A Study of Medication With or Without Psychotherapy for Complicated Grief

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 condition (MH60783) and confirmed efficacy of a targeted psychotherapy,
complicated grief treatment (CGT). Participants in our prior study continued stable
antidepressant medication while receiving CGT or Interpersonal Psychotherapy (IPT).
Individuals taking antidepressants had better outcome in both treatments, though CGT was
superior to IPT when administered with (60% responders v. 40%) or without (42% v.19%)
antidepressants. Studies of antidepressant medication alone have shown mixed results with
SSRIs appearing to be promising. However, there has been no randomized controlled study of
SSRIs for CG. Determining the efficacy of SSRI treatment for CG, when administered with and
without CGT, is of great public health importance.

We assembled 4 groups of investigators with strong track records in bereavement research and
extensive experience with intervention studies and multicenter projects, to conduct a study
of citalopram (CIT) efficacy. We plan to enroll participants with a primary diagnosis of
Complicated Grief and randomly assign them (n=480; 50 at Columbia) to receive treatment with
CIT, Placebo (PBO), CIT + CGT or PBO + CGT over a period of approximately 16 weeks. We want
to determine whether citalopram shows a better response than placebo, when administered
either with or without CGT. We will also address the question of whether CIT performs as
well when administered alone as it does when administered with CGT.

Inclusion Criteria:

- 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 Criteria:

- 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