Post-Traumatic Stress DisorderPhase 4NCT00208130
Topiramate in the Treatment of Posttraumatic Stress Disorder in Civilians
A Phase 4 study testing Topiramate in people with Post-Traumatic Stress Disorder, run by Creighton University at 1 site in United States.
Trial summary
The primary objective of this study is to investigate the safety and efficacy of topiramate in the treatment of PTSD in women survivors of domestic violence and/or rape trauma as measured by the Clinician-Administered PTSD Scale (CAPS) for DSM-IV. Read more about this study
- Who is it for?
- Ages 19 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Post-Traumatic Stress Disorder
- What is being tested?
- Topiramate
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2001to Mar 2004
- Phase
- Phase 4
- 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 19 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects must have a diagnosis of PTSD as defined by DSM-IV for at least six months, supported by the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I).
- Subjects must be female between 19 and 64 years of age, inclusive.
- Subjects must have a minimum past week CAPS score of 50 at Visit 2 (Day 1).
- Subjects must be in generally good health as confirmed by medical history, baseline psychiatric history and physical examination, including vital signs.
- Subjects must have observed the designated washout periods for prohibited medications outlined under the Concomitant Therapy section of this protocol.
- Subjects must have a negative urine drug screening (phencyclidine, cocaine, amphetamines, tetrahydrocannabinol, and opiates) at Visit 1.
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- Subjects must:
- be postmenopausal for at least one year, or
- have had a hysterectomy or tubal ligation or otherwise be incapable of pregnancy, or
- have practiced one of the following methods of contraception for at least one month prior to study entry: hormonal contraceptives, spermicide and barrier, intrauterine device, spousal/partner sterility or
- be practicing abstinence and agree to continue abstinence or to use an acceptable method of contraception (as listed above) should sexual activity commence.
- If (c) or (d), subjects must have a negative urine pregnancy test up to one week prior to Visit 2 (Day 1).
- Subjects must be able to take oral medication, adhere to medication regimens and be willing to return for regular visits.
- Subjects must be able to read and comprehend written instructions and willing to complete all scales and inventories required by this protocol.
Who cannot join
- Subjects who have a DSM-IV diagnosis of substance dependence or abuse (with the exception of nicotine or caffeine dependence) within the past 3 months.
- Subjects with a current or past history of primary major depressive disorder or major anxiety disorder (i.e., panic disorder, obsessive-compulsive disorder, social phobia) as defined by DSM-IV.
- Subjects with a current or lifetime history of schizophrenia, bipolar disorder, or other psychotic disorder as defined by DSM-IV.
- Subjects with a DSM-IV diagnosis of current organic mental disorder, factitious disorder, or malingering.
- Subjects who are currently enrolled in a cognitive-behavioral therapy program.
- Note: Subjects may be receiving concurrent psychotherapy (other than cognitive-behavioral therapy), but subjects must not initiate new psychotherapy treatment during their participation in the trial.
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- Subjects with prior non-response to topiramate for the treatment of PTSD following an adequate trial.
- Subjects with a disability or other compensation claim pending for lack of functioning due to PTSD.
- Subjects with disability compensation dependent on persisting functional impairment related to PTSD.
- Subjects who have previously been treated with topiramate and discontinued treatment due to an adverse event or subjects with a known hypersensitivity to topiramate.
- Subjects with clinically unstable disease: cardiovascular, renal, gastrointestinal, pulmonary, metabolic, endocrine or other systemic disease that could interfere with their participation in the study.
- Subjects with a history of nephrolithiasis.
- Subjects who have SGOT and/or SGPT levels greater than 2 times the upper limit of the normal range at Screening.
- Subjects who have active liver disease.
- Subjects taking antipsychotics within three months of the screening visit.
- Subjects with progressive or degenerative neurologic disorders (e.g., multiple sclerosis).
Trial locations and contacts
1 site in 1 country.
United States1 site
Creighton University Psychiatry and Research Center
Omaha, Nebraska, 68131
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Determine the Efficacy and Safety of Topiramate in the Treatment of Posttraumatic Stress Disorder in Civilians
The primary objective of this study is to investigate the safety and efficacy of topiramate in the treatment of PTSD in women survivors of domestic violence and/or rape trauma as measured by the Clinician-Administered PTSD Scale (CAPS) for DSM-IV.
Read the detailed description
Psychopharmacologic treatment of PTSD has been informed by only limited empirical data. Prior to the recently completed multi-site trials for sertraline conducted by Pearlstein and colleagues which found efficacy for women but not men suffering from chronic PTSD, there were only a handful of published randomized controlled trials. An overview of this literature suggests that tricyclic antidepressants, monoamine inhibitors and selective seratonin reuptake inhibitors (SSRIs) show promise, usually with better responses in civilians with PTSD than in male veterans with combat-related PTSD. Although results from open-label studies of alpha-2 agonists, beta blockers, anticonvulsants, and mood stabilizing agents appear to be promising, at present no one agent has emerged as useful for a broad range of PTSD sufferers.
This is a single-center, outpatient, randomized, double-blind, placebo-controlled, parallel group study designed to evaluate the safety and efficacy of topiramate in treating PTSD in civilian trauma. This study will be conducted in up to 60 subjects with a diagnosis of PTSD as defined by DSM-IV criteria. Thirty subjects will be assigned to topiramate and 30 will be assigned to placebo.
