Estrogen and Perimenopausal Depression

Menopause Clinical Trial

Official title:

Dose Response Effects of Estrogen Augmentation in Mood & Memory in Perimenopausal Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00229450
• Other study ID #: NARSAD06806-001
• Secondary ID: 06806-00104-05-0
• Status: Completed
• Phase: Phase 4
• Start date: April 2002
• Est. completion date: August 2004

Study information

• Verified date: February 2020
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: August 2004
• Est. primary completion date: August 2003
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Menopause

Intervention

Drug:
• Estrogen
0.625 mg/day of conjugated Estrogen

Locations

Country	Name	City	State
United States	UCLA Neuropsychiatric Institute & Hospital	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	National Alliance for Research on Schizophrenia and Depression

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mood	17-item Hamilton Depression (HAM-D17) scores range from 0 to 50, and lower scores are better outcomes.	6 weeks
Secondary	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.	6 weeks