Duloxetine for Perimenopausal Depression
This study has been completed.
Sponsor:
University of Arizona
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
University of Arizona
ClinicalTrials.gov Identifier:
NCT00517985
First received: March 9, 2007
Last updated: July 5, 2012
Last verified: July 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Duloxetine for Perimenopausal Depression |
Resource links provided by NLM:
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 ] [ Designated as safety issue: No ]
- Reduction of the HAM-D score to less than or equal to 7 at week 9 [ Time Frame: 9 Weeks ] [ Designated as safety issue: No ]
- Change of CGI score achievement to "very much improved" or "much improved" at week 9 [ Time Frame: 9 Weeks ] [ Designated as safety issue: No ]
- A 50% decrease in the GCS at week 9. [ Time Frame: 9 Weeks ] [ Designated as safety issue: No ]
| 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:
-
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.
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
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
No publications provided
| Responsible Party: | University of Arizona |
| ClinicalTrials.gov Identifier: | NCT00517985 History of Changes |
| Other Study ID Numbers: | F1JUSX026 |
| Study First Received: | March 9, 2007 |
| Last Updated: | July 5, 2012 |
| Health Authority: | United States: Institutional Review Board |
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 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 May 23, 2013