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Duloxetine for Perimenopausal Depression

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ClinicalTrials.gov Identifier: NCT00517985
Recruitment Status : Completed
First Posted : August 17, 2007
Last Update Posted : July 9, 2012
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
University of Arizona

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Major Depressive Disorder Drug: Duloxetine Phase 4

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Duloxetine for Perimenopausal Depression
Study Start Date : February 2007
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

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Arms and Interventions
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Intervention Details:
    Drug: Duloxetine
    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.

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

Eligibility Criteria
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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
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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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: University of Arizona
ClinicalTrials.gov Identifier: NCT00517985     History of Changes
Other Study ID Numbers: F1JUSX026
First Posted: August 17, 2007    Key Record Dates
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