Study of Paxil Use in Menopausal Women

Phase

Condition

Menopause

Treatment

N/A

Clinical Study ID

NCT00225914

2004-P-000115

Ages > 40
Female
Accepts Healthy Volunteers

Study Summary

To evaluate the efficacy, safety, and tolerability of Paroxetine treatment in perimenopausal and postmenopausal women who present with menopause-related symptoms after discontinuing hormone therapy (HT), in the presence or absence of concomitant symptoms of depression or anxiety.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Women age 40 and above.
Perimenopausal status (defined as having cycles which vary by more than 7 days fromnormal, or 2 or more skipped cycles and an amenorrheic interval of at least 60 daysbut no more than 12 consecutive months) or postmenopausal status (defined asamenorrheic for 12 or more consecutive months).
Women with prior use of HT for at least two months.
Women who discontinued HT use 1 to 12 months prior to study entry (screening visit).
Women who present with significant menopause-related symptoms (defined as GCS totalscore >20; vasomotor sub-scores >3 and/or ³14 moderate to severe hot flashes perweek), with or without concomitant psychological complaints (symptoms of depressionand/or anxiety).
Women who report physical/emotional symptoms developing or worsening within 3 monthsof HT discontinuation.
General good health.

Exclusion

Exclusion Criteria:

Women who present with moderate-to-severe symptoms of depression (MADRS scores > 19)or anxiety (BAI scores > 19) at baseline.
Women who meet diagnostic criteria at screening visit for a current major Axis Ipsychiatric disorder other than specific phobias (assessed through M.I.N.I.interview). Subjects presenting with symptoms of anxiety or depression, but notmeeting criteria for Depressive Disorders, Bipolar Disorder, Panic Disorder, GAD, OCDor SAD, will be allowed in the study.
Regular treatment with hormonal medications, SSRIs, tricyclic antidepressant, moodstabilizer, oral neuroleptics, sedatives or hypnotics, over-the-counter agents knownto influence hot flushes or mood within 4 weeks prior to screening visit; used ofdepot neuroleptics within 12 weeks prior to screening visit.
Suicidal ideation, homicidal ideation, or psychotic symptoms.
Menstrual dysfunction and amenorrhea of other etiologies.
History of seizure disorder
Pregnancy or breastfeeding.

Study Design

September 01, 2004

September 30, 2006

Study Description

This study is a 10-week double-blinded treatment study of perimenopausal and postmenopausal women who present with menopause-related symptoms after discontinuing Hormone Therapy(HT), with or without concomitant symptoms of depression and anxiety.

The menopausal transition is a period of heightened vulnerability to mood and anxiety disturbances. It is also a period when women may experience significant vasomotor symptoms (i.e. hot flushes and night sweats). More recently, the occurrence of vasomotor symptoms has been associated with increased risk for depression in menopausal women.

The efficacy of estrogens for the treatment of vasomotor symptoms is well established. In addition, the literature support a modulatory effect exerted by estrogen on various neurotransmitter systems that regulate mood and anxiety.

Despite the efficacy of hormone therapy (HT) for the treatment of menopause-related symptoms, a significant number of women discontinue its use during the first year of treatment. Moreover, recent findings from the Women's Health Initiative Study (WHI) have challenged the safety and the benefits that were initially thought to be associated with long-term use of HT. As a result, many women who have been taking HT decided to discontinue the use of HT, which may result in significant changes in their physical well being, quality of life and, possibly, their mental health status. Therefore, the efficacy and tolerability of other interventions such as antidepressants for these sub-populations warrant further investigation.

Treatment with Paroxetine has shown to be efficacious for menopause-related vasomotor symptoms. To date, no studies have examined the extent to which SSRIs may improve physical and psychological symptoms in women who discontinued HT.

Connect with a study center

MGH Center for Perinatal and Women's Mental Health
Boston, Massachusetts 02116
United States
Site Not Available

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