Effect of the Menstrual Cycle on the Symptoms of Depression and Treatment Response

NCT00188396 | Completed

• 1 other identifier: 04-0225-AE
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives: This prospective investigation will compare premenopausal, perimenopausal and postmenopausal women's response to antidepressant medication. The effects of the menstrual cycle on the symptoms of depression and antidepressant response will also be examined. Hypotheses: Premenopausal women will show a significantly better response to a selective serotonin reuptake inhibitor (SSRI) than peri- or postmenopausal women. Premenopausal women during lower estrogen phases of the menstrual cycle will complain of increased depressive symptoms despite treatment. Perimenopausal and postmenopausal women with irregular periods and generally low estrogen levels will show less symptom variability over time. Method Subjects: Eighty-four women (28 premenopausal, 28 perimenopausal, 28 postmenopausal) meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for major depressive disorder will be enrolled in the study. Procedure: All the subjects will be followed prospectively for 12 weeks and through 2 menstrual cycles while receiving treatment with a standard SSRI antidepressant agent. All eligible women will have a structured clinical interview and will complete questionnaires assessing their depressive symptoms. Blood samples will be collected to evaluate for reproductive hormone levels during the late follicular, midluteal and late luteal phases of the menstrual cycle for two consecutive cycles. Serum SSRI levels will also be collected at these times. As the women in the perimenopausal and postmenopausal groups either have irregular menstrual cycles or no longer cycle, they will have blood samples drawn at baseline and on 6 other occasions. Research Implications: As the majority of psychiatric medication is prescribed to women, understanding the interplay between the menstrual cycle and antidepressant medication will ultimately translate into more diverse and improved patient care. The proposed study is one within a developing research program, which will in part be further guided by this study.

Conditions

Major Depressive Disorder; Depression

Keywords

Major Depressive Disorder; Women's Mental Health; Hormones; Citalopram; Antidepressive agents; Mental Health

Outcome Measures

Primary Outcomes (1)

• Hamilton Depression Rating Scale (HAM-D)

  12 weeks

Secondary Outcomes (5)

• Clinical Global Impression (CGI)

  12 weeks

• Trimodal Anxiety Questionnaire (TAQ)

  12 weeks

• Women's Health Questionnaire

  12 weeks

• Prism calender

  12 weeks

• Biological measures (β-estradiol, estrogen, progesterone, follicle-stimulating hormone [FSH], luteinizing hormone [LH], and testosterone)

  12 weeks

Interventions

Citalopram DRUG

Eligibility Criteria

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

You may qualify if:

• Women, ages 18-65 years old
• Fulfilling DSM-IV criteria for major depressive disorder, which is not secondary to another pre-existing psychiatric condition or to a medical condition
• Hamilton Depression Rating Scale (HAM-D-17) total score of at least 16
• Able and willing to give meaningful written consent
• women premenopausal (having monthly periods); 28 women perimenopausal (having irregular periods); and 28 women menopausal (without a period for at least one year).
• In good physical health.

You may not qualify if:

• Subjects who are taking the birth control pill currently or within the last 3 months
• Subjects who plan to become pregnant or were pregnant within the last year
• Subjects who are taking hormone replacement therapy (or received it within the last three \[3\] months)
• Subjects who meet DSM-IV criteria for substance abuse (consume \> 4 alcoholic beverages per day)
• Subjects who have tried 2 antidepressants for this episode
• Subjects who have additional diagnosed psychiatric conditions (i.e. anxiety, substance use and psychotic disorders)
• Subjects who have had both ovaries surgically removed.

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Ontario Mental Health Foundation: collaborator

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

Related Publications (1)

• Grigoriadis S, Kennedy SH, Bagby RM. A comparison of antidepressant response in younger and older women. J Clin Psychopharmacol. 2003 Aug;23(4):405-7. doi: 10.1097/01.jcp.0000085415.08426.c6.

  PMID: 12920418 BACKGROUND

MeSH Terms

Conditions

Depressive Disorder, Major; Depression; Psychological Well-Being

Interventions

Citalopram

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Personal Satisfaction

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Sophie Grigoriadis, PhD, MD, FRCPC

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 16, 2005
• Study Start: April 1, 2004
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: March 13, 2009

Record last verified: 2007-01

Locations

CA (1)