Posttraumatic Stress DisorderPhase 2/3NCT00204386
Safety & Efficacy Study Using Topiramate in Posttraumatic Stress Disorder
A Phase 2/3 study testing Topiramate in people with Posttraumatic Stress Disorder, run by University of Oklahoma at 1 site in United States.
Trial summary
The purpose of this study was to determine if Topiramate was safe and effective for use in civilian subjects with Posttraumatic Stress Disorder. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- Topiramate
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2002to May 2007
- 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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- PTSD as defined by DSM-IV for at least 6 months supported by the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I);
- Subjects must have a minimum past week CAPS score of > than 50 at Visit 2;
- Subjects must be in general good health as confirmed by medical history, and physical examination;
- Subjects must be off prohibited medications for washout periods as outlined under Concomitant Therapy section;
- Subjects must have negative urine drug screen (phencyclidine, cocaine, amphetamines, tetrahydrocannabinol, and opiates) at visit 1;
- Subjects must either be postmenopausal for at least 1 year,have had a hysterectomy or tubal ligation, be otherwise incapable of pregnancy or have practiced one of the following methods of contraception for at least one month prior to enrollment: 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.
- Subjects must be able to take oral medication, adhere to medication regiments and be willing to return for regular visits;
- After full explanation of the study, subjects must demonstrate their willingness to participate by signing an informed consent form.
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 current or past history of primary major depressive disorder or primary major anxiety disorder (i.e. panic disorder, obsessive-compulsive disorder, social phobia) as defined by DSM-IV;
- Subjects with current or lifetime history of schizophrenia, bipolar disorder, or other psychotic disorder;
- Subjects with diagnosis of current organic mental disorder, factitious disorder or malingering
- Subjects with diagnosis of bulimia or anorexia nervosa;
- Subjects who are currently enrolled in cognitive-behavioral therapy;
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- Subjects with current disability compensation or claim pending for persisting functional impairment related to PTSD;
- Subjects with prior non-response to topiramate for the treatment of PTSD following an adequate trial.
- 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 history of nephrolithiasis;
- Subjects with SGOT and/or SGPT levels greater than 2 times the upper limit of normal range at screening;
- Subjects taking antipsychotics within 3 months of the screening visit;
- Subjects with progressive or degenerative neurologic disorders (e.g. multiple sclerosis);
- Subjects with active liver disease;
- Subjects with estimated creatinine clearance < 60 mL/min;
- Subjects with known clinically significant medical conditions, including but not limited to: symptomatic coronary artery or peripheral vascular disease, malignancy within the past 5 years, except basal cell carcinoma; any condition compromising the function of those body systems that could result in altered absorption, excess accumulation or impaired metabolism or excretion of topiramate; subjects with history of attempted suicide/homicide in the past 12 months or suicidal/homicidal tendencies or judged clinically to be at serious suicidal/homicidal risk;
- Subjects who are pregnant or lactating;
- Subjects who have not observed the designated washout periods for any of the prohibited medications outline in this protocol;
- Subjects who in the opinion of the investigator should not be enrolled in the study because of the Precautions, Warnings, or Contraindications of the topiramate package insert.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
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
The purpose of this study was to determine if Topiramate was safe and effective for use in civilian subjects with Posttraumatic Stress Disorder.
Read the detailed description
Civilian PTSD is a widespread psychiatric condition and is commonly underestimated in terms of prevalence and morbidity, at least in the United States and probably world-wide. The magnitude of the public health impact of PTSD is highlighted by recent epidemiologic findings. Kessler, et al, estimated a 7.8% lifetime prevalence for PTSD in a representative national sample of 5877 persons aged 15-54. In part, this high prevalence is due to the high occurrence of trauma exposure over a lifetime. Common types of Civilian PTSD include serious physical attack or assault, rape, sexual assault, transportation accidents, exposure to death/homicide or serious injury, life-threatening accidents, threats of injury with fire, floods, weapons, natural disasters and civilian exposure to military attacks. Persons with PTSD are usually unaware that they have this disorder and because treatment professionals have been inadequately sensitized to high prevalence of this condition, the condition is markedly undiagnosed and thereby undertreated. The risk of PTSD is not restricted to the psychiatric population. In general, persons with PTSD seek help in general medical and not mental health settings. Individuals with PTSD are at increased risk of co-morbid psychiatric disorders including depression, alcohol and drug abuse, panic disorder, agoraphobia and personality disorders. It is associated with a substantially higher suicide risk, hospitalization rates, and increased utilization rates of non-psychiatric medical services as well as mental health services.
