CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 542 enrolled
Drug / intervention
Sertraline hydrochloridedrug
Likely dose
Sertraline hydrochloride 25 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00605813
NCT00605813N/ACompleted
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Special Investigation Of Long Term Use Of J ZOLOFT.

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.·observational·Posted Jan 31, 2008·Updated Jan 28, 2021

In Brief

An observational study evaluating Sertraline hydrochloride for Depression and Panic Disorder. Completed, enrolled 542 participants.

Detailed Summary

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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsDepression, Panic Disorder
Countries--
Collaborators--

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 31, 2008
Enrollment StartSep 1, 2007
Primary CompletionSep 1, 2011
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 18.4 years ago

Interventions

Sertraline hydrochloridedrug

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.