Post-Traumatic Stress DisorderPhase 2/3NCT00215241
Risperidone Augmentation for PTSD
A Phase 2/3 study testing sertraline and risperidone in people with Post-Traumatic Stress Disorder, run by Duke University at 2 sites in United States.
Trial summary
The purpose of this study is to (1) compare the response of civilians with Posttraumatic Stress Disorder(PTSD) currently receiving sertraline without an optimal response to risperidone augmentation vs. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post-Traumatic Stress Disorder
- What is being tested?
- sertraline and risperidone
- How many people
- 80 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2004to Jul 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
- Signed consent prior to any study procedures being done
- Male or female outpatients between 18-65 years of age
- Trauma experienced meets trauma defined by DSM
- Meets criteria for DSM-IV PTSD as a result of civilian trauma
- CAPS Score of greater than or equal to 50 at screening and baseline
- Able to swallow whole capsules
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- Fluency in both written and spoken English
- Negative urine drug screen at screening visit
- If female of childbearing potential, must have negative serum pregnancy test at screening visit and must agree to use a medically accepted means of contraception throughout the study and for 30 days after completion of the study
- To be include in Phase 2, must complete Phase I and must have less than 70% reduction from baseline on the CAPS
Who cannot join
- Pregnant women or those likely to become pregnant, or nursing mothers
- Medical instability (clinically significant hepatic, cardiac, or pulmonary disease, HIV, uncontrolled hypertension, diabetes or thyroid conditions, seizure disorders, clinically significant laboratory abnormalities at screen
- Primary psychotic disorder, or history of schizophrenia, other psychotic disorder, bipolar disorder, or cognitive disorder
- Those considered a risk for suicidal or homicidal behavior (the clinician will immediately, upon assessing a risk for suicidal or homicidal behavior, refer the patient for further evaluation and probable hospitalization)
- Hypersensitivity or other contraindication to sertraline or risperidone
- Meeting DSM-IV criteria for drug or alcohol dependence within 3 months of study entry
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- Those who are still experiencing an ongoing traumatic stressor (domestic violence/elder abuse) who will need to focus on safety (the clinician will make referrals as appropriate)
- DSM-IV primary diagnosis of any other anxiety disorder or major depressive disorder
- Current use of antipsychotic, or other psychotropic medications, or supplements with known psychotropic effects
- Current involvement in litigation related to PTSD
- Current psychotherapy aimed at treating PTSD
- PTSD as a result of combat-related trauma
- Previous failure to respond to sertraline-risperidone combination at therapeutic dose
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Emory University Medical Center
Atlanta, Georgia, 30322
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Placebo-Controlled Trial of Risperidone Augmentation for SSRI-Resistant Civilian PTSD
The purpose of this study is to (1) compare the response of civilians with Posttraumatic Stress Disorder(PTSD) currently receiving sertraline without an optimal response to risperidone augmentation vs. placebo, and (2) to evaluate the tolerability of risperidone augmentation, and (3) to identifiy predictors of response to risperidone augmentation. the hypothesis is that risperidone augmentation of sertraline treatment of PTSD is safe and effective.
Read the detailed description
This is a multi-center, two-phase study to evaluate the efficacy and safety of risperidone augmentation to sertraline treatment of Post-Traumatic Stress Disorder (PTSD). In the first phase, all patients will be assigned to take open label sertraline for 8 weeks (up to 200 mg/d). Those who have not achieved a significant decrease in their PTSD symptoms by week 8 will be entered into the second phase. In the second phase, patients will continue with the sertraline, but will then be randomly given either risperidone (up to 3 mg/d) or matching placebo in double-blind fashion.
