Duloxetine for Perimenopausal Depression

NCT00517985 | Completed Phase 4

• 1 other identifier: F1JUSX026
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

perimenopausal depression; duloxetine; cymbalta; major depressive disorder; women

Outcome Measures

Primary Outcomes (4)

• Reduction of the initial HAM-D by 50% or more at week 9 of the trial

  9 Weeks

• Reduction of the HAM-D score to less than or equal to 7 at week 9

  9 Weeks

• Change of CGI score achievement to "very much improved" or "much improved" at week 9

  9 Weeks

• A 50% decrease in the GCS at week 9.

  9 Weeks

Interventions

Duloxetine DRUG

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.

Eligibility Criteria

• Age: 40 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Arizona: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

Women's Mental Health Program; University of Arizona; Department of Psychiatry

Tucson, Arizona, 85724, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Kathy W Smith, M.D.

  University of Arizona: Department of Psychiatry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2007
• First Posted: August 17, 2007
• Study Start: February 1, 2007
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: July 9, 2012

Record last verified: 2012-07

Locations

US (1)