Phase 2
Completed N=395
A Study of Medication With or Without Psychotherapy for Complicated Grief
Complicated Grief · Bereavement
Source: ClinicalTrials.gov NCT01179568 ↗
Enrolled (actual)
395
Serious AEs
0.3%
Results posted
Jan 2017
Primary outcomePrimary: Responder Status Based on Complicated Grief Clinical Global Impression-Improvement (CGI-I) Scale — 46; 38; 84; 83 percentage of responders — p=<0.05
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 the symptoms of complicated grief.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Responder Status Based on Complicated Grief Clinical Global Impression-Improvement (CGI-I) Scale |
46; 38; 84; 83 | <0.05 sig |
| SECONDARY Change From Baseline in Inventory of Complicated Grief (ICG) |
20; 25; 26 | .53 |
| SECONDARY Change From Baseline in Work and Social Adjustment Scale (WSAS) |
10; 14; 16 | .40 |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01179568). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.