Stress Disorders, Post-TraumaticPhase 2/3NCT00215163
Paroxetine-CR to Treat Post-Traumatic Stress Disorder (PTSD) Symptomatic After Initial Exposure Therapy
A Phase 2/3 study testing Cognitive-behavioral therapy and paroxetine-CR in people with Stress Disorders, Post-Traumatic, run by Duke University at 4 sites in United States.
Trial summary
Both pharmacotherapeutic and psychosocial interventions have domenstrated efficacy for PTSD. However, although these interventions can be helpful, many patients remain symptomatic despite initial treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Stress Disorders, Post-Traumatic
- What is being tested?
- Cognitive-behavioral therapy and paroxetine-CR
- How many people
- 17 participants
- Where
- 4 sitesUnited States
- Study dates
- Dec 2002to Jun 2006
- Phase
- Phase 2/3
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female outpatients at least 18 years of age with a primary (the condition that is most central to the patient's current distress) psychiatric diagnosis of PTSD as defined by DSM-IV criteria
- Patients must have remained symptomatic (CGI-S > or = 3) and a score of at least 6 on the SPRINT after a minimum of 7 sessions of prolonged exposure (delivered within 6 weeks) to be eligible for randomized treatment.
Who cannot join
- Serious medical illness or instability for which hospitalization may be likely within the next 3 months
- Pregnant or lactating women or those of childbearing potential not using medically accepted forms of contraception
- Concurrent use of other psychotropic medications
- Lifetime diagnosis of schizophrenia or any other psychotic disorder, mental retardation, organic mental disorders, or bipolar disorder
- Obsessive-Compulsive Disorder, eating disorders, or alcohol/substance abuse disorders within the last 6 months
- A current primary diagnosis of major depression, dysthymia, social anxiety disorder, and generalized anxiety disorder
- A history of hypersensitivity or poor response to paroxetine or those using antidepressants, buspirone, or beta-blockers within 2 weeks of randomization
- Concurrent dynamic or supportive psychotherapy if started within 2 months prior to onset of study entry
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Duke University Medical Center
Durham, North Carolina, 27705
University of Pennsylvania
Philadelphia, Pennsylvania, 19122
University of California at San Diego
San Diego, California, 92093
About this study
Official title: Randomized Trial of Paroxetine-CR for the Treatment of Patients With Post-Traumatic Stress Disorder (PTSD) Remaining Symptomatic After Initial Exposure Therapy
Both pharmacotherapeutic and psychosocial interventions have domenstrated efficacy for PTSD. However, although these interventions can be helpful, many patients remain symptomatic despite initial treatment. In this study, we will examine the relative efficacy of the addition of paroxetine-CR compared to placebo for patients remaining symptomatic despite a brief and intensive course of cognitive-behavioral therapy (CBT).
Read the detailed description
This is a systematic controlled study examining the use of augmentation with pharmaotherapy for PTSD patients remaining symptomatic despite CBT (exposure therapy). The aims of the study include examination of: (1) the efficacy of paroxetine-CR compared to placebo as additions to ongoing exposure therapy in patients who failed to respond to brief, intensive CBT; (2) the tolerability of paroxetine-CR compared to placebo as additions to ongoing exposure therapy in patients who failed to respond to brief, intensive CBT; (3) the outcome of patients at 6 months follow-up to randomized treatment. Patients will initially have intensive (8 sessions over 4 weeks) prolonged exposure therapy. Patients who remain symptomatic will be randomzied to receive either flexibly-dosed paroxetine-CR (12.5 mg/d - 62.5 mg/d) or placebo in conjunction with additional 5 sessions of prolonged exposure over 10 weeks.
- Conditions
- Stress Disorders, Post-Traumatic
- Being tested
- Cognitive-behavioral therapy and paroxetine-CR
- Keywords
- PTSD, Anxiety, CBT, Exposure, Paroxetine, Paroxetine-CR
- Medical subject headings
- Stress Disorders, Post-Traumatic, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-behavioral therapy and paroxetine-CRDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Short PTSD Rating Interview (SPRINT)
Davidson Trauma Scale (DTS)
Secondary outcomes (12)
Clinical Global Impressions Severity Scale (CGI-S)
Clinical Global Impressions Improvement Scale (CGI-I)
Posttraumatic Diagnostic Scale (PDS)
Beck Depression Inventory (BDI)
Quality of Life Enjoyment and Satisfaction Questionnaire/General Activities Subscale (Q-LES-Q/GA)
Sheehan Disability Scale (SDS)
Connor-Davidson Resilience Scale (CD-RISC)
Post-Traumatic Cognitions Inventory (PTCI)
Severity of Symptoms Scale (SOSS)
Pittsburgh Sleep Quality Index (PSQI)
World Assumptions Scale (WAS)
Mood-SR Lifetime
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startDec 2002
- Study completionJun 2006
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.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline, Massachusetts General Hospital
- Responsible party
- Sponsor
- Investigators
- Jonathan Davidson, M.D., Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00215163
- Sponsor's protocol ID
- 4304
- Other IDs
- 4304-02-12
- Status last verified
- Sep 2005
- First submitted
- 20 Sep 2005
- Last updated
- 30 May 2013
- Results posted
- No
Publications
Simon NM, Connor KM, Lang AJ, Rauch S, Krulewicz S, LeBeau RT, Davidson JR, Stein MB, Otto MW, Foa EB, Pollack MH. Paroxetine CR augmentation for posttraumatic stress disorder refractory to prolonged exposure therapy. J Clin Psychiatry. 2008 Mar;69(3):400-5. doi: 10.4088/jcp.v69n0309.
