N/A
Completed N=122
A Retrospective And Multicenter Survey To Investigate The Dosage, Efficacy And Safety Of Sertraline In Posttraumatic Stress Disorder Patients
Source: ClinicalTrials.gov NCT01607593 ↗Enrolled (actual)
122
Serious AEs
5.7%
Results posted
Dec 2013
Primary outcomePrimary: Clinical Global Impression - Improvement (CGI-I) at End of Administration/Observation — 23; 38; 25; 32 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Global Impression - Improvement (CGI-I) at End of Administration/Observation |
23; 38; 25; 32; 4; 0 | — |
| PRIMARY Clinical Global Impression of Severity (CGI-S) at Start of Administration/Observation |
0; 0; 16; 68; 17; 20 | — |
| PRIMARY Clinical Global Impression of Severity (CGI-S) at End of Administration/Observation |
13; 19; 40; 40; 4; 5 | — |
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.
Data sourced from ClinicalTrials.gov (NCT01607593). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.