View Clinical Trial (Medical Research Study)
Infant Outcomes and Depression Treatment in Pregnancy
| City: |
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Ann Arbor |
| State: |
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Michigan |
| Zip Code: |
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48109 |
| Conditions: |
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Depression - Anxiety Disorders |
| Purpose: |
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This study will evaluate the impact of interpersonal psychotherapy on the course of
depression during and after pregnancy, as well as its effect on infant birth outcomes.
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| Study Summary: |
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Depression is a serious illness that affects a person's body, mood, and thoughts.
Researchers believe that it is one of the most common complications during and after
pregnancy. The following symptoms may be signs of depression during pregnancy: 2 or more
weeks of depressed mood; decreased interest or pleasure in activities; change in appetite or
sleep patterns; fatigue or decreased energy; difficulty concentrating; excessive feelings of
guilt or worthlessness; thoughts of suicide; and extreme restlessness or irritability.
Depression is difficult to diagnose during pregnancy because its symptoms are sometimes
confused with those of pregnancy. If left untreated, depression during pregnancy may affect
not only the mother, but also the baby. Specifically, the hormone changes brought on by
depression may contribute to premature and low-birth-weight infants. Interpersonal
psychotherapy (IPT) is a short-term talking therapy that has been proven to be effective in
treating depression. This study will evaluate the impact of interpersonal psychotherapy on
the course of depression during and after pregnancy, as well as its effect on infant birth
outcomes.
This study is associated with a larger parent study. Participants in this open-label study
may be recruited directly for this study or through the parent study. All participants will
receive 16 sessions of IPT. Sessions will last approximately 50 minutes and will focus on
achieving depression symptom remission by improving interpersonal functioning. The majority
of IPT sessions will be held prior to delivery; up to four sessions may be held postpartum.
No medication will be provided in this study, but women who are currently taking selective
serotonin uptake inhibitors (SSRIs) at the time of study entry may continue taking their
medication. Participants whose symptoms do not improve with IPT will be referred to their
non-study physician for further evaluation, and may begin taking SSRI medication upon
physician recommendation. The effects of both IPT and medication therapy will be considered
when assessing outcomes. Study visits will occur at 28, 32, and 36 weeks gestation, as well
as Weeks 1, 2, and 6, and Month 6 postpartum. Measurements will include cortisol levels,
which will be obtained using a saliva sample, as well as depression symptom severity, which
will be assessed at each IPT session. Blood samples will be taken as part of the parent
study.
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| Criteria: |
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Inclusion Criteria:
- No more than 28 weeks pregnant at the time of study entry
- History of depression or anxiety
- Current symptoms of distress
- Score of 9 or greater on the Edinburgh Postnatal Depression Scale (EPDS)
- English-speaking
Exclusion Criteria:
- Plans to move away from the area prior to giving birth
- Current use of steroids for medical conditions
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| NCT ID: |
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NCT00380419 |
| Primary Contact: |
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Principal Investigator
Sheila M. Marcus, MD
Universitiy of Michigan
Katherine H. Bullard, MSW, MPH
Phone: 734-763-4904
Email: krharris@umich.edu
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| Backup Contact: |
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Email: sueileen@umich.edu
Susan E. Hamilton, MS
Phone: 734-615-6493
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| Location Contact: |
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Ann Arbor, Michigan 48109
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 20, 2013 |
| Modifications to this listing: |
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