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

Last updated on November 13, 2019

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Study Location
KURUME University School of Medicine
Kurume-city, Fukuoka, Japan
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Posttraumatic Stress Disorder
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
NCT01607593
Pfizer
Completed
A Retrospective And Multicenter Survey To Investigate The Dosage, Efficacy And Safety Of Sertraline In Posttraumatic Stress Disorder Patients

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Descriptive Information
Brief TitleA Retrospective And Multicenter Survey To Investigate The Dosage, Efficacy And Safety Of Sertraline In Posttraumatic Stress Disorder Patients
Official TitleA Retrospective And Multicenter Survey To Investigate The Dosage, Efficacy And Safety Of Sertraline In Posttraumatic Stress Disorder Patients
Brief SummaryThis 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 DescriptionPatients 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 TypeObservational
Study DesignObservational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study PopulationPatients with PTSD
ConditionPosttraumatic Stress Disorder
InterventionDrug: sertraline (Zoloft)
Dosage form: Tablet, Dosage: over 25 mg/day, duration: Not defined
Study Groups/Cohortssertraline (Zoloft)
Intervention: Drug: sertraline (Zoloft)
Publications *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.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment StatusCompleted
Actual Enrollment
 (submitted: December 10, 2012)
123
Original Estimated Enrollment
 (submitted: May 24, 2012)
100
Actual Study Completion DateOctober 2012
Actual Primary Completion DateOctober 2012   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study:All
Ages18 Years and older   (Adult, Older Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesJapan
Removed Location Countries  
 
Administrative Information
NCT NumberNCT01607593
Other Study ID NumbersA0501099
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateDecember 2013

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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