Post-Traumatic Stress DisorderPhase 2/3PTSDNCT00413296
Levetiracetam in Post-Traumatic Stress Disorder
A Phase 2/3 study testing levetiracetam and Levetriracetam in people with Post-Traumatic Stress Disorder, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the short-term efficacy and safety of levetiracetam in post-traumatic stress disorder (PTSD) and to evaluate continuation effects of levetiracetam in preventing PTSD relapse. The hypothesis is that levetiracetam will be safe and effective in preventing relapse of PTSD. 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?
- levetiracetam and Levetriracetam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2005to Mar 2008
- 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
- ages 18-65
- primary diagnosis of PTSD based on DSM-IV criteria and assessed by the MINI International Neuropsychiatric Interview (MINI)
- Davidson Trauma Scale (DTS) score of at least 40 on screening
- ability to provide written informed consent
Who cannot join
- any primary DSM-IV Axis I disorder other than PTSD
- substance abuse during the last 6 months
- a clinically unstable medical condition or clinically significant laboratory abnormalities
- suicide risk or serious suicide attempt during the last year
- concurrent use of psychotropic medications including benzodiazepines, barbiturates, antiepileptic drugs, antidepressants, buspirone, dietary supplements or herbal or homeopathic remedies with psychotropic effects
- recent (within the last 3 months) initiation of cognitive behavioral therapy
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- failure of a previous trial of levetiracetam at 2000 mg/day
- pregnancy or lactation
- women of childbearing potential who are unwilling to practice an acceptable method of contraception
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27705
About this study
Official title: A Double-Blind Discontinuation Study of Levetiracetam in Post- Traumatic Stress Disorder
The purpose of this study is to evaluate the short-term efficacy and safety of levetiracetam in post-traumatic stress disorder (PTSD) and to evaluate continuation effects of levetiracetam in preventing PTSD relapse. The hypothesis is that levetiracetam will be safe and effective in preventing relapse of PTSD.
Read the detailed description
This is an investigator-initiated, single site study, consisting of two phases: 8 weeks of open label treatment with levetiracetam (500-2000 mg/day) in patients with PTSD, and in those who demonstrate at least minimal improvement, 12 weeks of randomized, double-blind treatment with either levetiracetam or matching placebo.
- Conditions
- Post-Traumatic Stress Disorder
- Being tested
- levetiracetam, Placebo, Levetriracetam
- Keywords
- PTSD, Anxiety, Pharmacotherapy, Levetiracetam, Relapse prevention
- 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.
levetiracetamDrug
Also called Keppra
Tablets, dosage 500 mg each ( 1-6 tablets/day)for20 wks
PlaceboDrug
Placebo, Tablets, no active ingredient in the tablets, (1-6tablets/day)for 12 wks in the 2nd phase of the study.
LevetriracetamDrug
Also called Keppra
Tablets, 500 mg each (1-6 tablets/day) for 8 wks during the open label phase and for 12 wks during the 2nd phase of the study.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Tablets, no active ingredient, 1-6 tablets/day for 12 wks in the 2 nd phase of the trial. Receives: Drug: Placebo |
| 2 | Active comparator | Levetiracetam, 500mg (1-6 tablets /day) for 12 wks in the 2nd phase of the study. Receives: Drug: levetiracetam; Drug: Levetriracetam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Global Impressions - Improvement (CGI-I)
Measured: 20 wks
Secondary outcomes (7)
Davidson Trauma Scale (DTS)
Measured: 20 wks
Hospital Anxiety and Depression Scale (HADS)
Measured: 20 wks
Connor-Davidson Resilience Scale (CD-RISC)
Measured: 20 wks
36-item Short Form Health Survey (SF-36)
Measured: 20 wks
Pittsburgh Sleep Quality Index
Measured: 20 wks
Work Productivity and Activity Improvement Questionnaire (WPAI)
Measured: 20 wks
Sheehan Disability Inventory (SDI)
Measured: 20 wks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2006 (estimated)
- Study startNov 2005
- Primary completionSep 2007
- Study completionMar 2008
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
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- UCB Pharma
- Responsible party
- Sponsor
- Investigators
- Jonathan Davidson, M.D., Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00413296
- Sponsor's protocol ID
- Pro00007843
- Other IDs
- 7031-05-4R0
- Acronym
- PTSD
- Status last verified
- Jun 2010
- First submitted
- 18 Dec 2006
- Last updated
- 21 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind Discontinuation Study of Levetiracetam in Post- Traumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT00413296
- Acronym / sponsor ID
- PTSD / Pro00007843
- Conditions
- Post-Traumatic Stress Disorder
- Keywords
- PTSD, Anxiety, Pharmacotherapy, Levetiracetam, Relapse prevention
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- UCB Pharma
- Study start
- Nov 2005
- Primary completion
- Sep 2007 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 19 Dec 2006 (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 evaluate the short-term efficacy and safety of levetiracetam in post-traumatic stress disorder (PTSD) and to evaluate continuation effects of levetiracetam in preventing PTSD relapse. The hypothesis is that levetiracetam will be safe and effective in preventing relapse of PTSD.
