Drug Use Investigation of Jzoloft
Information source: Pfizer
Information obtained from ClinicalTrials.gov on June 20, 2008 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Depression; Panic Disorder
Intervention: Sertraline hydrochloride (Drug)
Phase: Phase 4
Status: Enrolling by invitation
Sponsored by: Pfizer Official(s) and/or principal investigator(s): Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Summary
The objective of this surveillance is to collect information about 1) adverse drug reactions
not expected from the LPD (unknown adverse drug reactions), 2) the incidence of adverse drug
reactions in this surveillance, and 3) factors considered to affect the safety and/or
efficacy of this drug.
Clinical Details
Official title: Drug Use Investigation of Jzoloft
Study design: Case-Only, Prospective
Primary outcome: Factors considered to affect the safety and/or efficacy of this drug.The incidence of adverse drug reactions. The number of adverse drug reactions not expected from the LPD (unknown adverse drug reactions).
Secondary outcome: This study is a non-interventional/observational study and does not have any secondary outcomes measures.
Detailed description:
All the patients whom an investigator prescribes the first Sertraline hydrochloride should be
registered consecutively until the number of subjects reaches target number in order to
extract patients enrolled into the investigation at random.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients need to be taking Sertraline hydrochloride in order to be enrolled in the
surveillance.
Exclusion Criteria:
- Patients not taking Sertraline hydrochloride.
Locations and Contacts
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: April 2007
Ending date: November 2010
Last updated: February 4, 2008
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