Obsessive-Compulsive DisorderPhase 2/3NCT00299611
Augmentation Study of Levetiracetam in Obsessive Compulsive Disorder
A Phase 2/3 study testing Sertraline and Levetiracetam in people with Obsessive-Compulsive Disorder, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effectiveness of Levetiracetam augmentation relative to Placebo in SSRI non-remitters with obsessive compulsive disorder. The hypothesis is that anxiolytic effect of Levetiracetam is more beneficial when adding with a SSRI. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- Sertraline and Levetiracetam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2005to Apr 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 OCD based on DSM-IV criteria and assessed by the MINI International Neuropsychiatric Interview
- Yale-Brown Obsessive-Compulsive Scale (YBOCS) score of at least 16 or greater on screening
- Ability to provide written consent form
Who cannot join
- Any primary DSM-IV Axis I disorder other than OCD
- Substance abuse during the last 6 months
- A clinically unstable medical condition or clinically significant laboratory abnormalities
- Suicidal risk or serious suicidal attept during the last year
- Concurrent use of psychotropic medication including benzodiazepines, barbituates, 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
Show all 9Show fewer
- Failure of 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, 27710
About this study
Official title: A Double-Blind Augmentation Study of LEvetiracetam in Obsessive Compulsive Disorder
The purpose of this study is to evaluate the effectiveness of Levetiracetam augmentation relative to Placebo in SSRI non-remitters with obsessive compulsive disorder. The hypothesis is that anxiolytic effect of Levetiracetam is more beneficial when adding with a SSRI.
Read the detailed description
This is an investigator-initiated, single-site study, consisting of two phases: 8 weeks of open-label treatment with sertraline (50mg-150mg/day) in patients iwth OCD.At week 8, those who have failed to achieve remission will be continued on sertraline and will be randomized to receive Levetiracetam (500mg-2000mg/day) or Placebo for 8 weeks.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- Sertraline, Levetiracetam, Placebo
- Keywords
- OCD, Anxiety, Pharmacotherapy, Sertraline, Levetiracetam
- Medical subject headings
- Obsessive-Compulsive Disorder, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SertralineDrug
Also called Zoloft
Tablets, 50mg each, (1-3TABLETS/DAY) during the Open-label phase for first 8 wks.
LevetiracetamDrug
Also called Keppra
Tablets, dosage 500mg each tablet (1-4tablets/day)for 8 wks during the 2nd phase of the study.
PlaceboDrug
Tablets, No active ingredient, (1-4tablets/day) for 8 wks during the 2nd phase of the study.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Levetiracetam Receives: Drug: Sertraline; Drug: Levetiracetam |
| 2 | Placebo comparator | there is no active ingredient in the pills. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Global Impression-improvement (CGI-I)
Measured: 24 wks
Secondary outcomes (3)
Yale-Brown Obsessive-Compulsive Scale (YBOCS)
Measured: 24 wks
Hospital Anxiety and Depression Scale
Measured: 24 wks
Sheehan Disability Scale (SDS)
Measured: 24 wks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2006 (estimated)
- Study startNov 2005
- Primary completionDec 2007
- Study completionApr 2008
Why it stopped: Sponsor decided to terminate the study due to budget consideration
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Obsessive-Compulsive 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- UCB Pharma
- Investigators
- Wei Zhang, MD, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00299611
- Sponsor's protocol ID
- Pro00008596
- Status last verified
- Jun 2010
- First submitted
- 6 Mar 2006
- Last updated
- 11 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ellingrod VL. Pharmacotherapy of primary obsessive-compulsive disorder: review of the literature. Pharmacotherapy. 1998 Sep-Oct;18(5):936-60.
PubMed 9758307Sasson Y, Zohar J, Chopra M, Lustig M, Iancu I, Hendler T. Epidemiology of obsessive-compulsive disorder: a world view. J Clin Psychiatry. 1997;58 Suppl 12:7-10.
