Duloxetine for Perimenopausal Depression

This study is currently recruiting participants.

Verified by University of Arizona, August 2007

First Received: March 9, 2007 Last Updated: August 17, 2007 History of Changes

Sponsors and Collaborators:	University of Arizona Eli Lilly and Company
Information provided by:	University of Arizona
ClinicalTrials.gov Identifier:	NCT00517985

Purpose

Recently, antidepressants have been explored as a class of medications to treat major depression in the context of perimenopause, as well as the somatic symptoms of perimenopause (such as hot flashes). Duloxetine (Cymbalta) is one of the newer antidepressants approved for the treatment of Major Depressive Disorder (MDD). Therefore, the current study is designed to assess the efficacy of duloxetine in a sample of women who are perimenopausal and meet criteria for MDD. We will assess impact on MDD and perimenopausal symptoms.

Condition	Intervention	Phase
Major Depressive Disorder	Drug: Duloxetine	Phase IV

MedlinePlus related topics: Antidepressants Depression

Drug Information available for: Duloxetine Duloxetine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Duloxetine for Perimenopausal Depression

Further study details as provided by University of Arizona:

Primary Outcome Measures:

Reduction of the initial HAM-D by 50% or more at week 9 of the trial [ Time Frame: 9 Weeks ]
Reduction of the HAM-D score to less than or equal to 7 at week 9 [ Time Frame: 9 Weeks ]
Change of CGI score achievement to "very much improved" or "much improved" at week 9 [ Time Frame: 9 Weeks ]
A 50% decrease in the GCS at week 9. [ Time Frame: 9 Weeks ]

Estimated Enrollment:	20
Study Start Date:	February 2007

Show Detailed Description

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.
Perimenopausal symptoms of at least 3 months duration, including irregular periods and/or hot flashes.
Minimum score of 15 on the Hamilton Rating Scale for Depression (17-item).
Subjects must be able to be treated on an outpatient basis.
Subjects must be able to provide written informed consent.

Exclusion Criteria:

Subjects presently taking antidepressant medication.
Subjects currently using hormone replacement therapy.
Subjects who are pregnant.
Subjects who have hepatic disease.
Other Axis I disorders, except Generalized Anxiety Disorder or Panic Disorder.
"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 study drug administration 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.
Hamilton Rating Scale for Depression (HAM-D) suicide item score > 2.
End stage renal disease or severe renal impairment.
Abnormal uterine bleeding that has not been evaluated by a gynecologist (heavy or prolonged uterine bleeding, menstrual periods occurring more frequently than every 3 weeks, bleeding after sexual intercourse, spotting between periods).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00517985

Contacts

Contact: Kathy W Smith, M.D.

520-626-6673

kwsmith@email.arizona.edu

Locations

United States, Arizona
Women's Mental Health Program; University of Arizona; Department of Psychiatry	Recruiting
Tucson, Arizona, United States, 85724
Contact: Kathy W Smith, M.D. 520-626-6673 kwsmith@email.arizona.edu

Sponsors and Collaborators

University of Arizona

Eli Lilly and Company

Investigators

Principal Investigator:

Kathy W Smith, M.D.

University of Arizona: Department of Psychiatry

More Information

No publications provided

Study ID Numbers:	F1JUSX026
Study First Received:	March 9, 2007
Last Updated:	August 17, 2007
ClinicalTrials.gov Identifier:	NCT00517985 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Arizona:

perimenopausal depression
duloxetine
cymbalta
major depressive disorder
women

Study placed in the following topic categories:

Dopamine Uptake Inhibitors
Neurotransmitter Agents
Depression
Adrenergic Agents
Psychotropic Drugs
Depressive Disorder, Major
Depressive Disorder
Serotonin Uptake Inhibitors

Duloxetine
Serotonin
Behavioral Symptoms
Dopamine
Mental Disorders
Mood Disorders
Dopamine Agents
Antidepressive Agents

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Depression
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Psychotropic Drugs
Depressive Disorder, Major
Depressive Disorder

Serotonin Uptake Inhibitors
Duloxetine
Pharmacologic Actions
Behavioral Symptoms
Serotonin Agents
Mental Disorders
Therapeutic Uses
Mood Disorders
Dopamine Agents
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on May 07, 2009