Posttraumatic Stress DisorderPhase 4NCT01130103
Combination Treatment for Posttraumatic Stress Disorder (PTSD) After the World Trade Center (WTC) Attack
A Phase 4 study testing Paroxetine and Prolonged Exposure Therapy in people with Posttraumatic Stress Disorder, run by Research Foundation for Mental Hygiene, Inc. at 1 site in United States.
Trial summary
This randomized controlled trial evaluates efficacy of combined prolonged exposure (PE) and the selective serotonin reuptake inhibitor (SSRI) paroxetine in the treatment of survivors of the World Trade Center (WTC) attacks. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- Paroxetine and Prolonged Exposure Therapy
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2004to Feb 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Posttraumatic Stress Disorder, chronic, related to World Trade Center Attacks
- Age 18-70
- CAPS score greater than 45
- Willingness to consent
- For women, negative pregnancy test and using adequate birth control
Who cannot join
- Prominent suicidal ideation
- Current psychotic disorder
- Unstable medical illness
- Women who are pregnant or nursing mothers
- Alcohol or substance use disorder in the past 3 months
- History of seizure disorder
- conditions that contraindicate use of paroxetine
- inability to tolerate a drug free period prior to beginning the study of 4 weeks for MAOIs or fluoxetine and 2 weeks for other psychotropic drugs, except zolpidem for insomnia.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York State Psychiatric Institute
New York, New York, 10032
About this study
Official title: Combination Treatment for PTSD After the WTC Attack
This randomized controlled trial evaluates efficacy of combined prolonged exposure (PE) and the selective serotonin reuptake inhibitor (SSRI) paroxetine in the treatment of survivors of the World Trade Center (WTC) attacks.
Read the detailed description
Selective serotonin reuptake inhibitor (SSRI) medication is often recommended in combination with cognitive behavioral therapies for PTSD, but combined initial treatment of PTSD has not been studied under controlled conditions. Also, there are few studies of either treatment in survivors of terrorism. This randomized controlled trial evaluates efficacy of combined prolonged exposure (PE) and the SSRI paroxetine in the treatment of survivors of the World Trade Center (WTC) attacks.
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- Paroxetine, Prolonged Exposure Therapy
- Keywords
- PTSD, anxiety disorders, trauma
- Medical subject headings
- Stress Disorders, Post-Traumatic, Anxiety Disorders, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParoxetineDrug
Also called Paxil controlled release (CR)
Paroxetine (controlled release) 12.5-50 milligrams (mg) daily for 22 weeks
Prolonged Exposure TherapyBehavioural
Also called Cognitive Behavioral Therapy
Weekly for 10 weeks
| Study group | Role | What they receive |
|---|---|---|
| Paroxetine | Experimental | Paroxetine and Prolonged Exposure Therapy Receives: Drug: Paroxetine; Behavioral: Prolonged Exposure Therapy |
| Placebo pill | Placebo comparator | Placebo pill plus Prolonged Exposure Therapy Receives: Behavioral: Prolonged Exposure Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician Administered PTSD Scale (CAPS)
PTSD severity, minimum = 0 = no symptoms of PTSD maximum = 136 = extremely severe symptoms of PTSD
Measured: Weeks 0,5,10
Number of Participants Who Met Remission Criterion
remission defined as: CAPS less than or equal to 20 and Clinical Global Impression (CGI)-change score=1
Measured: Weeks 5,10
Secondary outcomes (3)
Treatment Response at Weeks 5 and 10
responder status: CGI-change score of 1 or 2
1=very much improved, 2= much improved
Measured: weeks 5,10
Hamilton Depression Scale 0 = no Depression Symptoms 40 = Extreme Depression Symptoms
total score at weeks 0, 5, 10
Measured: weeks 0,5,10
Quality of Life Enjoyment and Satisfaction Scale Total Score at Week 0,5,10
Measures life enjoyment and satisfaction across 16 domains 16 = very poor quality of life to 80 =very good quality of life
Measured: weeks 0,5,10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2010 (estimated)
- Study startMar 2004
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic Stress DisorderStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Research Foundation for Mental Hygiene, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Franklin Schneier, Research Foundation for Mental Hygiene, Inc.
