Premenstrual Dysphoric DisorderpmddNCT00518570
Levetiracetam in the Treatment of Patients With Premenstrual Dysphoric Disorder (PMDD)
A study testing Levetiracetam in people with Premenstrual Dysphoric Disorder, run by Berkshire Health Systems at 1 site in United States.
Trial summary
The purpose of this study is to investigate the clinical efficacy of Levetiracetam in the treatment of symptoms of premenstrual dysphoric disorder (PMDD) in an open label study. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Premenstrual Dysphoric Disorder
- What is being tested?
- Levetiracetam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2003to Oct 2006
- Phase
- Interventional
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- PMDD diagnostic and severity criteria:
- Women with PMDD according to DSM-IV-TR criteria
- At screening by history
- At the end of the Qualification Phase by review of symptom records.
- The first 2 consecutive or 2 out of 3 consecutive qualification cycles must fulfill the following criteria:
- For women who were not on any medications for the PMDD symptoms:
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- Late luteal phase (7 days which include the last six days before menses through day one) daily average of > or equal 3.5 for at least 4 of 7 of these days on any 5 distinct items with no overlap on Daily Record of Severity of Problems (DRSP) Scale, at least one item must represent a non-physical symptom. Entries in the diary must be present for at least three of these days for the item to be used as an inclusion criterion for that month.
- Follicular phase (days 8-12 after first day of menses) daily average less than or equal 2.5 on DRSP scale for non-physical symptoms only. The average will be calculated for days 8-12 of the cycle, day 1 being the first day of menstrual bleeding. Entries in the diary must be present for at least three of these days for the item to be used as an inclusion criterion for that month.
- Late luteal phase (6 days before menses through day 1) daily average at least twice as high as follicular phase daily average for five distinct items.
- Functional impairment questions for late luteal phase require more than or equal to 4 score on at least one item for at least 2 or more days.
- For women who were on anti-depressants or oral contraceptive for at least 2 months:
- Late luteal phase daily average of 2.5 or more for at least 4 of 7 of these days on any 5 distinct items with no overlap on DRSP-scale, at least one item must represent a non-physical symptom. Entries in the diary must be present for at least three of these days for the item to be used as an inclusion criterion for that month.
- Follicular phase daily average 2 or less for each item on DRSP scale for non-physical symptoms only. The average will be calculated for days 8-12 of the cycle, day 1 being the first day of menstrual bleeding. Entries in the diary must be present for at least three of these days for the item to be used as an inclusion criterion for that month.
- Late luteal phase (6 days before menses through day 1 of menses) daily average at least twice as high as follicular phase daily average for three distinct items.
- Functional impairment questions for late luteal phase require 3 or more score on at least one item for 2 or more days.
- Absence of any one of the following Axis I disorders during the last 6 months:
- Major Depressive Disorder
- Anxiety Disorder (Panic Disorder, OCD, PTSD)
- Eating Disorder
- Drug or alcohol abuse
- Absence of any of the following Axis I disorders (current or history of), based on the Mini International Neuropsychiatric interview (MINI)
- Bipolar Disorder
- Psychotic Disorder
- Somatoform Disorder
- Dysthymic Disorder
- Other criteria:
- Age between 18- 50.
- Regular menstrual cycles for the 2-month period preceding enrollment into the Qualification Phase (i.e. menstrual cycle length must be between 21 and 35 days)
- Negative Pregnancy test prior to the Treatment Phase.
- Women must use an effective form of contraception (oral contraceptive, Barrier method, intrauterine devices, tubal ligation are considered effective forms of contraception.)
- Judged to be in good physical health on the basis of medical history, physical examination and laboratory screening.
- Able to understand the procedures and agree to participate in the study by signing the informed consent; in the investigator's opinion, the patient clearly intends to comply with the requirements of the study.
Who cannot join
- Women, who are pregnant, gave birth within the last 8 months, breast-feeding or intending to become pregnant within 6 months.
- Contraindication or hypersensitivity to levetiracetam.
- Ongoing psychotherapy, which has begun <3months prior to the study visit.
- Participation in another clinical trial within the last 3 months prior to the screening visit.
- Known hypersensitivity to Levetiracetam
- Any disease or condition that can compromise the function of body systems and which could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study medication.
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- Severe systemic disease that might interfere with the conduct of the study or the interpretation of the results.
- Uncontrolled thyroid problems.
