NCT01179568

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 the symptoms of complicated grief.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
395

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2010

Longer than P75 for phase_2

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 14, 2010

Completed
28 days until next milestone

First Posted

Study publicly available on registry

August 11, 2010

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

January 24, 2017

Completed
Last Updated

January 24, 2017

Status Verified

November 1, 2016

Enrollment Period

4.9 years

First QC Date

July 14, 2010

Results QC Date

September 6, 2016

Last Update Submit

November 28, 2016

Conditions

Complicated GriefBereavement

Keywords

GriefBereavementPsychotherapyMedicationTreatment study

Outcome Measures

Primary Outcomes (1)

  • Responder Status Based on Complicated Grief Clinical Global Impression-Improvement (CGI-I) Scale

    Brief rating scale frequently used in clinical trials. For this study, version modified for complicated grief was be used. Response is defined as a score of 1(very much improved) or 2 (much improved) on the scale. The rating was done by an Independent Evaluator.

    Weeks 12 and 20

Secondary Outcomes (4)

  • Change From Baseline in Inventory of Complicated Grief (ICG)

    Baseline and week 12

  • Change From Baseline in Inventory of Complicated Grief (ICG)

    Baseline and week 20

  • Change From Baseline in Work and Social Adjustment Scale (WSAS)

    Baseline and week 12

  • Change From Baseline in Work and Social Adjustment Scale (WSAS)

    Baseline and week 20

Study Arms (4)

CGT with Citalopram

ACTIVE COMPARATOR

Targeted psychotherapy for complicated grief will be combined with SSRI medication.

Drug: CitalopramBehavioral: Complicated Grief Treatment

Citalopram

ACTIVE COMPARATOR

Citalopram is an Selective Serotonin Reuptake Inhibitor (SSRI) medication. It will be combined with grief-focused clinical management.

Drug: Citalopram

Placebo (Sugar pill)

PLACEBO COMPARATOR

Inactive medication. It will be combined with grief-focused clinical management.

Other: Placebo

CGT with Placebo

ACTIVE COMPARATOR

The targeted psychotherapy for complicated grief will be combined with inactive medication.

Behavioral: Complicated Grief TreatmentOther: Placebo

Interventions

CitalopramDRUG

16 weeks of medication provided flexibly up to 40 mg/day. Medication will be administered in a double-blind fashion.

Also known as: Celexa
CGT with CitalopramCitalopram
Complicated Grief TreatmentBEHAVIORAL

Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.

Also known as: CGT
CGT with CitalopramCGT with Placebo
PlaceboOTHER

16 weeks of daily inactive medication. It will be administered in a double-blind fashion.

Also known as: Sugar pill
CGT with PlaceboPlacebo (Sugar pill)

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

VASDHS / University of California San Diego

San Diego, California, 92161, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (10)

  • Simon NM, Thompson EH, Pollack MH, Shear MK. Complicated grief: a case series using escitalopram. Am J Psychiatry. 2007 Nov;164(11):1760-1. doi: 10.1176/appi.ajp.2007.07050800. No abstract available.

    PMID: 17974946BACKGROUND

  • Shear K, Frank E, Houck PR, Reynolds CF 3rd. Treatment of complicated grief: a randomized controlled trial. JAMA. 2005 Jun 1;293(21):2601-8. doi: 10.1001/jama.293.21.2601.

    PMID: 15928281BACKGROUND

  • Schwartz D, Lellouch J. Explanatory and pragmatic attitudes in therapeutical trials. J Chronic Dis. 1967 Aug;20(8):637-48. doi: 10.1016/0021-9681(67)90041-0. No abstract available.

    PMID: 4860352BACKGROUND

  • Tunis SR, Stryer DB, Clancy CM. Practical clinical trials: increasing the value of clinical research for decision making in clinical and health policy. JAMA. 2003 Sep 24;290(12):1624-32. doi: 10.1001/jama.290.12.1624.

    PMID: 14506122BACKGROUND

  • Jacobs SC, Nelson JC, Zisook S. Treating depressions of bereavement with antidepressants. A pilot study. Psychiatr Clin North Am. 1987 Sep;10(3):501-10.

    PMID: 3684751BACKGROUND

  • Shear MK. Clinical practice. Complicated grief. N Engl J Med. 2015 Jan 8;372(2):153-60. doi: 10.1056/NEJMcp1315618. No abstract available.

    PMID: 25564898BACKGROUND

  • Calderon A, Irwin M, Simon NM, Shear MK, Mauro C, Zisook S, Reynolds CF 3rd, Malgaroli M. Depression is Associated with Treatment Response Trajectories in Adults with Prolonged Grief Disorder: A Machine Learning Analysis. medRxiv [Preprint]. 2024 Dec 12:2024.12.11.24318861. doi: 10.1101/2024.12.11.24318861.

    PMID: 39711702DERIVED

  • Na PJ, Adhikari S, Szuhany KL, Chen AZ, Suzuki RR, Malgaroli M, Robinaugh DJ, Bui E, Mauro C, Skritskaya NA, Lebowitz BD, Zisook S, Reynolds CF 3rd, Shear MK, Simon NM. Posttraumatic Distress Symptoms and Their Response to Treatment in Adults With Prolonged Grief Disorder. J Clin Psychiatry. 2021 Apr 20;82(3):20m13576. doi: 10.4088/JCP.20m13576.

    PMID: 34000119DERIVED

  • Zisook S, Shear MK, Reynolds CF, Simon NM, Mauro C, Skritskaya NA, Lebowitz B, Wang Y, Tal I, Glorioso D, Wetherell JL, Iglewicz A, Robinaugh D, Qiu X. Treatment of Complicated Grief in Survivors of Suicide Loss: A HEAL Report. J Clin Psychiatry. 2018 Mar/Apr;79(2):17m11592. doi: 10.4088/JCP.17m11592.

    PMID: 29617064DERIVED

  • Shear MK, Reynolds CF 3rd, Simon NM, Zisook S, Wang Y, Mauro C, Duan N, Lebowitz B, Skritskaya N. Optimizing Treatment of Complicated Grief: A Randomized Clinical Trial. JAMA Psychiatry. 2016 Jul 1;73(7):685-94. doi: 10.1001/jamapsychiatry.2016.0892.

    PMID: 27276373DERIVED

Related Links

MeSH Terms

Interventions

CitalopramSugars

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic ChemicalsNitrilesBenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsCarbohydrates

Limitations and Caveats

Two limitations of note: 1) FDA lowered the maximum safe dose of study medication (citalopram) after the study started; 2) our recruitment rate was 90% of target, while the assessment drop-out rate was over double what we expected.

Results Point of Contact

Title
M. Katherine Shear, MD
Organization
Columbia School of Social Work
ks2394@columbia.edu
212-851-2176

Study Officials

  • Katherine Shear, MD

    Columbia University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2010

First Posted

August 11, 2010

Study Start

March 1, 2010

Primary Completion

February 1, 2015

Study Completion

July 1, 2015

Last Updated

January 24, 2017

Results First Posted

January 24, 2017

Record last verified: 2016-11

Locations

US(4)