Duloxetine for Menopausal Depression

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01117857

Enrollment

Registered

2010-05-06

Start date

2009-08-31

Completion date

2011-06-30

Last updated

2014-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, Menopause, Vasomotor Symptoms

Brief summary

The primary objective of the study is to determine if an eight-week intervention with duloxetine significantly reduces depressive symptoms in symptomatic menopausal women. It is hypothesized that an eight-week trial with duloxetine promotes significant improvement in depression symptoms in menopausal women. The secondary aim of the study is to examine if an eight-week intervention with duloxetine significantly reduces vasomotor symptoms in symptomatic menopausal women. It is hypothesized that an eight-week trial with duloxetine promotes significant improvement in vasomotor symptoms in menopausal women.

Interventions

DRUGDuloxetine

One-week placebo lead-in, followed by Duloxetine 30 mg per day for one week. After one week on 30 mg, the dosage will be increased 60 mg per day for the remaining 7 weeks of the study.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

40 Years to No maximum

Healthy volunteers

Inclusion criteria

* Women age 40 years old or older * Menopausal symptoms of at least 3 months duration, including irregular periods and/or hot flushes * Minimum score of 15 on the Hamilton Rating Scale for Depression (17-item), * Patients will meet criteria for a major depressive episode, verified using the Mini International Neuropsychiatric Interview (MINI). * Subjects will be able to be treated on an outpatient basis, and * Subjects will be able to provide written informed consent

Exclusion criteria

* Subjects presently taking antidepressant medication, * Subjects currently using hormone replacement therapy, * Other Axis I disorders, except Generalized Anxiety Disorder or Panic Disorder, according to the Mini International Neuropsychiatric Interview (MINI) * uncontrolled narrow angle glaucoma * known hypersensitivity to duloxetine or any of the inactive ingredients * treatment with a monoamine oxidase inhibitor (MAOI) within 14 days of randomization or potential need to use an MAOI during the study or within 5 days of discontinuation of study drug. * Presence of psychotic symptoms, * History of mania or hypomania, * HAM-D suicide item score \> 3, * End stage renal disease or severe renal impairment * Abnormal uterine bleeding (heavy or prolonged uterine bleeding, menstrual periods occurring more frequently than every 3 weeks, bleeding after sexual intercourse, spotting between periods) that has not been evaluated by a gynecologist. * Subjects with serious or unstable medical illness, including alcohol or substance abuse, cardiovascular, hepatic, respiratory, endocrine, neuralgic, or hematologic disease, history of seizure disorder * Subjects taking medications that may interact with duloxetine

Design outcomes

Primary

Measure	Time frame	Description
Change in Depression Scores as Measured by the Hamilton Rating Scale for Depression	Baseline to week 9	The HAM-D is a 17-item well-validated and reliable measure of current depressive symptoms and their severity. Eight items are scored on a five-point scale (0-4), and nine are scored on a three-point scale (0-2) for a total score range of 0-50. A higher score indicates greater symptom severity.

Secondary

Measure	Time frame	Description
Change in Menopause Symptoms as Measured by the Greene Climacteric Scale	Baseline to week 9	The Greene Climacteric Scale (GCS) is a 21-item scale used to quantify the severity of perimenopausal somatic symptoms. Each item is scored 0-3 for a total range of 0-63, with a higher score indicating greater symptom severity.

Other

Measure	Time frame	Description
Change in Anxiety as Measured by the Generalized Anxiety Disorder Questionnaire (GAD-7)	Baseline to week 9	The GAD-7 is a valid and efficient tool for screening anxiety and assessing its severity in clinical practice and research. Subjects rate the items for severity on a 4-point scale from 0 (not at all) to 3 (nearly every day) for a total range of 0-21. A higher score indicates greater anxiety symptom burden.
Change in Hot Flash Interference With Daily Activities and Quality of Life as Measured by the Hot Flash Related Daily Interference Scale (HFRDIS)	Baseline to week 9	The HFRDIS is a 10-item self-report questionnaire in which subjects rate the degree to which hot flashes interfere with daily activities and quality-of-life during the prior week. Each item is rated on a scale from 0 (does not interfere) to 10 (completely interferes) for a total score range of 0-100 (higher score indicates greater symptom burden/interference).
Change in Overall Well Being Measured by the Clinical Global Impression Scale (CGI)	Baseline to week 9	The CGI is a scale to measure the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Severity is ranked 1, normal, not at all ill; 2, borderline ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. A higher score indicates greater symptom severity.

Countries

United States

Participant flow

Pre-assignment details

Of the 29 subjects consented, 7 were found to be ineligible at the screening visit.

Participants by arm

Arm	Count
Duloxetine After a one-week placebo lead-in, all eligible subjects will receive Duloxetine 30 mg per day for one week. After one week on 30 mg, the dosage will be increased 60 mg Duloxetine per day for 7 weeks. Duloxetine: One-week placebo lead-in, followed by Duloxetine 30 mg per day for one week. After one week on 30 mg, the dosage will be increased 60 mg per day for the remaining 7 weeks of the study.	19
Total	19

Arm

Count

Duloxetine

After a one-week placebo lead-in, all eligible subjects will receive Duloxetine 30 mg per day for one week. After one week on 30 mg, the dosage will be increased 60 mg Duloxetine per day for 7 weeks. Duloxetine: One-week placebo lead-in, followed by Duloxetine 30 mg per day for one week. After one week on 30 mg, the dosage will be increased 60 mg per day for the remaining 7 weeks of the study.

Total

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Lost to Follow-up	4
Overall Study	Physician Decision	1
Overall Study	Withdrawal by Subject	4

Baseline characteristics

Characteristic	Duloxetine
Age, Continuous	52.1 years STANDARD_DEVIATION 5.4
Education Bachelor's degree	4 participants
Education High school diploma or GED	5 participants
Education Less than high school degree	1 participants
Education Some college	9 participants
Employment Status Full- or part-time work	4 participants
Employment Status Homemaker	4 participants
Employment Status Retired	2 participants
Employment Status Student	1 participants
Employment Status Unemployed/disabled	7 participants
Employment Status Volunteer	1 participants
Marital Status Decline to answer	3 participants
Marital Status Married	3 participants
Marital Status Never married/single	8 participants
Marital Status Separated/divorced/widowed	5 participants
Menopause Status Naturally Postmenopausal	7 participants
Menopause Status Perimenopausal	11 participants
Menopause Status Surgically Postmenopausal	1 participants
Past hormone therapy use No	18 participants
Past hormone therapy use Yes	1 participants
Region of Enrollment United States	19 participants
Sex: Female, Male Female	19 Participants
Sex: Female, Male Male	0 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	9 / 22
serious Total, serious adverse events	0 / 22

Outcome results

Primary

Change in Depression Scores as Measured by the Hamilton Rating Scale for Depression

The HAM-D is a 17-item well-validated and reliable measure of current depressive symptoms and their severity. Eight items are scored on a five-point scale (0-4), and nine are scored on a three-point scale (0-2) for a total score range of 0-50. A higher score indicates greater symptom severity.