Study of Paxil Use in Menopausal Women
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Paroxetine Controlled Release in the Treatment of Symptomatic Menopausal Women Following Discontinuation of Hormone Therapy|
- Mean change from Visit 2 to Visit 4 in the daily hot flash frequency and severity. Response will be considered if ³50% reduction in the hot flash composite score-frequency X severity) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- Proportion of subjects with remission of menopause-related symptoms from Visit 2 to Visit 4 measured by a >50% decrease in Greene Climacteric Scale total and sub-scores and Hot Flush Related Daily Interference Scale (HFRDIS). [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- Occurrence of discontinuation symptoms (DESS- Discontinuation Emergent Signs Symptoms, self-report) at Visit 4. [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
- Proportion of CGI responders (clinician-rated CGI- Improvement 2; Occurrence of adverse events (PRISE-Adverse Event Visit Checklist) throughout the study [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Proportion of subjects with remission of psychological symptoms (MADRS <10; BAI < 11 at Visit 4). [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||September 2004|
|Study Completion Date:||September 2006|
Subjects enter into a six-week, double blind phase, randomized in a 1:1 ratio to paroxetine CR 12.5 mg/day; dosing may be adjusted up to 25 mg/day after two weeks, based on treatment response and tolerability.
Paroxetine CR 12.5 mg/day; dosing may be adjusted up to 25 mg/day after two weeks, based on treatment response and tolerability
Other Name: Paxil
Placebo Comparator: 2
Subjects then enter into a six-week, double blind phase, randomized in a 1:1 ratio to paroxetine CR 12.5 mg/day or matching placebo pill
Subjects enter into a six-week, double blind phase, randomized in a 1:1 ratio to paroxetine CR 12.5 mg/day or matching placebo pill; dosing may be adjusted up to 25 mg/day after two weeks, based on treatment response and tolerability.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00225914
|United States, Massachusetts|
|MGH Center for Perinatal and Women's Mental Health|
|Boston, Massachusetts, United States, 02116|
|Principal Investigator:||Lee S. Cohen, M.D.||MGH Center for Perinatal and Women's Mental Health|