Status:
COMPLETED
Group Interpersonal Psychotherapy for Treatment of Major Depressive Disorder Following Perinatal Loss
Lead Sponsor:
Brown University
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Major Depressive Disorder
Miscarriage
Eligibility:
FEMALE
18-50 years
Phase:
NA
Brief Summary
The purpose of this study is to conduct a randomized pilot trial in a sample of 60 women who meet criteria for Major Depressive Disorder (MDD) 1-18 months after a perinatal loss to demonstrate the fea...
Eligibility Criteria
Inclusion
- Current Major Depressive episode.
- Experience perinatal loss 1-18 months prior to intake (including early and late fetal death and the death of a live born neonate within the first 28 days).
Exclusion
- Untreated thyroid difficulties (TSH levels out of the normal range).
- Anemia (hemoglobin or hematocrit out of the normal range).
- Onset of current major depressive episode prior to news of difficulties with the pregnancy or health risk to the infant (women with prior episodes will be included).
- Current or past diagnosis of bipolar I disorder, schizophrenia or other psychotic disorder.
- Primary diagnosis of substance dependence or eating disorder.
- Acute suicidal or homicidal risk.
- Non-stable course of antidepressant medication or psychotherapy (i.e., beginning or changing dose of either within the previous 8 weeks).
- Any IPT or cognitive-behavioral treatment in the previous 8 weeks.
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT01867749
Start Date
June 1 2010
End Date
June 1 2014
Last Update
January 13 2016
Active Locations (1)
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1
Brown University
Providence, Rhode Island, United States, 02096