Post-Traumatic Stress DisordersPhase 1/2NCT00133822
Civilian Post-Traumatic Stress Disorder Risperidone Clinical Trial
A Phase 1/2 study testing Sertraline and Risperidone in people with Post-Traumatic Stress Disorders, run by Emory University at 3 sites in United States.
Trial summary
The purpose of this study is to determine whether the administration of risperidone is effective in the treatment of selective serotonin reuptake inhibitor (SSRI)-resistant post-traumatic stress disorder (PTSD) in civilians. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Post-Traumatic Stress Disorders
- What is being tested?
- Sertraline and Risperidone
- How many people
- 65 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2004to Sep 2006
- Phase
- Phase 1/2
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Meets criteria for DSM-IV PTSD for a minimum of one month duration
- Clinician-Administered PTSD Scale (CAPS) score > or = to 50
- Able to read and complete questionnaires and interviews
- Negative urine drug screen
Who cannot join
- Pregnant or nursing
- Primary psychotic disorder; psychotic disorder; or cognitive disorder.
- Prominent suicidal or homicidal ideation
- Alcohol or substance dependence within 3 months of starting study
- Primary anxiety disorder or bipolar disorder
- Patients currently being treated with antipsychotic medication
- Patients in active psychotherapy aimed at PTSD
- Combat-related PTSD
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Emory University School of Medicine
Atlanta, Georgia, 30322
Medical University of South Carolina
Charleston, South Carolina
Duke University Medical Center South
Durham, North Carolina, 27710
About this study
Official title: Placebo-Controlled Trial of Risperidone Augmentation for SSRI-Resistant Civilian PTSD
The purpose of this study is to determine whether the administration of risperidone is effective in the treatment of selective serotonin reuptake inhibitor (SSRI)-resistant post-traumatic stress disorder (PTSD) in civilians.
Read the detailed description
Individuals with PTSD often experience anxiety attacks, nightmares, or repeated unwanted memories after experiencing or witnessing life-threatening events, such as serious accidents or natural disasters, or traumatic events such as physical or sexual abuse.
Risperidone has been approved by the Food and Drug Administration for the treatment of psychotic disorders and has been found helpful for PTSD and depression, but is still considered investigational for the purposes of this study.
All qualified participants will be started on sertraline (Zoloft) for eight weeks. Patients who are still symptomatic at the end of this phase, will be invited to join the second portion of the study where they will be randomly assigned to receive risperidone or placebo (sugar pill) in addition to the sertraline. Participants will be monitored regularly for medication effects, adverse events, and PTSD symptoms.
- Conditions
- Post-Traumatic Stress Disorders
- Being tested
- Sertraline and Risperidone
- Keywords
- Post-Traumatic Stress Disorder, Sertraline, Risperidone
- 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.
Sertraline and RisperidoneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Remission of symptoms after 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2005 (estimated)
- Study startApr 2004
- Primary completionSep 2006
- Study completionSep 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 Post-Traumatic Stress DisordersStudies of the same condition, open and under way.
- More trials run by Emory 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 65 participants
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen, LP
- Responsible party
- Principal investigator, Barbara O. Rothbaum, PhD, Emory University
- Investigators
- Barbara O Rothbaum, PHD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00133822
- Sponsor's protocol ID
- 0184-2004
- Other IDs
- RIS-EMR-4005
- Status last verified
- Aug 2015
- First submitted
- 22 Aug 2005
- Last updated
- 19 Aug 2015
- Results posted
- No
Publications
Rothbaum BO, Killeen TK, Davidson JR, Brady KT, Connor KM, Heekin MH. Placebo-controlled trial of risperidone augmentation for selective serotonin reuptake inhibitor-resistant civilian posttraumatic stress disorder. J Clin Psychiatry. 2008 Apr;69(4):520-5. doi: 10.4088/jcp.v69n0402.
PubMed 18278987
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2015. 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
- NCT00133822
- Acronym / sponsor ID
- 0184-2004
- Conditions
- Post-Traumatic Stress Disorders
- Keywords
- Post-Traumatic Stress Disorder, Sertraline, Risperidone
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Janssen, LP
- Study start
- Apr 2004
- Primary completion
- Sep 2006 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 24 Aug 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 determine whether the administration of risperidone is effective in the treatment of selective serotonin reuptake inhibitor (SSRI)-resistant post-traumatic stress disorder (PTSD) in civilians.
Detailed description
Individuals with PTSD often experience anxiety attacks, nightmares, or repeated unwanted memories after experiencing or witnessing life-threatening events, such as serious accidents or natural disasters, or traumatic events such as physical or sexual abuse.
Risperidone has been approved by the Food and Drug Administration for the treatment of psychotic disorders and has been found helpful for PTSD and depression, but is still considered investigational for the purposes of this study.
All qualified participants will be started on sertraline (Zoloft) for eight weeks. Patients who are still symptomatic at the end of this phase, will be invited to join the second portion of the study where they will be randomly assigned to receive risperidone or placebo (sugar pill) in addition to the sertraline. Participants will be monitored regularly for medication effects, adverse events, and PTSD symptoms.
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
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Meets criteria for DSM-IV PTSD for a minimum of one month duration
- Clinician-Administered PTSD Scale (CAPS) score > or = to 50
- Able to read and complete questionnaires and interviews
- Negative urine drug screen
Key exclusion criteria (8 listed)
- Pregnant or nursing
- Primary psychotic disorder; psychotic disorder; or cognitive disorder.
- Prominent suicidal or homicidal ideation
- Alcohol or substance dependence within 3 months of starting study
- Primary anxiety disorder or bipolar disorder
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
Remission of symptoms after 16 weeks
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 19 Aug 2015.
- Derived from this study: PubMed 18278987Rothbaum BO, Killeen TK, Davidson JR, Brady KT, Connor KM, Heekin MH. Placebo-controlled trial of risperidone augmentation for selective serotonin reuptake inhibitor-resistant civilian posttraumatic stress disorder. J Clin Psychiatry. 2008 Apr;69(4):520-5. doi: 10.4088/jcp.v69n0402.
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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.
Barbara O Rothbaum, PHD principal investigator
Emory University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Sertraline and Risperidone in people with Post-Traumatic Stress Disorders, run by Emory University at 3 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 4 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 19 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Remission of symptoms after 16 weeks. 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 NCT00133822, 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 19 Aug 2015.