Duloxetine for Menopausal Depression

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Marlene P. Freeman, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01117857
First received: May 3, 2010
Last updated: June 18, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Depression
Menopause
Vasomotor Symptoms
Drug: Duloxetine
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Duloxetine for Menopausal Depression

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Change in depression scores as measured by the Hamilton Rating Scale for Depression [ Time Frame: Measured at baseline, week 1, week 2, week 3, week 5, week 7, and week 9 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in menopause symptoms as measured by the Greene Climacteric Scale [ Time Frame: Measure assessed at baseline, week 1, week 2, week 3, week 5, week 7, and week 9 ] [ Designated as safety issue: No ]

Enrollment: 29
Study Start Date: August 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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.
Other Name: Cymbalta

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01117857

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Marlene P Freeman, MD Massachusetts General Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Marlene P. Freeman, MD, Director of Clinical Services at the Center for Women's Mental Health, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01117857     History of Changes
Other Study ID Numbers: 2009P000956
Study First Received: May 3, 2010
Last Updated: June 18, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Duloxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Adrenergic Agents
Dopamine Uptake Inhibitors
Dopamine Agents
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014