Duloxetine for Menopausal Depression

NCT01117857 | Completed Phase 4 Results

• 1 other identifier: 2009P000956
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Menopause; Vasomotor Symptoms

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to week 9

Secondary Outcomes (1)

• Change in Menopause Symptoms as Measured by the Greene Climacteric Scale

  Baseline to week 9

Other Outcomes (3)

• Change in Anxiety as Measured by the Generalized Anxiety Disorder Questionnaire (GAD-7)

  Baseline to week 9

• 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

• Change in Overall Well Being Measured by the Clinical Global Impression Scale (CGI)

  Baseline to week 9

Study Arms (1)

Duloxetine

EXPERIMENTAL

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.

Drug: Duloxetine

Interventions

Duloxetine DRUG

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.

Also known as: Cymbalta

Duloxetine

Eligibility Criteria

• Age: 40 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• Freeman MP, Hirschberg AM, Wang B, Petrillo LF, Connors S, Regan S, Joffe H, Cohen LS. Duloxetine for major depressive disorder and daytime and nighttime hot flashes associated with the menopausal transition. Maturitas. 2013 Jun;75(2):170-4. doi: 10.1016/j.maturitas.2013.03.007. Epub 2013 Apr 17.

  PMID: 23602542 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Depression

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Marlene Freeman, MD
• Organization: Massachusetts General Hospital

mfreeman@partners.org

617-643-6403

Study Officials

• Marlene P Freeman, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Clinical Services at the Center for Women's Mental Health

Study Record Dates

• First Submitted: May 3, 2010
• First Posted: May 6, 2010
• Study Start: August 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: August 21, 2014
• Results First Posted: August 21, 2014

Record last verified: 2014-08

Locations

US (1)