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

Completed

• Conditions: Posttraumatic Stress Disorder
• Interventions: Drug: sertraline (Zoloft)

• Registration Number: NCT01607593
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2012-05-21
• Study First Submitted QC: 2012-05-24
• Study First Posted: 2012-05-30
• Study Start: 2012-08
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Results First Submitted: 2013-09-26
• Results First Submitted QC: 2013-09-26
• Results First Posted: 2013-12-04
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-25
• Last Update Posted: 2021-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 123

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
sertraline (Zoloft)	sertraline (Zoloft)	-

Primary Outcome Measures

Name	Time	Method
Clinical Global Impression - Improvement (CGI-I) at End of Administration/Observation	Up to 6 years	Number of participants in each category of CGI-I at end of administration/observation. CGI-I is a 7-point clinician-rated scale, ranging from (1) Very much improved, (2)Much improved, (3) Minimally improved, (4) No change, (5) Minimally worse, (6) Much worse, and (7) Very much worse.
Clinical Global Impression of Severity (CGI-S) at Start of Administration/Observation	Start of administration	Number of participants in each category of CGI-S at start and end of administration/observation. CGI-S is a 7-point clinician-rated scale to assess severity of participant's current illness state, ranging from (1)Normal, not ill at all, (2)Borderline mentally ill, (3)Mildly ill, (4)Moderately ill, (5)Markedly ill, (6)Severely ill, (7)Among the most severely ill.
Clinical Global Impression of Severity (CGI-S) at End of Administration/Observation	Up to 6 years	Number of participants in each category of CGI-S at start and end of administration/observation. CGI-S is a 7-point clinician-rated scale to assess severity of participant's current illness state, ranging from (1)Normal, not ill at all, (2)Borderline mentally ill, (3)Mildly ill, (4)Moderately ill, (5)Markedly ill, (6)Severely ill, (7)Among the most severely ill.

Trial Locations

Locations (4)

KURUME University School of Medicine; 🇯🇵 Kurume-city, Fukuoka, Japan

National Defense Medical College/Department of Psychiatry; 🇯🇵 Tokorozawa-city, Saitama, Japan

Hyogo Institute for Traumatic Stress; 🇯🇵 Chuo-ku,Kobe-city, Hyogo, Japan

Institute of Women?s Health Tokyo Women?s Medical University; 🇯🇵 Shinjyuku-ku, Tokyo, Japan