Duloxetine for Perimenopausal Depression

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00517985

First Posted: August 17, 2007

Last Update Posted: July 9, 2012

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborator:

Eli Lilly and Company

Information provided by (Responsible Party):

University of Arizona

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 4


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment
Official Title:	Duloxetine for Perimenopausal Depression

Resource links provided by NLM:

Drug Information available for: Duloxetine Duloxetine hydrochloride

U.S. FDA Resources

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 ]


Enrollment:	7
Study Start Date:	February 2007
Study Completion Date:	June 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Intervention Details:

During the current study, for a short period of time participants will receive a placebo (a pill that looks like the study drug but which does not contain any medication), although during the majority of the study, participants will be receiving the actual study medication (Duloxetine). The initial dose of Duloxetine to be given will be a 30 mg dose with the dosage increased over time to 60 mg per day. This study will be blinded, meaning that participants will not know whether they are taking placebo or the study drug. However, all subjects will receive duloxetine for the majority of the time they are enrolled in the trial. Investigators will know when subjects are receiving the placebo but in order to maintain the blinding of this study, the study staff will not be able to tell participants when they are taking placebo and when they are taking Duloxetine.

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Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	40 Years and older (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00517985

Locations


United States, Arizona
Women's Mental Health Program; University of Arizona; Department of Psychiatry
Tucson, Arizona, United States, 85724

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


Responsible Party:	University of Arizona
ClinicalTrials.gov Identifier:	NCT00517985 History of Changes
Other Study ID Numbers:	F1JUSX026
First Submitted:	March 9, 2007
First Posted:	August 17, 2007
Last Update Posted:	July 9, 2012
Last Verified:	July 2012

Keywords provided by University of Arizona:


perimenopausal depression duloxetine cymbalta major depressive disorder women

Additional relevant MeSH terms:


Depression Depressive Disorder Depressive Disorder, Major Behavioral Symptoms Mood Disorders Mental Disorders Duloxetine Hydrochloride Serotonin and Noradrenaline Reuptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators	Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Antidepressive Agents Psychotropic Drugs Dopamine Agents

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