Special Investigation Of Long Term Use Of Sertraline.

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

542 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-09-30

Study Completion Date

2011-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Depression Panic Disorder

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Sertraline hydrochloride.

Patients taking Sertraline hydrochloride.

Sertraline hydrochloride

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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J Zoloft, Zoloft

Eligibility Criteria

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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).