Stress Disorders, Post-TraumaticPhase 3NCT00150306
A Ten-Week Study Evaluating The Effectiveness And Safety Of Zoloft In Children And Adolescents With A Diagnosis Of PTSD
A Phase 3 study testing Zoloft (Sertraline) in people with Stress Disorders, Post-Traumatic, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 23 sites in United States.
Trial summary
To evaluate the safety and efficacy of sertraline compared to placebo in children and adolescents (6 to 17 years of age) who are outpatients with Posttraumatic Stress Disorder. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Stress Disorders, Post-Traumatic
- What is being tested?
- Zoloft (Sertraline)
- How many people
- 160 participants
- Where
- 23 sitesUnited States
- Study dates
- Nov 2002to Jul 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subjects must be from 6 to 17 years of age and will have a maximum age of 17 at the Baseline Visit of the study.
- Subjects must have a diagnosis of Posttraumatic Stress Disorder as defined by DSM-IV and determined by the Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL).
Who cannot join
- Subjects whose trauma is ongoing, or who are living in the same home as their abuser, or who are expected to participate in litigation related to their trauma during the course of the study will be excluded from participation.
- Subjects who are likely to or are at high risk for experiencing re-exposure to their index trauma.
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
Pfizer Investigational Site
Baton Rouge, Louisiana, 70816
Pfizer Investigational Site
Bethesda, Maryland, 20814
Pfizer Investigational Site
Charleston, South Carolina, 29425
Pfizer Investigational Site
Cleveland, Ohio, 44106
Pfizer Investigational Site
Gainesville, Florida, 32611
Pfizer Investigational Site
Galveston, Texas, 77555-0188
Pfizer Investigational Site
Houston, Texas, 77058
Pfizer Investigational Site
Indianapolis, Indiana, 46202-5200
Pfizer Investigational Site
Las Vegas, Nevada, 89128
Pfizer Investigational Site
Lebanon, New Hampshire, 03756-0002
Pfizer Investigational Site
Lyndhurst, Ohio, 44124
Pfizer Investigational Site
Manhasset, New York, 11030
Pfizer Investigational Site
New Orleans, Louisiana, 70112
Pfizer Investigational Site
New York, New York, 10016
Pfizer Investigational Site
Overland Park, Kansas, 66214
Pfizer Investigational Site
Plano, Texas, 75024
Pfizer Investigational Site
Sacramento, California, 95817
Pfizer Investigational Site
San Diego, California, 92111
Pfizer Investigational Site
San Marcos, California, 92078
Pfizer Investigational Site
Scottsdale, Arizona, 85281
Pfizer Investigational Site
Stony Brook, New York, 11794
Pfizer Investigational Site
Terre Haute, Indiana, 47802
Pfizer Investigational Site
Washington D.C., District of Columbia, 20010
About this study
Official title: A Multicenter, 10-Week, Randomized, Double-Blind Study Of Sertraline And Placebo In Children And Adolescents With Posttraumatic Stress Disorder (PTSD)
To evaluate the safety and efficacy of sertraline compared to placebo in children and adolescents (6 to 17 years of age) who are outpatients with Posttraumatic Stress Disorder.
Read the detailed description
This study was terminated on July 11, 2007. The results of the primary endpoint analysis at the interim showed that the Zoloft group was not significantly different than the placebo on the primary endpoint and therefore the decision was made to terminate the trial. The decision to terminate the trial was not based on any safety concerns.
- Conditions
- Stress Disorders, Post-Traumatic
- Being tested
- Zoloft (Sertraline)
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zoloft (Sertraline)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy parameter is the University of California at Los Angeles Post-Traumatic Stress Disorder Index for DSM-IV (UCLA PTSD-I).
Secondary outcomes (5)
Secondary efficacy measures include
Child Stress Disorder Checklist (CSDC)
Clinical Global Impression Severity (CGI-S)
Clinical Global Impression Improvement (CGI-I)
Children's Depression Rating Scale - Revised edition (CDRS-R)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
- Study startNov 2002
- Study completionJul 2007
Why it stopped: Please see Detailed Description below for termination reason.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stress Disorders, Post-TraumaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 160 participants
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00150306
- Sponsor's protocol ID
- A0501061
- Status last verified
- Jan 2021
- First submitted
- 6 Sep 2005
- Last updated
- 29 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Robb AS, Cueva JE, Sporn J, Yang R, Vanderburg DG. Sertraline treatment of children and adolescents with posttraumatic stress disorder: a double-blind, placebo-controlled trial. J Child Adolesc Psychopharmacol. 2010 Dec;20(6):463-71. doi: 10.1089/cap.2009.0115.
PubMed 21186964
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, 10-Week, Randomized, Double-Blind Study Of Sertraline And Placebo In Children And Adolescents With Posttraumatic Stress Disorder (PTSD)
- ClinicalTrials.gov ID
- NCT00150306
- Acronym / sponsor ID
- A0501061
- Conditions
- Stress Disorders, Post-Traumatic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Please see Detailed Description below for termination reason.
- Enrolment
- 160 participants
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2002
- Study completion
- Jul 2007 (actual)
- First posted
- 8 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety and efficacy of sertraline compared to placebo in children and adolescents (6 to 17 years of age) who are outpatients with Posttraumatic Stress Disorder.
Detailed description
This study was terminated on July 11, 2007. The results of the primary endpoint analysis at the interim showed that the Zoloft group was not significantly different than the placebo on the primary endpoint and therefore the decision was made to terminate the trial. The decision to terminate the trial was not based on any safety concerns.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Subjects must be from 6 to 17 years of age and will have a maximum age of 17 at the Baseline Visit of the study.
- Subjects must have a diagnosis of Posttraumatic Stress Disorder as defined by DSM-IV and determined by the Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL).
Key exclusion criteria (2 listed)
- Subjects whose trauma is ongoing, or who are living in the same home as their abuser, or who are expected to participate in litigation related to their trauma during the course of the study will be excluded from participation.
- Subjects who are likely to or are at high risk for experiencing re-exposure to their index trauma.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zoloft (Sertraline) | Drug | – |
Primary outcome
The primary efficacy parameter is the University of California at Los Angeles Post-Traumatic Stress Disorder Index for DSM-IV (UCLA PTSD-I).
5 secondary outcomes
Secondary efficacy measures include
Child Stress Disorder Checklist (CSDC)
Clinical Global Impression Severity (CGI-S)
Clinical Global Impression Improvement (CGI-I)
Children's Depression Rating Scale - Revised edition (CDRS-R)
Results and safety
The study was stopped early (reason given: Please see Detailed Description below for termination reason.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2021.
- Derived from this study: PubMed 21186964Robb AS, Cueva JE, Sporn J, Yang R, Vanderburg DG. Sertraline treatment of children and adolescents with posttraumatic stress disorder: a double-blind, placebo-controlled trial. J Child Adolesc Psychopharmacol. 2010 Dec;20(6):463-71. doi: 10.1089/cap.2009.0115.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Zoloft (Sertraline) in people with Stress Disorders, Post-Traumatic, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 23 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Please see Detailed Description below for termination reason.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary efficacy parameter is the University of California at Los Angeles Post-Traumatic Stress Disorder Index for DSM-IV (UCLA PTSD-I).. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00150306, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2021.