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- Topiramate
- Keywords
- Posttraumatic Stress Disorder
- 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.
TopiramateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Total CAPS Scale Score change from baseline/visit 2. CAPS administered at 5,7 and 9
Measured: 12 weeks
Secondary outcomes (1)
CGI Scale at visit 2 through 9; HARS at visit 2,4,5,7 and 9; HAM-D at visit 2,4,5,7 and 9; DTS at visits 2,4,5,7 and 9; TOP 8 at visits 2, 4-9; SDS visits 2-9; SVS visits 2-9
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startSep 2002
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- Ortho-McNeil Neurologics, Inc.
- Investigators
- Phebe M Tucker, MD, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00204386
- Sponsor's protocol ID
- CAPSS-205
- Other IDs
- IRB#10198
- Status last verified
- May 2007
- First submitted
- 12 Sep 2005
- Last updated
- 30 May 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2007. 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
- ClinicalTrials.gov ID
- NCT00204386
- Acronym / sponsor ID
- CAPSS-205
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- Posttraumatic Stress Disorder
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- Ortho-McNeil Neurologics, Inc.
- Study start
- Sep 2002
- Study completion
- May 2007 (actual)
- First posted
- 20 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 was to determine if Topiramate was safe and effective for use in civilian subjects with Posttraumatic Stress Disorder.
Detailed description
Civilian PTSD is a widespread psychiatric condition and is commonly underestimated in terms of prevalence and morbidity, at least in the United States and probably world-wide. The magnitude of the public health impact of PTSD is highlighted by recent epidemiologic findings. Kessler, et al, estimated a 7.8% lifetime prevalence for PTSD in a representative national sample of 5877 persons aged 15-54. In part, this high prevalence is due to the high occurrence of trauma exposure over a lifetime. Common types of Civilian PTSD include serious physical attack or assault, rape, sexual assault, transportation accidents, exposure to death/homicide or serious injury, life-threatening accidents, threats of injury with fire, floods, weapons, natural disasters and civilian exposure to military attacks. Persons with PTSD are usually unaware that they have this disorder and because treatment professionals have been inadequately sensitized to high prevalence of this condition, the condition is markedly undiagnosed and thereby undertreated. The risk of PTSD is not restricted to the psychiatric population. In general, persons with PTSD seek help in general medical and not mental health settings. Individuals with PTSD are at increased risk of co-morbid psychiatric disorders including depression, alcohol and drug abuse, panic disorder, agoraphobia and personality disorders. It is associated with a substantially higher suicide risk, hospitalization rates, and increased utilization rates of non-psychiatric medical services as well as mental health services.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- PTSD as defined by DSM-IV for at least 6 months supported by the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I);
- Subjects must have a minimum past week CAPS score of > than 50 at Visit 2;
- Subjects must be in general good health as confirmed by medical history, and physical examination;
- Subjects must be off prohibited medications for washout periods as outlined under Concomitant Therapy section;
- Subjects must have negative urine drug screen (phencyclidine, cocaine, amphetamines, tetrahydrocannabinol, and opiates) at visit 1;
Key exclusion criteria (20 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 current or past history of primary major depressive disorder or primary major anxiety disorder (i.e. panic disorder, obsessive-compulsive disorder, social phobia) as defined by DSM-IV;
- Subjects with current or lifetime history of schizophrenia, bipolar disorder, or other psychotic disorder;
- Subjects with diagnosis of current organic mental disorder, factitious disorder or malingering
- Subjects with diagnosis of bulimia or anorexia nervosa;
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
Total CAPS Scale Score change from baseline/visit 2. CAPS administered at 5,7 and 9
Time frame: 12 weeks
1 secondary outcome
CGI Scale at visit 2 through 9; HARS at visit 2,4,5,7 and 9; HAM-D at visit 2,4,5,7 and 9; DTS at visits 2,4,5,7 and 9; TOP 8 at visits 2, 4-9; SDS visits 2-9; SVS visits 2-9
Time frame: 12 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 30 May 2007.
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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.
Phebe M Tucker, MD principal investigator
Professor
1 site 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 Topiramate in people with Posttraumatic Stress Disorder, run by University of Oklahoma 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 8 inclusion and 20 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 2007. 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 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?
Total CAPS Scale Score change from baseline/visit 2. CAPS administered at 5,7 and 9 (time frame: 12 weeks). 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 30 May 2007.