Special Investigation Of Long Term Use Of Sertraline.

Condition(s) targeted: Depression; Panic Disorder

Intervention: Sertraline hydrochloride (Drug)

Phase: N/A

Status: Completed

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 long time use.

Official title: Special Investigation Of Long Term Use Of J ZOLOFT.

Study design: Observational Model: Case-Only, Time Perspective: Prospective

Primary outcome:

Number of Treatment Related Adverse Events (TRAEs) Not Expected From Japanese Package Insert

Number of Participants of Treatment Related Adverse Events (TRAEs)

Secondary outcome:

Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Renal Dysfunction

Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Past Medical History of Other Illness

Factors Considered to Affect the Efficacy of Sertraline: Non-Pharmaceutical Therapies

Factors Considered to Affect the Efficacy of Sertraline: Present or Past History of Intentional Suicidal Ideation (Including Suicide Attempt)

Detailed description: All the patients for 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
Last updated: August 9, 2012