Status:
COMPLETED
Cognitive-Behavioral Therapy (CBT) in Women Discontinuing Antidepressant for Pregnancy
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Depression
Postpartum Depression
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The overarching goal of this study is to adapt a cognitive behavioral prevention of recurrence treatment (CBT-PR) for women with a history of recurrent major depressive disorder who decide to disconti...
Detailed Description
The current study is a small year-long pilot to collect data for a planned larger, randomized control trial in the future. The current protocol focuses on modifying a Cognitive-Behavioral Therapy (CBT...
Eligibility Criteria
Inclusion
- Subjects will include women 18 years and older who are either planning pregnancy or already pregnant and meet the following criteria:
- Currently meet criteria for stable remission from depression (defined as a baseline score of ≤ 9 on the Hamilton Rating Scale for Depression (HRSD) and documented clinical remission for a minimum of six months prior to randomization)
- Current or recent treatment with an antidepressant (stable dosage for at least the last four weeks)
- Have a history of a major depressive episode
- Decide to discontinue antidepressant medication for pregnancy
- Currently receive ongoing psychiatric care provided by a physician outside the MGH Center for Women's Mental Health, and written, informed consent.
Exclusion
- Significant risk for self-harm or harm to others
- Psychotic symptoms
- Meeting criteria for a primary SCID-I/P diagnosis of schizophrenia, bipolar disorder, an active eating disorder, dementia, delirium, or other cognitive disorder
- Presence of an active substance and/or alcohol abuse disorder within six months prior to screening visit
- Current use of mood stabilizers, antipsychotics or antiepileptics
- Have received cognitive-behavioral or interpersonal therapy within the last year
- Diagnosed with a medical disorder that has a known association with depressive symptoms (e. g. thyroid disorder).
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01453114
Start Date
November 1 2008
End Date
July 1 2012
Last Update
April 7 2015
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114