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View Clinical Trial (Medical Research Study)
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Evaluating the Effects of Stress in Pregnancy - NCT00525226-30322 (Clinical Trial 182472)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy182472.aspx
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** Please review additional "Nearby Studies" on right ----->
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| City: |
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Atlanta |
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State:
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GA |
| Zip Code: |
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30322 |
| Conditions: |
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Depression - Panic Disorder - Generalized Anxiety Disorder - Post-Traumatic Stress Disorder - Obsessive Compulsive Disorder (OCD) |
| Purpose: |
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This study will evaluate pregnant women with a past or current diagnosis of depression or
anxiety to gain a better understanding of how these disorders can affect an infant's
development, both during and after pregnancy.
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| Study summary: |
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Depression and anxiety are serious conditions affecting millions of people each year. In
fact, it is estimated that approximately one in every four women will be treated for a mood
disorder, such as depression or anxiety, at some point in her life. As effective treatment
options continue to develop, many women diagnosed with depression or anxiety are able to
resume normal lives and may choose to become pregnant. However, studies suggest that the
intrauterine environment can be altered by maternal stress, depression, and anxiety, which
may affect the fetus during pregnancy. Also, antidepressant medications have been known to
cause complications for both the mother and fetus, which can make pregnancy a very difficult
time for women with a history of depression and anxiety. These women are more prone to
relapse during pregnancy, even if they previously recovered from the disorder. The purpose
of this study is to evaluate whether symptoms of depression and anxiety, during or soon
after pregnancy, affect an infant's social and emotional development.
Participation in this study will occur from early in the woman's pregnancy until her
infant's first birthday. Participants will attend at least eight study visits during
pregnancy and five study visits during the first year of the infant's life. Most study
visits will take place at the Emory University clinic on campus. During the first study
visit, participants will complete questionnaires regarding their current mood, stressors,
supports, experiences during pregnancy, symptoms of depression or anxiety, and any treatment
or medications they are currently receiving. Urine and blood will also be collected at the
initial visit. Follow-up visits, lasting 1 hour, will occur monthly until delivery. During
these visits, similar questionnaires will be administered and blood, urine, and saliva
samples will be collected. Uterine blood flow, fetal activity, and fetal heart rate will be
recorded at some follow-up visits. Women who undergo an amniocentesis will have the option
of providing a sample of amniotic fluid and an additional blood sample.
Immediately after delivery, blood from the baby's umbilical cord and blood from the mother
will be collected. A week after delivery, a home visit will be scheduled to assess each
mother's mood, stress, supports, delivery complications, and first impressions of the new
baby. At this time, a behavioral assessment will also be conducted on each infant, and
mothers will be observed while interacting with their child. At the infant's 6-month
pediatrician visit, a saliva sample will be taken to measure levels of cortisol and other
indicators of stress. Infants will be assessed at three other times before their first
birthday. During these assessments, the infant's ability to regulate his or her emotions
will be evaluated by videotaped behavioral observations, stress hormones from saliva, heart
rate, or recordings of brain activity through the use of either an electroencephalogram
(EEG) or event related potentials (ERP). Lastly, participants will be given the option to
provide a DNA sample for further analysis and future research. Fathers of the babies will be
included in selected study visits. Results from this study will be used to help prevent
emotional and social developmental problems in infants whose mothers have been diagnosed
with either depression or anxiety. |
| Criteria: |
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Inclusion Criteria:
- Meets DSM-IV criteria for major depressive disorder, panic disorder,
obsessive-compulsive disorder, generalized anxiety disorder, or post-traumatic stress
disorder
- Planning pregnancy or less than 16 weeks pregnant by last menstrual period
- Written and verbal fluency in English
- Known identity of biological father
Exclusion Criteria:
- Suicidal or homicidal
- Psychosis
- Meets DSM-IV criteria for bipolar disorder, schizophrenia, or an eating disorder
- Alcohol or substance abuse within 6 months prior to study start date
- Current illness requiring treatment that can influence outcomes (e.g., epilepsy,
asthma, autoimmune disorders)
- Abnormal thyroid stimulating hormone
- Anemic |
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| Study is available at: |
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Emory University Women's Mental Health Program
Atlanta, GA 30322
United States
Primary Contact:
Bettina T. Knight, BSN
Email: bknight@emory.edu
Phone: 404-778-2496
Secondary Contact:
Bettina T. Knight, RN, BSN
Email: bknight@emory.edu
Phone: 404-778-2496 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 15, 2010 |
Modifications to
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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