Trial Outcomes & Findings for Duloxetine for Menopausal Depression (NCT NCT01117857)

Last Updated: 2014-08-21

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

29 participants

Primary outcome timeframe

Baseline to week 9

Results posted on

2014-08-21

Participant Flow

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

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	22
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Lost to Follow-up	4
Overall Study Withdrawal by Subject	4
Overall Study Physician Decision	1

Baseline Characteristics

Duloxetine for Menopausal Depression

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Duloxetine n=19 Participants 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.
Age, Continuous	52.1 years STANDARD_DEVIATION 5.4 • n=93 Participants
Sex: Female, Male Female	19 Participants n=93 Participants
Sex: Female, Male Male	0 Participants n=93 Participants
Region of Enrollment United States	19 participants n=93 Participants
Marital Status Married	3 participants n=93 Participants
Marital Status Separated/divorced/widowed	5 participants n=93 Participants
Marital Status Never married/single	8 participants n=93 Participants
Marital Status Decline to answer	3 participants n=93 Participants
Education Less than high school degree	1 participants n=93 Participants
Education High school diploma or GED	5 participants n=93 Participants
Education Some college	9 participants n=93 Participants
Education Bachelor's degree	4 participants n=93 Participants
Employment Status Full- or part-time work	4 participants n=93 Participants
Employment Status Homemaker	4 participants n=93 Participants
Employment Status Unemployed/disabled	7 participants n=93 Participants
Employment Status Student	1 participants n=93 Participants
Employment Status Volunteer	1 participants n=93 Participants
Employment Status Retired	2 participants n=93 Participants
Menopause Status Perimenopausal	11 participants n=93 Participants
Menopause Status Naturally Postmenopausal	7 participants n=93 Participants
Menopause Status Surgically Postmenopausal	1 participants n=93 Participants
Past hormone therapy use Yes	1 participants n=93 Participants
Past hormone therapy use No	18 participants n=93 Participants

PRIMARY outcome

Timeframe: Baseline to week 9

Population: Of the 19 participants who received study medication, 16 were considered evaluable for the purpose of analyses as they returned for at least one assessment after starting the study intervention.

Outcome measures

Outcome measures
Measure	Duloxetine n=16 Participants 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.
Change in Depression Scores as Measured by the Hamilton Rating Scale for Depression	-7.5 units on a scale Interval -11.0 to -4.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Duloxetine n=16 Participants 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.
Change in Menopause Symptoms as Measured by the Greene Climacteric Scale	-7.5 units on a scale Interval -12.5 to -2.5

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Duloxetine n=16 Participants 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.
Change in Anxiety as Measured by the Generalized Anxiety Disorder Questionnaire (GAD-7)	-2.5 units on a scale Interval -7.5 to -0.5

OTHER_PRE_SPECIFIED outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Duloxetine n=16 Participants 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.
Change in Hot Flash Interference With Daily Activities and Quality of Life as Measured by the Hot Flash Related Daily Interference Scale (HFRDIS)	-13.5 units on a scale Interval -44.0 to -7.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Duloxetine n=16 Participants 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.
Change in Overall Well Being Measured by the Clinical Global Impression Scale (CGI)	-2 units on a scale Interval -3.0 to -1.0

Adverse Events

Duloxetine

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Duloxetine n=22 participants at risk 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.
Gastrointestinal disorders Dry Mouth	22.7% 5/22
Gastrointestinal disorders Gastrointestinal Discomfort	31.8% 7/22
Musculoskeletal and connective tissue disorders Muscle tension and aches	9.1% 2/22

Additional Information

Dr. Marlene Freeman, MD

Massachusetts General Hospital

Phone: 617-643-6403

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place