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

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.

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Key information

Conditions

Posttraumatic Stress Disorder Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

KURUME University School of Medicine, Kurume, Fukuoka, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

sertraline (Zoloft)

Drug

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

Primary outcomes

Clinical Global Impression - Improvement (CGI-I) at End of Administration/Observation

Time frame: 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

Time frame: 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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Important dates

Study start: 2012
Primary completion: 2012
Study completion: 2012
First posted: May 30, 2012
Registry last updated: Jan 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed