Major Depressive Disorder Clinical Trial
Official title:
Duloxetine for Perimenopausal Depression
Recently, antidepressants have been explored as a class of medications to treat major depression in the context of perimenopause, as well as the somatic symptoms of perimenopause (such as hot flashes). Duloxetine (Cymbalta) is one of the newer antidepressants approved for the treatment of Major Depressive Disorder (MDD). Therefore, the current study is designed to assess the efficacy of duloxetine in a sample of women who are perimenopausal and meet criteria for MDD. We will assess impact on MDD and perimenopausal symptoms.
Over twenty percent of women will experience a major depressive episode in their lifetimes,
a prevalence that reflects a greater risk than is found among men. Perimenopausal
depression, postpartum depression, and unpleasant, disturbing emotional and physical
symptoms that occur just before monthly menstrual periods have been shown to occur during
times of fluctuating levels of estrogen and other gonadal hormones.
Perimenopause is commonly defined as a time of hormonal fluctuation that typically occurs in
women 40-55 years of age with changes in menstrual patterns. It has been demonstrated that
women may be at particularly high risk for depressive symptoms during perimenopause due to
declining levels of estrogen. In a previous study, women at risk for postpartum depression
were found to benefit from estrogen replacement therapy. However, hormone replacement
therapy (HRT) has become increasingly controversial in light of the findings of the Women's
Health Initiative study that determined that women who received estrogen plus progestin were
slightly more likely to suffer from coronary heart disease, strokes, blood clots in the
lungs, and invasive breast cancer. Since the report of these results, HRT use has declined
and as an alternative treatment for depression, antidepressants have been increasingly
utilized for perimenopausal women. Fluoxetine, paroxetine, and venlafaxine are members of a
new class of drugs called selective serotonin reuptake inhibitors (SSRIs) and which have all
been demonstrated to be beneficial in the treatment of hot flashes. Recently, a new
second-generation drug, Duloxetine (Cymbalta), has also been approved for the treatment of
major depression. This drug is a member of a class of compounds that are referred to as
serotonin-norepinephrine reuptake inhibitors (SNRIs). The method by which Duloxetine and
members of this group achieve their effect is similar to that of the other antidepressant
agents that have been used. Recent studies have indicated that Duloxetine appears to provide
relief for both the mood and physical components of perimenopause.
In order to continue studying the benefits of Duloxetine in subjects with perimenopause,
this study is designed to enroll 20 perimenopausal women with depression in a 9-week trial.
Subjects cannot be enrolled in the study if they are currently using hormone replacement
therapy and all patients must meet the criteria for a major depressive episode, which will
be verified by the standardized protocol for establishing depression, the Structured
Clinical Interview for DSM-IV (SCID).
Subjects enrolled in the study, will undergo 7 total clinic visits during a 9-week study
period. The first visit will last approximately 3 hours with all other visits taking
approximately 45 minutes. During the 1st visit, medical and psychiatric history will be
reviewed and blood will be drawn (approximately 3 teaspoons). Blood will be used for routine
laboratory testing. Urine will also be collected for a pregnancy test.
For Major Depressive Disorder, the FDA has recommended that a total dose of 40 mg/day (20 mg
taken twice a day) to 60 mg/day (given either once a day or as 30 mg twice a day) be
administered without regard to meals. While a 120 mg/day dose has been shown to be safe and
effective, there is no evidence that doses higher than 60 mg confer additional significant
benefit, and the higher dose is clearly less well tolerated. During the current study, for a
short period of time participants will receive a placebo (a pill that looks like the study
drug but which does not contain any medication), although during the majority of the study,
participants will be receiving the actual study medication (Duloxetine). The initial dose of
Duloxetine to be given will be a 30 mg dose with the dosage increased over time to 60 mg per
day. This study will be blinded, meaning that participants will not know whether they are
taking placebo or the study drug. However, all subjects will receive duloxetine for the
majority of the time they are enrolled in the trial. Investigators will know when subjects
are receiving the placebo but in order to maintain the blinding of this study, the study
staff will not be able to tell participants when they are taking placebo and when they are
taking Duloxetine.
After the consent forms are read and signed, participants will undergo a Structured Clinical
Interview for DSM-IV (SCID) interview. In addition, symptoms will also be rated by rating
scales that include the Clinical Global Impression (CGI), the Greene Climacteric Scale (GCS)
and the Hamilton Depression Rating Scale (HAM-D (17-item)). To determine functional
assessment in all participants, the Global Assessment Scale (GAF) will be used. All
participants will also undergo an interview that will include a psychiatric and substance
use history (including collection of data regarding the use of alcohol, tobacco, and illicit
substances).
Medical screening will occur in conjunction with the initial entry interview. All patients
must have had a gynecologic exam within the past year and if not, study personnel will
provide a referral for an exam. The investigators will review the patient's medical history.
Laboratory tests will include thyroid function tests (TFTs), liver function tests (LFTs),
renal panel, pregnancy tests, and complete blood count (CBC). Subjects will also complete
the Greene Climacteric Scale, which is used to quantify the severity of perimenopausal
symptoms.
At each of the visits, all participants will be administered the CGI, HAM-D, and GCS
questionnaires/surveys in addition to The Greene Climacteric Scale, which will be used to
quantify symptoms of perimenopause. Also, participants will be asked at each visit if they
have missed any doses during that particular week. Each of the office visits will last
approximately 45 minutes. If necessary, telephone contact with investigators is permissible
and will be available 24 hours/day for emergencies.
Safety and tolerability will be assessed throughout the study. At each study visit,
information on any side effects that may have occurred will be collected. In the rare event
that a side effect or adverse event does occurs, participants will be able to contact any of
the study's research clinicians. Emergency contact personnel will be on-call 24 hours per
day, seven days per week.
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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