Official Title: “Special Investigation of Long Term Use of J ZOLOFT”

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.

Study Type: Observational

Study Design: Case-Only, Prospective

Study Primary Completion Date: November 2010

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.

Intervention(s) in this Clinical Trial

• Drug: sertraline hydrochloride
  • J ZOLOFT® Tablets 25 mg and J ZOLOFT® Tablets 50 mg. J ZOLOFT is Brand name in Japan. Dosage, Frequency: According to Japanese LPD, "The usual initial dose of J ZOLOFT in adults is 25 mg daily as sertraline and then gradually increased up to 100 mg, which should be given orally once daily. The dose may be adjusted within the range not exceeding 100mg according to the patient's age and symptoms". Duration: According to the protocol of A0501091, the duration of the investigation for findings regarding safety and efficacy of a patient is from the first drug administration to the 52 weeks after the first administration.

Arms, Groups and Cohorts in this Clinical Trial

• : sertraline hydrochloride.
  • Patients taking sertraline hydrochloride.

Primary Measures

• The incidence of adverse drug reactions.
  • Time Frame: 52 weeks
    Safety Issue?: No
• The number of adverse drug reactions not expected from the LPD (unknown adverse drug reactions).
  • Time Frame: 52 weeks
    Safety Issue?: No
• Factors considered to affect the safety and/or efficacy of this drug.
  • Time Frame: 52 weeks
    Safety Issue?: No

Secondary Measures

• This study is a non-interventional/observational study and does not have any secondary outcomes measures.
  • Time Frame: There are no secondary outcomes for this study
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00605813

Study ID Number: A0501091

ClinicalTrials.gov Identifier: NCT00605813

Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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