PubMed 18348595
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Paroxetine-CR for the Treatment of Patients With Post-Traumatic Stress Disorder (PTSD) Remaining Symptomatic After Initial Exposure Therapy
- ClinicalTrials.gov ID
- NCT00215163
- Acronym / sponsor ID
- 4304
- Conditions
- Stress Disorders, Post-Traumatic
- Keywords
- PTSD, Anxiety, CBT, Exposure, Paroxetine, Paroxetine-CR
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- GlaxoSmithKline, Massachusetts General Hospital
- Study start
- Dec 2002
- Study completion
- Jun 2006
- First posted
- 22 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.
Both pharmacotherapeutic and psychosocial interventions have domenstrated efficacy for PTSD. However, although these interventions can be helpful, many patients remain symptomatic despite initial treatment. In this study, we will examine the relative efficacy of the addition of paroxetine-CR compared to placebo for patients remaining symptomatic despite a brief and intensive course of cognitive-behavioral therapy (CBT).
Detailed description
This is a systematic controlled study examining the use of augmentation with pharmaotherapy for PTSD patients remaining symptomatic despite CBT (exposure therapy). The aims of the study include examination of: (1) the efficacy of paroxetine-CR compared to placebo as additions to ongoing exposure therapy in patients who failed to respond to brief, intensive CBT; (2) the tolerability of paroxetine-CR compared to placebo as additions to ongoing exposure therapy in patients who failed to respond to brief, intensive CBT; (3) the outcome of patients at 6 months follow-up to randomized treatment. Patients will initially have intensive (8 sessions over 4 weeks) prolonged exposure therapy. Patients who remain symptomatic will be randomzied to receive either flexibly-dosed paroxetine-CR (12.5 mg/d - 62.5 mg/d) or placebo in conjunction with additional 5 sessions of prolonged exposure over 10 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female outpatients at least 18 years of age with a primary (the condition that is most central to the patient's current distress) psychiatric diagnosis of PTSD as defined by DSM-IV criteria
- Patients must have remained symptomatic (CGI-S > or = 3) and a score of at least 6 on the SPRINT after a minimum of 7 sessions of prolonged exposure (delivered within 6 weeks) to be eligible for randomized treatment.
Key exclusion criteria (8 listed)
- Serious medical illness or instability for which hospitalization may be likely within the next 3 months
- Pregnant or lactating women or those of childbearing potential not using medically accepted forms of contraception
- Concurrent use of other psychotropic medications
- Lifetime diagnosis of schizophrenia or any other psychotic disorder, mental retardation, organic mental disorders, or bipolar disorder
- Obsessive-Compulsive Disorder, eating disorders, or alcohol/substance abuse disorders within the last 6 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 |
|---|---|---|
| Cognitive-behavioral therapy and paroxetine-CR | Drug | – |
Primary outcome
Short PTSD Rating Interview (SPRINT)
Davidson Trauma Scale (DTS)
12 secondary outcomes
Clinical Global Impressions Severity Scale (CGI-S)
Clinical Global Impressions Improvement Scale (CGI-I)
Posttraumatic Diagnostic Scale (PDS)
Beck Depression Inventory (BDI)
Quality of Life Enjoyment and Satisfaction Questionnaire/General Activities Subscale (Q-LES-Q/GA)
Sheehan Disability Scale (SDS)
Connor-Davidson Resilience Scale (CD-RISC)
Post-Traumatic Cognitions Inventory (PTCI)
Severity of Symptoms Scale (SOSS)
Pittsburgh Sleep Quality Index (PSQI)
World Assumptions Scale (WAS)
Mood-SR Lifetime
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2013.
- Derived from this study: PubMed 18348595Simon NM, Connor KM, Lang AJ, Rauch S, Krulewicz S, LeBeau RT, Davidson JR, Stein MB, Otto MW, Foa EB, Pollack MH. Paroxetine CR augmentation for posttraumatic stress disorder refractory to prolonged exposure therapy. J Clin Psychiatry. 2008 Mar;69(3):400-5. doi: 10.4088/jcp.v69n0309.
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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.
Jonathan Davidson, M.D. principal investigator
Duke University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Cognitive-behavioral therapy and paroxetine-CR in people with Stress Disorders, Post-Traumatic, run by Duke University at 4 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 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 30 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Short PTSD Rating Interview (SPRINT). 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 NCT00215163, 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 30 May 2013.