Study of Paxil Use in Menopausal Women

NCT00225914 | Completed Phase 4

• 1 other identifier: 2004-P-000115
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Menopause

Keywords

Menopause; Hormone Therapy; Paxil; Hot Flash; Sleep Disturbance; Night Sweats; Antidepressants

Outcome Measures

Primary Outcomes (1)

• 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)

  6 weeks

Secondary Outcomes (4)

• 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).

  6 weeks

• Occurrence of discontinuation symptoms (DESS- Discontinuation Emergent Signs Symptoms, self-report) at Visit 4.

  6 weeks

• Proportion of CGI responders (clinician-rated CGI- Improvement 2; Occurrence of adverse events (PRISE-Adverse Event Visit Checklist) throughout the study

  8 weeks

• Proportion of subjects with remission of psychological symptoms (MADRS <10; BAI < 11 at Visit 4).

  6 weeks

Study Arms (2)

1

EXPERIMENTAL

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.

Drug: Paroxetine

2

PLACEBO COMPARATOR

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

Drug: placebo

Interventions

Paroxetine DRUG

Paroxetine CR 12.5 mg/day; dosing may be adjusted up to 25 mg/day after two weeks, based on treatment response and tolerability

Also known as: Paxil

1

placebo DRUG

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.

2

Eligibility Criteria

• Age: 40 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women age 40 and above.
• Perimenopausal status (defined as having cycles which vary by more than 7 days from normal, or 2 or more skipped cycles and an amenorrheic interval of at least 60 days but no more than 12 consecutive months) or postmenopausal status (defined as amenorrheic 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 total score \>20; vasomotor sub-scores \>3 and/or ³14 moderate to severe hot flashes per week), with or without concomitant psychological complaints (symptoms of depression and/or anxiety).
• Women who report physical/emotional symptoms developing or worsening within 3 months of HT discontinuation.
• General good health.

You may not qualify if:

• 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 I psychiatric disorder other than specific phobias (assessed through M.I.N.I. interview). Subjects presenting with symptoms of anxiety or depression, but not meeting criteria for Depressive Disorders, Bipolar Disorder, Panic Disorder, GAD, OCD or SAD, will be allowed in the study.
• Regular treatment with hormonal medications, SSRIs, tricyclic antidepressant, mood stabilizer, oral neuroleptics, sedatives or hypnotics, over-the-counter agents known to influence hot flushes or mood within 4 weeks prior to screening visit; used of depot 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

MGH Center for Perinatal and Women's Mental Health

Boston, Massachusetts, 02116, United States

Location

Related Links

• MGH Center for Perinatal and Women's Mental Health

MeSH Terms

Conditions

Hot Flashes; Parasomnias

Interventions

Paroxetine

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Lee S. Cohen, M.D.

  MGH Center for Perinatal and Women's Mental Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 22, 2005
• First Posted: September 26, 2005
• Study Start: September 1, 2004
• Study Completion: September 1, 2006
• Last Updated: November 24, 2010

Record last verified: 2010-11

Locations

US (1)