- Conditions
- Post-Traumatic Stress Disorder
- Being tested
- Topiramate
- Keywords
- PTSD, trauma
- Medical subject headings
- Stress Disorders, Post-Traumatic, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TopiramateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy variable for this study will be the change of the 17-item total severity score of the CAPS from baseline to the last visit of Double-Blind Phase.
Secondary outcomes (1)
The secondary efficacy variables consist of changes from baseline to the last visit in Double-Blind Phase of HARS, Ham-D, TOP-8 and CGI at the last visit of Double-Blind Phase.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startOct 2001
- Study completionMar 2004
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 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
- Double blind
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Creighton University
- Sponsor type
- University, hospital or other
- Collaborators
- Ortho-McNeil Janssen Scientific Affairs, LLC
- Investigators
- Frederick Petty, MD, PhD, Principal investigator, Creighton University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00208130
- Sponsor's protocol ID
- CAPSS-201
- Status last verified
- Apr 2009
- First submitted
- 13 Sep 2005
- Last updated
- 29 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Monga V, Petty F, Padala K, Padala PR. Topiramate Monotherapy for Civilian Posttraumatic Stress Disorder: A Controlled Pilot Study. Prim Care Companion CNS Disord. 2023 Oct 19;25(5):23m03555. doi: 10.4088/PCC.23m03555.
PubMed 37857291
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Determine the Efficacy and Safety of Topiramate in the Treatment of Posttraumatic Stress Disorder in Civilians
- ClinicalTrials.gov ID
- NCT00208130
- Acronym / sponsor ID
- CAPSS-201
- Conditions
- Post-Traumatic Stress Disorder
- Keywords
- PTSD, trauma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- Creighton UniversityUniversity, hospital or other
- Collaborators
- Ortho-McNeil Janssen Scientific Affairs, LLC
- Study start
- Oct 2001
- Study completion
- Mar 2004
- First posted
- 21 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 primary objective of this study is to investigate the safety and efficacy of topiramate in the treatment of PTSD in women survivors of domestic violence and/or rape trauma as measured by the Clinician-Administered PTSD Scale (CAPS) for DSM-IV.
Detailed description
Psychopharmacologic treatment of PTSD has been informed by only limited empirical data. Prior to the recently completed multi-site trials for sertraline conducted by Pearlstein and colleagues which found efficacy for women but not men suffering from chronic PTSD, there were only a handful of published randomized controlled trials. An overview of this literature suggests that tricyclic antidepressants, monoamine inhibitors and selective seratonin reuptake inhibitors (SSRIs) show promise, usually with better responses in civilians with PTSD than in male veterans with combat-related PTSD. Although results from open-label studies of alpha-2 agonists, beta blockers, anticonvulsants, and mood stabilizing agents appear to be promising, at present no one agent has emerged as useful for a broad range of PTSD sufferers.
This is a single-center, outpatient, randomized, double-blind, placebo-controlled, parallel group study designed to evaluate the safety and efficacy of topiramate in treating PTSD in civilian trauma. This study will be conducted in up to 60 subjects with a diagnosis of PTSD as defined by DSM-IV criteria. Thirty subjects will be assigned to topiramate and 30 will be assigned to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 19 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Subjects must have a diagnosis of PTSD as defined by DSM-IV for at least six months, supported by the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I).
- Subjects must be female between 19 and 64 years of age, inclusive.
- Subjects must have a minimum past week CAPS score of 50 at Visit 2 (Day 1).
- Subjects must be in generally good health as confirmed by medical history, baseline psychiatric history and physical examination, including vital signs.
- Subjects must have observed the designated washout periods for prohibited medications outlined under the Concomitant Therapy section of this protocol.
Key exclusion criteria (16 listed)
- Subjects who have a DSM-IV diagnosis of substance dependence or abuse (with the exception of nicotine or caffeine dependence) within the past 3 months.
- Subjects with a current or past history of primary major depressive disorder or major anxiety disorder (i.e., panic disorder, obsessive-compulsive disorder, social phobia) as defined by DSM-IV.
- Subjects with a current or lifetime history of schizophrenia, bipolar disorder, or other psychotic disorder as defined by DSM-IV.
- Subjects with a DSM-IV diagnosis of current organic mental disorder, factitious disorder, or malingering.
- Subjects who are currently enrolled in a cognitive-behavioral therapy program.
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 |
|---|---|---|
| Topiramate | Drug | – |
Primary outcome
The primary efficacy variable for this study will be the change of the 17-item total severity score of the CAPS from baseline to the last visit of Double-Blind Phase.
1 secondary outcome
The secondary efficacy variables consist of changes from baseline to the last visit in Double-Blind Phase of HARS, Ham-D, TOP-8 and CGI at the last visit of Double-Blind Phase.
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 29 Apr 2009.
- Derived from this study: PubMed 37857291Monga V, Petty F, Padala K, Padala PR. Topiramate Monotherapy for Civilian Posttraumatic Stress Disorder: A Controlled Pilot Study. Prim Care Companion CNS Disord. 2023 Oct 19;25(5):23m03555. doi: 10.4088/PCC.23m03555.
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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.
Frederick Petty, MD, PhD principal investigator
Creighton University
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 Topiramate in people with Post-Traumatic Stress Disorder, run by Creighton University 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 14 inclusion and 16 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 29 Apr 2009. 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. 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?
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?
The primary efficacy variable for this study will be the change of the 17-item total severity score of the CAPS from baseline to the last visit of Double-Blind Phase.. 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 NCT00208130, 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 Apr 2009.