Effect of the Menstrual Cycle on the Symptoms of Depression and Treatment Response - Full Text View

Sponsor:	University Health Network, Toronto
Collaborator:	Ontario Mental Health Foundation
Information provided by:	University Health Network, Toronto
ClinicalTrials.gov Identifier:	NCT00188396

Purpose

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.

Condition	Intervention
Major Depressive Disorder Depression	Drug: Citalopram

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	The Effect of the Menstrual Cycle on the Symptoms of Depression and Treatment Response: A Comparison of Premenopausal, Perimenopausal and Postmenopausal Women

Resource links provided by NLM:

MedlinePlus related topics: Antidepressants Depression Menstruation Mental Health

Drug Information available for: Benzetimide Dexetimide Citalopram hydrobromide Citalopram Escitalopram Escitalopram oxalate

U.S. FDA Resources

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:

Hamilton Depression Rating Scale (HAM-D) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Clinical Global Impression (CGI) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Trimodal Anxiety Questionnaire (TAQ) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Women's Health Questionnaire [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Prism calender [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Biological measures (β-estradiol, estrogen, progesterone, follicle-stimulating hormone [FSH], luteinizing hormone [LH], and testosterone) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment:	44
Study Start Date:	April 2004
Study Completion Date:	October 2008
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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
28 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.

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00188396

Locations

Canada, Ontario
University Health Network
Toronto, Ontario, Canada, M5G 2C4

Sponsors and Collaborators

University Health Network, Toronto

Ontario Mental Health Foundation

Investigators

Principal Investigator:

Sophie Grigoriadis, PhD, MD, FRCPC

University Health Network, Toronto

More Information

Publications:

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.

Responsible Party:	Sophie Grigoriadis, PhD, MD, FRCPC, University Health Network
ClinicalTrials.gov Identifier:	NCT00188396 History of Changes
Other Study ID Numbers:	04-0225-AE
Study First Received:	September 9, 2005
Last Updated:	March 12, 2009
Health Authority:	Canada: Ethics Review Committee

Keywords provided by University Health Network, Toronto:

Major Depressive Disorder
Women's Mental Health
Hormones

Citalopram
Antidepressive agents
Mental Health

Additional relevant MeSH terms:

Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Antidepressive Agents
Citalopram
Dexetimide
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Antidepressive Agents, Second-Generation

Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents

ClinicalTrials.gov processed this record on February 09, 2012