescribing information under the conditions of general clinical practice 12 weeks
Primary Efficacy evaluation based on overall improvement The investigator compared the general condition over 1 week before each clinical visit with that over 1 week before the start of treatment with PAXIL. 12 weeks
Primary Efficacy evaluation based on severity by symptoms At every clinical visit, the investigator rated each of the specified symptoms including depressed mood, loss of interests/concerns, anxiety, lack of motivation, physical symptoms, and sleep disorders. 12 weeks
Primary Efficacy evaluation based on Beck Depression Inventory- Second Edition (BDI-II) The investigator asked each subject to fill out the self-administered form of BDI-II at every clinical visit (recommended clinical visit schedule: 1, 2, 4, 8, and 12 weeks after the start of treatment). 12 weeks
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