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.
Inclusion Criteria:
PMDD diagnostic and severity criteria:
1. 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.
2. 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:
- 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.
3. 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
4. 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:
1. Age between 18- 50.
2. 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)
3. Negative Pregnancy test prior to the Treatment Phase.
4. Women must use an effective form of contraception (oral contraceptive, Barrier method,
intrauterine devices, tubal ligation are considered effective forms of
contraception.)
5. Judged to be in good physical health on the basis of medical history, physical
examination and laboratory screening.
6. 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.
Exclusion Criteria:
1. Women, who are pregnant, gave birth within the last 8 months, breast-feeding or
intending to become pregnant within 6 months.
2. Contraindication or hypersensitivity to levetiracetam.
3. Ongoing psychotherapy, which has begun <3months prior to the study visit.
4. Participation in another clinical trial within the last 3 months prior to the
screening visit.
5. Known hypersensitivity to Levetiracetam
6. 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.
7. Severe systemic disease that might interfere with the conduct of the study or the
interpretation of the results.
8. Uncontrolled thyroid problems.
9. Active use of substances, excluding caffeine and nicotine, will not be permitted
during the study.