- Active use of substances, excluding caffeine and nicotine, will not be permitted during the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Berkshire Medical Center, Clinical Trials Program, Department of Psychiatry
Pittsfield, Massachusetts, 01201
About this study
Official title: A Pilot Study: Levetiracetam in the Treatment of Patients With Premenstrual Dysphoric Disorder
The purpose of this study is to investigate the clinical efficacy of Levetiracetam in the treatment of symptoms of premenstrual dysphoric disorder (PMDD) in an open label study.
- Conditions
- Premenstrual Dysphoric Disorder
- Being tested
- Levetiracetam
- Keywords
- PMDD, PMS, Levetiracetam
- Medical subject headings
- Premenstrual Dysphoric Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevetiracetamDrug
Also called Keppra
Levetiracetam was started at 250 mg qhs at the end of the first week of the follicular phase. Dose was gradually increased up to 1500 mg bid as tolerated or clinically effective. The treatment phase lasted 4 months.
| Study group | Role | What they receive |
|---|---|---|
| Open-Label treatment | Experimental | Patients prospectively diagnosed with premenstrual dysphoric disorder. Receives: Drug: Levetiracetam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily Record of Severity of Problems (DRSP), Clinical Global Impression- Severity (CGI-S) and Clinical Global Impression-Improvement (CGI-I).
Measured: 4 months
Secondary outcomes (1)
How Levetiracetam is tolerated, adverse events.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2007 (estimated)
- Study startNov 2003
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premenstrual Dysphoric 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Berkshire Health Systems
- Sponsor type
- University, hospital or other
- Collaborators
- UCB Pharma
- Investigators
- Zerrin E Kayatekin, MD, Principal investigator, Berkshire Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00518570
- Sponsor's protocol ID
- Levetiracetam and PMDD
- Other IDs
- BMC03-010
- Acronym
- pmdd
- Status last verified
- Aug 2007
- First submitted
- 16 Aug 2007
- Last updated
- 20 Aug 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study: Levetiracetam in the Treatment of Patients With Premenstrual Dysphoric Disorder
- ClinicalTrials.gov ID
- NCT00518570
- Acronym / sponsor ID
- pmdd / Levetiracetam and PMDD
- Conditions
- Premenstrual Dysphoric Disorder
- Keywords
- PMDD, PMS, Levetiracetam
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Berkshire Health SystemsUniversity, hospital or other
- Collaborators
- UCB Pharma
- Study start
- Nov 2003
- Study completion
- Oct 2006 (actual)
- First posted
- 20 Aug 2007 (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 investigate the clinical efficacy of Levetiracetam in the treatment of symptoms of premenstrual dysphoric disorder (PMDD) in an open label study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open-Label treatment | Experimental | Drug: LevetiracetamPatients prospectively diagnosed with premenstrual dysphoric disorder. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (32 listed)
- Women with PMDD according to DSM-IV-TR criteria
- The first 2 consecutive or 2 out of 3 consecutive qualification cycles must fulfill the following criteria:
- Absence of any one of the following Axis I disorders during the last 6 months:
- Absence of any of the following Axis I disorders (current or history of), based on the Mini International Neuropsychiatric interview (MINI)
- Age between 18- 50.
Key exclusion criteria (9 listed)
- Women, who are pregnant, gave birth within the last 8 months, breast-feeding or intending to become pregnant within 6 months.
- Contraindication or hypersensitivity to levetiracetam.
- Ongoing psychotherapy, which has begun <3months prior to the study visit.
- Participation in another clinical trial within the last 3 months prior to the screening visit.
- Known hypersensitivity to Levetiracetam
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: KeppraLevetiracetam was started at 250 mg qhs at the end of the first week of the follicular phase. Dose was gradually increased up to 1500 mg bid as tolerated or clinically effective. The treatment phase lasted 4 months. | Drug | Open-Label treatment |
Primary outcome
Daily Record of Severity of Problems (DRSP), Clinical Global Impression- Severity (CGI-S) and Clinical Global Impression-Improvement (CGI-I).
Time frame: 4 months
1 secondary outcome
How Levetiracetam is tolerated, adverse events.
Time frame: 4 months
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 20 Aug 2007.
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Occupational Physicians Facing Premenstrual Dysphoric Disorder: Knowledge, Perceptions and Practices in Occupational Health
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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.
Zerrin E Kayatekin, MD principal investigator
Berkshire Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Levetiracetam in people with Premenstrual Dysphoric Disorder, run by Berkshire Health Systems 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 32 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 20 Aug 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.
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?
Daily Record of Severity of Problems (DRSP), Clinical Global Impression- Severity (CGI-S) and Clinical Global Impression-Improvement (CGI-I). (time frame: 4 months). 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 20 Aug 2007.