Status:
COMPLETED
A Study of Medication With or Without Psychotherapy for Complicated Grief
Lead Sponsor:
New York State Psychiatric Institute
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
American Foundation for Suicide Prevention
Conditions:
Complicated Grief
Bereavement
Eligibility:
All Genders
18-95 years
Phase:
PHASE2
Brief Summary
The major goal of this 4-site, double blind, placebo-controlled intervention trial is to assess the efficacy of medication (Citalopram) alone or with psychotherapy (Complicated Grief Therapy) to treat...
Detailed Description
Complicated grief (CG) is a debilitating condition that is estimated to affect millions of people in the United States alone. We conducted the first randomized controlled study to address this conditi...
Eligibility Criteria
Inclusion
- Diagnosed with Complicated Grief and this is the patient's most important (primary) problem
- Ability to give informed consent
- Fluent in English
- Willingness to have sessions audiotaped
- Willingness to undergo random assignment
Exclusion
- Diagnosis of one or more of the following disorders: Schizophrenia or other psychotic disorder, current (past 6 months) substance abuse, Bipolar Disorder, current manic episode, Dementia
- Pregnant or lactating women and women of childbearing potential not using medically accepted forms of contraception
- Acute, unstable or severe medical illness such as (but not limited to) stroke, epilepsy, or other neurodegenerative disorders, metastatic or active cancer, hepatic disease, or primary renal disease requiring dialysis
- Prior intolerance of citalopram
- Pending or active disability claim or lawsuit related to the death
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
395 Patients enrolled
Trial Details
Trial ID
NCT01179568
Start Date
March 1 2010
End Date
July 1 2015
Last Update
January 24 2017
Active Locations (4)
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1
VASDHS / University of California San Diego
San Diego, California, United States, 92161
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
3
New York State Psychiatric Institute
New York, New York, United States, 10032
4
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213