- Investigators
- Franklin Schneier, MD, Principal investigator, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01130103
- Sponsor's protocol ID
- R01MH068173
- Other IDs
- R01MH068173
- Status last verified
- Nov 2012
- First submitted
- 24 May 2010
- Last updated
- 4 Dec 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Schneier FR, Neria Y, Pavlicova M, Hembree E, Suh EJ, Amsel L, Marshall RD. Combined prolonged exposure therapy and paroxetine for PTSD related to the World Trade Center attack: a randomized controlled trial. Am J Psychiatry. 2012 Jan;169(1):80-8. doi: 10.1176/appi.ajp.2011.11020321. Epub 2011 Sep 9.
PubMed 21908494
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination Treatment for PTSD After the WTC Attack
- ClinicalTrials.gov ID
- NCT01130103
- Acronym / sponsor ID
- R01MH068173
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- PTSD, anxiety disorders, trauma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Research Foundation for Mental Hygiene, Inc.University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Mar 2004
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 25 May 2010 (estimated)
- Results
- Posted 14 Aug 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized controlled trial evaluates efficacy of combined prolonged exposure (PE) and the selective serotonin reuptake inhibitor (SSRI) paroxetine in the treatment of survivors of the World Trade Center (WTC) attacks.
Detailed description
Selective serotonin reuptake inhibitor (SSRI) medication is often recommended in combination with cognitive behavioral therapies for PTSD, but combined initial treatment of PTSD has not been studied under controlled conditions. Also, there are few studies of either treatment in survivors of terrorism. This randomized controlled trial evaluates efficacy of combined prolonged exposure (PE) and the SSRI paroxetine in the treatment of survivors of the World Trade Center (WTC) attacks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paroxetine | Experimental | Drug: Paroxetine, Behavioral: Prolonged Exposure TherapyParoxetine and Prolonged Exposure Therapy |
| Placebo pill | Placebo comparator | Behavioral: Prolonged Exposure TherapyPlacebo pill plus Prolonged Exposure Therapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Posttraumatic Stress Disorder, chronic, related to World Trade Center Attacks
- Age 18-70
- CAPS score greater than 45
- Willingness to consent
- For women, negative pregnancy test and using adequate birth control
Key exclusion criteria (8 listed)
- Prominent suicidal ideation
- Current psychotic disorder
- Unstable medical illness
- Women who are pregnant or nursing mothers
- Alcohol or substance use disorder in the past 3 months
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 |
|---|---|---|
| ParoxetineAlso: Paxil controlled release (CR)Paroxetine (controlled release) 12.5-50 milligrams (mg) daily for 22 weeks | Drug | Paroxetine |
| Prolonged Exposure TherapyAlso: Cognitive Behavioral TherapyWeekly for 10 weeks | Behavioural | Paroxetine, Placebo pill |
Primary outcome
Clinician Administered PTSD Scale (CAPS)
Time frame: Weeks 0,5,10
PTSD severity, minimum = 0 = no symptoms of PTSD maximum = 136 = extremely severe symptoms of PTSD
Number of Participants Who Met Remission Criterion
Time frame: Weeks 5,10
remission defined as: CAPS less than or equal to 20 and Clinical Global Impression (CGI)-change score=1
3 secondary outcomes
Treatment Response at Weeks 5 and 10
Time frame: weeks 5,10
Hamilton Depression Scale 0 = no Depression Symptoms 40 = Extreme Depression Symptoms
Time frame: weeks 0,5,10
Quality of Life Enjoyment and Satisfaction Scale Total Score at Week 0,5,10
Time frame: weeks 0,5,10
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21908494Schneier FR, Neria Y, Pavlicova M, Hembree E, Suh EJ, Amsel L, Marshall RD. Combined prolonged exposure therapy and paroxetine for PTSD related to the World Trade Center attack: a randomized controlled trial. Am J Psychiatry. 2012 Jan;169(1):80-8. doi: 10.1176/appi.ajp.2011.11020321. Epub 2011 Sep 9.
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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.
Franklin Schneier, MD principal investigator
New York State Psychiatric Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Paroxetine and Prolonged Exposure Therapy in people with Posttraumatic Stress Disorder, run by Research Foundation for Mental Hygiene, Inc. at 1 site 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 5 inclusion and 8 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: finished, as of the sponsor's last update on 4 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Clinician Administered PTSD Scale (CAPS) (time frame: Weeks 0,5,10). The study lists 2 primary outcomes in all. 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 NCT01130103, 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 4 Dec 2012.