Duloxetine for Menopausal Depression

Depression Clinical Trial

Official title:

Duloxetine for Menopausal Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01117857
• Other study ID #: 2009P000956
• Status: Completed
• Phase: Phase 4
• First received: May 3, 2010
• Last updated: August 5, 2014
• Start date: August 2009
• Est. completion date: June 2011

Study information

• Verified date: August 2014
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Menopause
• Vasomotor Symptoms

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

References & 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/ — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Anxiety as Measured by the Generalized Anxiety Disorder Questionnaire (GAD-7)	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.	Baseline to week 9	No
Other	Change in Hot Flash Interference With Daily Activities and Quality of Life as Measured by the Hot Flash Related Daily Interference Scale (HFRDIS)	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).	Baseline to week 9	No
Other	Change in Overall Well Being Measured by the Clinical Global Impression Scale (CGI)	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.	Baseline to week 9	No
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.	Baseline to week 9	No
Secondary	Change in Menopause Symptoms as Measured by the Greene Climacteric Scale	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.	Baseline to week 9	No