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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01607593
First received: May 21, 2012
Last updated: December 11, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Posttraumatic Stress Disorder
Drug: sertraline (Zoloft)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Retrospective And Multicenter Survey To Investigate The Dosage, Efficacy And Safety Of Sertraline In Posttraumatic Stress Disorder Patients

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Clinical Global Impression - Improvement (CGI-I) at End of Administration/Observation [ Time Frame: Up to 6 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 123
Study Start Date: August 2012
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
sertraline (Zoloft) Drug: sertraline (Zoloft)
Dosage form: Tablet, Dosage: over 25 mg/day, duration: Not defined
Other Name: sertraline (Zoloft)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with PTSD

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01607593

Locations
Japan
KURUME University School of Medicine
Kurume-city, Fukuoka, Japan
Hyogo Institute for Traumatic Stress
Chuo-ku,Kobe-city, Hyogo, Japan
National Defense Medical College/Department of Psychiatry
Tokorozawa-city, Saitama, Japan
Institute of Women?s Health Tokyo Women?s Medical University
Shinjyuku-ku, Tokyo, Japan
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01607593     History of Changes
Other Study ID Numbers: A0501099
Study First Received: May 21, 2012
Results First Received: September 26, 2013
Last Updated: December 11, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Pfizer:
Retrospective
Sertraline
Posttraumatic stress disorder

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Sertraline
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 18, 2014