PubMed 9393390Steketee G. Disability and family burden in obsessive-compulsive disorder. Can J Psychiatry. 1997 Nov;42(9):919-28. doi: 10.1177/070674379704200902.
PubMed 9429061
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind Augmentation Study of LEvetiracetam in Obsessive Compulsive Disorder
- ClinicalTrials.gov ID
- NCT00299611
- Acronym / sponsor ID
- Pro00008596
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- OCD, Anxiety, Pharmacotherapy, Sertraline, Levetiracetam
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decided to terminate the study due to budget consideration
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- UCB Pharma
- Study start
- Nov 2005
- Primary completion
- Dec 2007 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 7 Mar 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 effectiveness of Levetiracetam augmentation relative to Placebo in SSRI non-remitters with obsessive compulsive disorder. The hypothesis is that anxiolytic effect of Levetiracetam is more beneficial when adding with a SSRI.
Detailed description
This is an investigator-initiated, single-site study, consisting of two phases: 8 weeks of open-label treatment with sertraline (50mg-150mg/day) in patients iwth OCD.At week 8, those who have failed to achieve remission will be continued on sertraline and will be randomized to receive Levetiracetam (500mg-2000mg/day) or Placebo for 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Sertraline, Drug: LevetiracetamLevetiracetam |
| 2 | Placebo comparator | Drug: Placebothere is no active ingredient in the pills. |
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 OCD based on DSM-IV criteria and assessed by the MINI International Neuropsychiatric Interview
- Yale-Brown Obsessive-Compulsive Scale (YBOCS) score of at least 16 or greater on screening
- Ability to provide written consent form
Key exclusion criteria (9 listed)
- Any primary DSM-IV Axis I disorder other than OCD
- Substance abuse during the last 6 months
- A clinically unstable medical condition or clinically significant laboratory abnormalities
- Suicidal risk or serious suicidal attept during the last year
- Concurrent use of psychotropic medication including benzodiazepines, barbituates, 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 |
|---|---|---|
| SertralineAlso: ZoloftTablets, 50mg each, (1-3TABLETS/DAY) during the Open-label phase for first 8 wks. | Drug | 1 |
| LevetiracetamAlso: KeppraTablets, dosage 500mg each tablet (1-4tablets/day)for 8 wks during the 2nd phase of the study. | Drug | 1 |
| PlaceboTablets, No active ingredient, (1-4tablets/day) for 8 wks during the 2nd phase of the study. | Drug | 2 |
Primary outcome
Clinical Global Impression-improvement (CGI-I)
Time frame: 24 wks
3 secondary outcomes
Yale-Brown Obsessive-Compulsive Scale (YBOCS)
Time frame: 24 wks
Hospital Anxiety and Depression Scale
Time frame: 24 wks
Sheehan Disability Scale (SDS)
Time frame: 24 wks
Results and safety
The study was stopped early (reason given: Sponsor decided to terminate the study due to budget consideration). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2013.
- Background: PubMed 9758307Ellingrod VL. Pharmacotherapy of primary obsessive-compulsive disorder: review of the literature. Pharmacotherapy. 1998 Sep-Oct;18(5):936-60.
- Background: PubMed 9393390Sasson Y, Zohar J, Chopra M, Lustig M, Iancu I, Hendler T. Epidemiology of obsessive-compulsive disorder: a world view. J Clin Psychiatry. 1997;58 Suppl 12:7-10.
- Background: PubMed 9429061Steketee G. Disability and family burden in obsessive-compulsive disorder. Can J Psychiatry. 1997 Nov;42(9):919-28. doi: 10.1177/070674379704200902.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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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.
Wei Zhang, MD, PhD 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 Sertraline and Levetiracetam in people with Obsessive-Compulsive 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: stopped early, as of the sponsor's last update on 11 Apr 2013. 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 was stopped early (reason given: Sponsor decided to terminate the study due to budget consideration). Results are not available in the source record.
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 Impression-improvement (CGI-I) (time frame: 24 wks). 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 NCT00299611, which also lists 3 linked publications.
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 11 Apr 2013.