- Conditions
- Post-Traumatic Stress Disorder
- Being tested
- sertraline and risperidone
- Keywords
- PTSD, sertraline, risperidone, antidepressant, antipsychotic, anxiety, 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.
sertraline and risperidoneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician Administered PTSD Scale (CAPS)
Secondary outcomes (6)
Davidson Trauma Scale (DTS)
Beck Depression Inventory
Quality of Life/Q-LES-Q
Connor-Davidson Resilience Scale
Clinical Global Improvement Scale (CGI-I)
Positive and Negative Symptoms Scale (PANSS)
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 startApr 2004
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Traumatic Stress DisorderStudies 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
- 80 participants
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Pharmaceuticals
- Investigators
- Jonathan Davidson, M.D., Principal investigator, Duke UniversityBarbara Rothbaum, Ph.D., Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00215241
- Sponsor's protocol ID
- 5816
- Other IDs
- 5816-05-4R1
- Status last verified
- Jun 2006
- First submitted
- 20 Sep 2005
- Last updated
- 22 Sep 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placebo-Controlled Trial of Risperidone Augmentation for SSRI-Resistant Civilian PTSD
- ClinicalTrials.gov ID
- NCT00215241
- Acronym / sponsor ID
- 5816
- Conditions
- Post-Traumatic Stress Disorder
- Keywords
- PTSD, sertraline, risperidone, antidepressant, antipsychotic, anxiety, trauma
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Janssen Pharmaceuticals
- Study start
- Apr 2004
- Study completion
- Jul 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.
The purpose of this study is to (1) compare the response of civilians with Posttraumatic Stress Disorder(PTSD) currently receiving sertraline without an optimal response to risperidone augmentation vs. placebo, and (2) to evaluate the tolerability of risperidone augmentation, and (3) to identifiy predictors of response to risperidone augmentation. the hypothesis is that risperidone augmentation of sertraline treatment of PTSD is safe and effective.
Detailed description
This is a multi-center, two-phase study to evaluate the efficacy and safety of risperidone augmentation to sertraline treatment of Post-Traumatic Stress Disorder (PTSD). In the first phase, all patients will be assigned to take open label sertraline for 8 weeks (up to 200 mg/d). Those who have not achieved a significant decrease in their PTSD symptoms by week 8 will be entered into the second phase. In the second phase, patients will continue with the sertraline, but will then be randomly given either risperidone (up to 3 mg/d) or matching placebo in double-blind fashion.
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 (10 listed)
- Signed consent prior to any study procedures being done
- Male or female outpatients between 18-65 years of age
- Trauma experienced meets trauma defined by DSM
- Meets criteria for DSM-IV PTSD as a result of civilian trauma
- CAPS Score of greater than or equal to 50 at screening and baseline
Key exclusion criteria (13 listed)
- Pregnant women or those likely to become pregnant, or nursing mothers
- Medical instability (clinically significant hepatic, cardiac, or pulmonary disease, HIV, uncontrolled hypertension, diabetes or thyroid conditions, seizure disorders, clinically significant laboratory abnormalities at screen
- Primary psychotic disorder, or history of schizophrenia, other psychotic disorder, bipolar disorder, or cognitive disorder
- Those considered a risk for suicidal or homicidal behavior (the clinician will immediately, upon assessing a risk for suicidal or homicidal behavior, refer the patient for further evaluation and probable hospitalization)
- Hypersensitivity or other contraindication to sertraline or risperidone
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 |
|---|---|---|
| sertraline and risperidone | Drug | – |
Primary outcome
Clinician Administered PTSD Scale (CAPS)
6 secondary outcomes
Davidson Trauma Scale (DTS)
Beck Depression Inventory
Quality of Life/Q-LES-Q
Connor-Davidson Resilience Scale
Clinical Global Improvement Scale (CGI-I)
Positive and Negative Symptoms Scale (PANSS)
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 22 Sep 2014.
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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
Barbara Rothbaum, Ph.D. principal investigator
Emory University
2 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 sertraline and risperidone in people with Post-Traumatic Stress Disorder, run by Duke University at 2 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 10 inclusion and 13 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 22 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Clinician Administered PTSD Scale (CAPS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Sep 2014; AzTrials last refreshed its copy on 30 Oct 2026.