Detailed description
This is an investigator-initiated, single site study, consisting of two phases: 8 weeks of open label treatment with levetiracetam (500-2000 mg/day) in patients with PTSD, and in those who demonstrate at least minimal improvement, 12 weeks of randomized, double-blind treatment with either levetiracetam or matching placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: PlaceboTablets, no active ingredient, 1-6 tablets/day for 12 wks in the 2 nd phase of the trial. |
| 2 | Active comparator | Drug: levetiracetam, Drug: LevetriracetamLevetiracetam, 500mg (1-6 tablets /day) for 12 wks in the 2nd phase of the study. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ages 18-65
- primary diagnosis of PTSD based on DSM-IV criteria and assessed by the MINI International Neuropsychiatric Interview (MINI)
- Davidson Trauma Scale (DTS) score of at least 40 on screening
- ability to provide written informed consent
Key exclusion criteria (9 listed)
- any primary DSM-IV Axis I disorder other than PTSD
- substance abuse during the last 6 months
- a clinically unstable medical condition or clinically significant laboratory abnormalities
- suicide risk or serious suicide attempt during the last year
- concurrent use of psychotropic medications including benzodiazepines, barbiturates, antiepileptic drugs, antidepressants, buspirone, dietary supplements or herbal or homeopathic remedies with psychotropic effects
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 |
|---|---|---|
| levetiracetamAlso: KeppraTablets, dosage 500 mg each ( 1-6 tablets/day)for20 wks | Drug | 2 |
| PlaceboPlacebo, Tablets, no active ingredient in the tablets, (1-6tablets/day)for 12 wks in the 2nd phase of the study. | Drug | 1 |
| LevetriracetamAlso: KeppraTablets, 500 mg each (1-6 tablets/day) for 8 wks during the open label phase and for 12 wks during the 2nd phase of the study. | Drug | 2 |
Primary outcome
Clinical Global Impressions - Improvement (CGI-I)
Time frame: 20 wks
7 secondary outcomes
Davidson Trauma Scale (DTS)
Time frame: 20 wks
Hospital Anxiety and Depression Scale (HADS)
Time frame: 20 wks
Connor-Davidson Resilience Scale (CD-RISC)
Time frame: 20 wks
36-item Short Form Health Survey (SF-36)
Time frame: 20 wks
Pittsburgh Sleep Quality Index
Time frame: 20 wks
Work Productivity and Activity Improvement Questionnaire (WPAI)
Time frame: 20 wks
Sheehan Disability Inventory (SDI)
Time frame: 20 wks
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 21 Jul 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
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 levetiracetam and Levetriracetam in people with Post-Traumatic Stress Disorder, run by Duke 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 4 inclusion and 9 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 21 Jul 2014. 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. Some participants in this study may receive a placebo. 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?
Clinical Global Impressions - Improvement (CGI-I) (time frame: 20 wks). 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 21 Jul 2014.