NCT00229450

Brief Summary

During perimenopause (the time just prior to menopause), women often notice many biological, psychological, and social changes. In particular, some women experience depressive symptoms during perimenopause that are severe enough to warrant antidepressant medication. Whether or not women with perimenopausal depression respond to antidepressant medication may depend on the level of estrogen in their blood. This study will investigate whether estrogen will help women who only partially respond to antidepressant medications, as well as examine how different doses of estrogen may affect individuals differently.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Apr 2002

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2002

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2003

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2004

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 28, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 29, 2005

Completed
Last Updated

February 25, 2020

Status Verified

February 1, 2020

Enrollment Period

1.3 years

First QC Date

September 28, 2005

Last Update Submit

February 21, 2020

Conditions

Depressive Disorder, MajorMenopause

Keywords

depressionmenopauseperimenopausemoodmemoryperimenopausalantidepressantestrogen

Outcome Measures

Primary Outcomes (1)

  • Mood

    17-item Hamilton Depression (HAM-D17) scores range from 0 to 50, and lower scores are better outcomes.

    6 weeks

Secondary Outcomes (1)

  • Memory

    6 weeks

Study Arms (2)

Treatment

EXPERIMENTAL

0.625 mg/day of conjugated estrogen

Drug: Estrogen

Placebo

PLACEBO COMPARATOR

Daily placebo for conjugated estrogen

Drug: Estrogen

Interventions

EstrogenDRUG

0.625 mg/day of conjugated Estrogen

PlaceboTreatment

Eligibility Criteria

Age40 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Clinical Diagnosis of Unipolar Major Depression, currently taking antidepressants
  • HAM-D between 10 and 17

You may not qualify if:

  • History of Psychosis, breast cancer, smoking, dementia, clotting disorders
  • Current substance abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA Neuropsychiatric Institute & Hospital

Los Angeles, California, 90024, United States

Location

Related Publications (2)

  • Morgan ML, Cook IA, Rapkin AJ, Leuchter AF. Estrogen augmentation of antidepressants in perimenopausal depression: a pilot study. J Clin Psychiatry. 2005 Jun;66(6):774-80. doi: 10.4088/jcp.v66n0617.

    PMID: 15960574BACKGROUND

  • Cook IA, Morgan ML, Dunkin JJ, David S, Witte E, Lufkin R, Abrams M, Rosenberg S, Leuchter AF. Estrogen replacement therapy is associated with less progression of subclinical structural brain disease in normal elderly women: a pilot study. Int J Geriatr Psychiatry. 2002 Jul;17(7):610-8. doi: 10.1002/gps.644.

    PMID: 12112157BACKGROUND

MeSH Terms

Conditions

Depressive Disorder, MajorDepression

Interventions

Estrogens

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

HormonesHormones, Hormone Substitutes, and Hormone AntagonistsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Melinda L. Morgan, Ph.D.

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2005

First Posted

September 29, 2005

Study Start

April 1, 2002

Primary Completion

August 1, 2003

Study Completion

August 1, 2004

Last Updated

February 25, 2020

Record last verified: 2020-02

Locations

US(1)