Special Investigation of Long Term Use of Sertraline

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

Special investigation of long term use of sertraline, 52 Week Observation, Long-Term Safety.

The objective of this "Special investigation" 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 regarding to long time use.

Official title: Special Investigation of Long Term Use of J ZOLOFT

Study design: Case-Only, Prospective

Primary outcome:

The incidence of adverse drug reactions.

The number of adverse drug reactions not expected from the LPD (unknown adverse drug reactions).

Factors considered to affect the safety and/or efficacy of this drug.

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.

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- The patients who take sertraline hydrochloride for longer than the duration of 16

weeks among the patients enrolled in A0501090 (Drug Use Investigation of J Zoloft).

Exclusion Criteria:

- Patients not taking sertraline hydrochloride.

To obtain contact information for a study center near you, click here.

Starting date: September 2007
Ending date: November 2010
Last updated: February 4, 2008