A Retrospective And Multicenter Survey To Investigate The Dosage, Efficacy And Safety Of Sertraline In Posttraumatic Stress Disorder Patients
NCT01607593
Last updated date
ABOUT THIS STUDY
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.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
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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
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- 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
- Not applicable.
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Posttraumatic Stress DisorderA Retrospective And Multicenter Survey To Investigate The Dosage, Efficacy And Safety Of Sertraline In Posttraumatic Stress Disorder Patients
NCT01607593
- Kurume-city, Fukuoka
- Chuo-ku,Kobe-city, Hyogo
- Tokorozawa-city, Saitama
- Shinjyuku-ku, Tokyo
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title | A Retrospective And Multicenter Survey To Investigate The Dosage, Efficacy And Safety Of Sertraline In Posttraumatic Stress Disorder Patients | |||
| Official Title | A Retrospective And Multicenter Survey To Investigate The Dosage, Efficacy And Safety Of Sertraline In Posttraumatic Stress Disorder Patients | |||
| 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. | |||
| 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. | |||
| Study Type | Observational | |||
| Study Design | Observational Model: Cohort Time Perspective: Retrospective | |||
| Target Follow-Up Duration | Not Provided | |||
| Biospecimen | Not Provided | |||
| Sampling Method | Non-Probability Sample | |||
| Study Population | Patients with PTSD | |||
| Condition | Posttraumatic Stress Disorder | |||
| Intervention | Drug: sertraline (Zoloft)
Dosage form: Tablet, Dosage: over 25 mg/day, duration: Not defined | |||
| Study Groups/Cohorts | sertraline (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 Status | Completed | |||
| Actual Enrollment | 123 | |||
| Original Estimated Enrollment | 100 | |||
| Actual Study Completion Date | October 2012 | |||
| Actual Primary Completion Date | October 2012 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender |
| |||
| Ages | 18 Years and older (Adult, Older Adult) | |||
| Accepts Healthy Volunteers | No | |||
| Contacts | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries | Japan | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number | NCT01607593 | |||
| Other Study ID Numbers | A0501099 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement | Not Provided | |||
| Responsible Party | Pfizer | |||
| Study Sponsor | Pfizer | |||
| Collaborators | Not Provided | |||
| Investigators |
| |||
| PRS Account | Pfizer | |||
| Verification Date | December 2013 | |||