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NCT01607593 Clinical Trial

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

Posttraumatic Stress Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01607593
Other study ID # A0501099
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 2012
Est. completion date October 2012

Study information
Verified date January 2021
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 123
Est. completion date October 2012
Est. primary completion date October 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• sertraline (Zoloft)
Dosage form: Tablet, Dosage: over 25 mg/day, duration: Not defined

Locations
Country Name City State
Japan Hyogo Institute for Traumatic Stress Chuo-ku,Kobe-city Hyogo
Japan KURUME University School of Medicine Kurume-city Fukuoka
Japan Institute of Women?s Health Tokyo Women?s Medical University Shinjyuku-ku Tokyo
Japan National Defense Medical College/Department of Psychiatry Tokorozawa-city Saitama

Sponsors (1)
Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Clinical Global Impression - Improvement (CGI-I) at End of Administration/Observation 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. Up to 6 years
Primary Clinical Global Impression of Severity (CGI-S) at Start of Administration/Observation 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. Start of administration
Primary Clinical Global Impression of Severity (CGI-S) at End of Administration/Observation 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. Up to 6 years
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