A Retrospective And Multicenter Survey To Investigate The Dosage, Efficacy And Safety Of Sertraline In Posttraumatic Stress Disorder Patients

NCT ID: NCT01607593

Last Updated: 2021-01-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

123 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-08-31

Study Completion Date

2012-10-31

Brief Summary

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This is a multicenter retrospective study to investigate the dosage regimens of sertraline in the treatment of Posttraumatic Stress Disorder (PTSD) under current medical practice and the efficacy and safety of this drug in patients with PTSD. Data will be collected from the medical records of patients with PTSD.

Detailed Description

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Patients with PTSD who have been dosed with sertraline from July 2006 (i.e., the start of marketing of this drug in Japan) or later to before contracting with each investigational site.

Conditions

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Posttraumatic Stress Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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sertraline (Zoloft)

sertraline (Zoloft)

Intervention Type DRUG

Dosage form: Tablet, Dosage: over 25 mg/day, duration: Not defined

Interventions

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sertraline (Zoloft)

Dosage form: Tablet, Dosage: over 25 mg/day, duration: Not defined

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with PTSD who have been dosed with sertraline since July 2006 or later.
* Patients must be Japanese.
* Patients should be started before the conclusion of a contract with each investigational site.

Exclusion Criteria

* Not applicable.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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KURUME University School of Medicine

Kurume, Fukuoka, Japan

Site Status

Hyogo Institute for Traumatic Stress

Chuo-ku,Kobe-city, Hyōgo, Japan

Site Status

National Defense Medical College/Department of Psychiatry

Tokorozawa, Saitama, Japan

Site Status

Institute of Women?s Health Tokyo Women?s Medical University

Shinjyuku-ku, Tokyo, Japan

Site Status

Countries

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Japan

References

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Kamo T, Maeda M, Oe M, Kato H, Shigemura J, Kuribayashi K, Hoshino Y. Dosage, effectiveness, and safety of sertraline treatment for posttraumatic stress disorder in a Japanese clinical setting: a retrospective study. BMC Psychiatry. 2016 Dec 7;16(1):434. doi: 10.1186/s12888-016-1138-5.

Reference Type DERIVED
PMID: 27923359 (View on PubMed)

Related Links

Other Identifiers

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A0501099

Identifier Type: -

Identifier Source: org_study_id

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