Back to resultsEstrogen and Perimenopausal Depression
Primary Purpose
Depressive Disorder, Major, Menopause
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Estrogen
Sponsored by
About this trial
This is an interventional treatment trial for Depressive Disorder, Major focused on measuring depression, menopause, perimenopause, mood, memory, perimenopausal, antidepressant, estrogen
Eligibility Criteria
Inclusion Criteria: Clinical Diagnosis of Unipolar Major Depression, currently taking antidepressants HAM-D between 10 and 17 Exclusion Criteria: History of Psychosis, breast cancer, smoking, dementia, clotting disorders Current substance abuse
Sites / Locations
- UCLA Neuropsychiatric Institute & Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Treatment
Placebo
Arm Description
0.625 mg/day of conjugated estrogen
Daily placebo for conjugated estrogen
Outcomes
Primary Outcome Measures
Mood
17-item Hamilton Depression (HAM-D17) scores range from 0 to 50, and lower scores are better outcomes.
Secondary Outcome Measures
Memory
The Buschke Selective Reminding Task (SRT) is a standardized measure of verbal learning that presents 12 words to the subject who is asked to immediately recall as many words as possible. The examiner then presents words that the subject was unable to recall until the subject can recall all 12 words without prompting twice, or until the examiner has presented prompts up to 12 times. Consistent Long-Term Retrieval score is the number of words that the subject recalls without receiving prompts and indicates how well the subject consolidates the new information during the learning phase (encoding). Scores indicate the sum of consistent long-term word retrieval across the 12 trials and range from 0 to 144, with higher scores indicating better learning.
Full Information
NCT ID
NCT00229450
First Posted
September 28, 2005
Last Updated
February 21, 2020
Sponsor
University of California, Los Angeles
Collaborators
National Alliance for Research on Schizophrenia and Depression
1. Study Identification
Unique Protocol Identification Number
NCT00229450
Brief Title
Estrogen and Perimenopausal Depression
Official Title
Dose Response Effects of Estrogen Augmentation in Mood & Memory in Perimenopausal Depression
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
April 2002 (undefined)
Primary Completion Date
August 2003 (Actual)
Study Completion Date
August 2004 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Los Angeles
Collaborators
National Alliance for Research on Schizophrenia and Depression
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Major, Menopause
Keywords
depression, menopause, perimenopause, mood, memory, perimenopausal, antidepressant, estrogen
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
0.625 mg/day of conjugated estrogen
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Daily placebo for conjugated estrogen
Intervention Type
Drug
Intervention Name(s)
Estrogen
Intervention Description
0.625 mg/day of conjugated Estrogen
Primary Outcome Measure Information:
Title
Mood
Description
17-item Hamilton Depression (HAM-D17) scores range from 0 to 50, and lower scores are better outcomes.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Memory
Description
The Buschke Selective Reminding Task (SRT) is a standardized measure of verbal learning that presents 12 words to the subject who is asked to immediately recall as many words as possible. The examiner then presents words that the subject was unable to recall until the subject can recall all 12 words without prompting twice, or until the examiner has presented prompts up to 12 times. Consistent Long-Term Retrieval score is the number of words that the subject recalls without receiving prompts and indicates how well the subject consolidates the new information during the learning phase (encoding). Scores indicate the sum of consistent long-term word retrieval across the 12 trials and range from 0 to 144, with higher scores indicating better learning.
Time Frame
6 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical Diagnosis of Unipolar Major Depression, currently taking antidepressants
HAM-D between 10 and 17
Exclusion Criteria:
History of Psychosis, breast cancer, smoking, dementia, clotting disorders
Current substance abuse
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melinda L. Morgan, Ph.D.
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA Neuropsychiatric Institute & Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
15960574
Citation
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.
Results Reference
background
PubMed Identifier
12112157
Citation
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.
Results Reference
background
Learn more about this trial
Estrogen and Perimenopausal Depression
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