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

NCT01607593 | Completed Results

• 1 other identifier: A0501099
• Study Type: observational
• Target: 123
• Locations: 1 country
• Sites: 4

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.

Conditions

Posttraumatic Stress Disorder

Keywords

Retrospective; Sertraline; Posttraumatic stress disorder

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (1)

sertraline (Zoloft)

Drug: sertraline (Zoloft)

Interventions

sertraline (Zoloft) DRUG

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

sertraline (Zoloft)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with PTSD

You may qualify if:

• 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.

You may not qualify if:

• Not applicable.

Sponsors & Collaborators

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

Study Sites (4)

KURUME University School of Medicine

Kurume, Fukuoka, Japan

Location

Hyogo Institute for Traumatic Stress

Chuo-ku,Kobe-city, Hyōgo, Japan

Location

National Defense Medical College/Department of Psychiatry

Tokorozawa, Saitama, Japan

Location

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

Shinjyuku-ku, Tokyo, Japan

Location

Related Publications (1)

• 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.

  PMID: 27923359 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Sertraline

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2012
• First Posted: May 30, 2012
• Study Start: August 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: January 27, 2021
• Results First Posted: December 4, 2013

Record last verified: 2021-01

Locations

JP (4)