Duloxetine for Perimenopausal Depression
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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. |
ClinicalTrials.gov Identifier: NCT00517985 |
Recruitment Status
:
Completed
First Posted
: August 17, 2007
Last Update Posted
: July 9, 2012
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Major Depressive Disorder | Drug: Duloxetine | Phase 4 |

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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Drug: Duloxetine
- 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 ]

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Ages Eligible for Study: | 40 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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).

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
United States, Arizona | |
Women's Mental Health Program; University of Arizona; Department of Psychiatry | |
Tucson, Arizona, United States, 85724 |
Principal Investigator: | Kathy W Smith, M.D. | University of Arizona: Department of Psychiatry |
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 |