Trial · NCT01179568
A Study of Medication With or Without Psychotherapy for Complicated Grief
NCT01179568, Phase 2, Completed, New York State Psychiatric Institute; results first posted 2017-01-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Medication With or Without Psychotherapy for Complicated Grief. Trials, record NCT01179568. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01179568
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Medication With or Without Psychotherapy for Complicated Grief
- NCT number
- NCT01179568
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 395 participants, actual
- Lead sponsor
- New York State Psychiatric Institute
- Conditions
- Complicated Grief, Bereavement
- Interventions
- Citalopram, Complicated Grief Treatment, Placebo
- First posted
- 2010-08-11
- Last updated
- 2017-01-24
- Results first posted
- 2017-01-24
- 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.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Responder Status Based on Complicated Grief Clinical Global Impression-Improvement (CGI-I) Scale | Weeks 12 and 20 | 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. |
| Secondary | Change From Baseline in Inventory of Complicated Grief (ICG) | Baseline and week 12 | The 19-item self-report instrument assesses symptoms of complicated grief. Responses on individual items are added up to a total score, which can range from 0 to 76 with higher scores indicating more intense symptoms. This scale has been utilized previously in treatment studies of CG. Additional times points include weeks 4, 8, 12, 16, 20 and 40. For the pre-specified analyses we compared change in the ICG total score from baseline (calculated as baseline score minus week 12 score) for CIT vs PLA at week 12 (aim 1), based on the intention-to-treat principle including all randomized participants. |
| Secondary | Change From Baseline in Inventory of Complicated Grief (ICG) | Baseline and week 20 | The 19-item self-report instrument assesses symptoms of complicated grief. Responses on individual items are added up to a total score, which can range from 0 to 76 with higher scores indicating more intense symptoms. This scale has been utilized previously in treatment studies of CG. Additional times points include weeks 4, 8, 12, 16, 20 and 40. For the pre-specified analyses we compared change in the ICG total score from baseline (calculated as baseline score minus week 20 score) for CIT with CGT vs PLA with CGT (aim 2), and for CIT with CGT vs CIT (aim 3) based on the intention-to-treat principle including all randomized participants. |
| Secondary | Change From Baseline in Work and Social Adjustment Scale (WSAS) | Baseline and week 12 | The WSAS is a modification of a scale introduced by Hafner and Marks (1976), consisting of 0-8 point ratings of the extent to which symptoms interfere with five areas of daily functioning: work, home management, private leisure, social leisure, and family relationships. It is a well-validated, widely used self-report measure. Additional time points include weeks 4, 8, 12, 16, and 40. A total score calculated as a sum of all items (possible range 0-40) was used in the analyses with higher scores indicating more impairment. For the pre-specified analyses we compared change in the WSAS total score from baseline (calculated as baseline score minus week 12 score) for CIT vs PLA at week 12 (aim 1), based on the intention-to-treat principle including all randomized participants. |
| Secondary | Change From Baseline in Work and Social Adjustment Scale (WSAS) | Baseline and week 20 | The WSAS is a modification of a scale introduced by Hafner and Marks (1976), consisting of 0-8 point ratings of the extent to which symptoms interfere with five areas of daily functioning: work, home management, private leisure, social leisure, and family relationships. It is a well-validated, widely used self-report measure. Additional time points include weeks 4, 8, 12, 16, and 40. A total score calculated as a sum of all items (possible range 0-40) was used in the analyses with higher scores indicating more impairment. For the pre-specified analyses we compared change in the WSAS total score from baseline (calculated as baseline score minus week 20 score) for CIT with CGT vs PLA with CGT (aim 2), and for CIT with CGT vs CIT (aim 3) based on the intention-to-treat principle including all randomized participants. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Responder Status Based on Complicated Grief Clinical Global Impression-Improvement (CGI-I) Scale | Weeks 12 and 20 | Response rates were compared under the intention-to-treat principle, including all randomized participants in a logistic regression with inverse probability weighting . | percentage of responders | NUMBER |
| SECONDARY | Change From Baseline in Inventory of Complicated Grief (ICG) | Baseline and week 12 | Prespecified secondary analyses of self-report ratings of CG symptoms (ICG) compared changes in scores using a weighted linear regression with inverse probability weighting to adjust for missing assessments. | score change from baseline to wk12 | MEAN |
| SECONDARY | Change From Baseline in Inventory of Complicated Grief (ICG) | Baseline and week 20 | Prespecified secondary analyses of self-report ratings of CG symptoms (ICG) compared changes in scores using a weighted linear regression with inverse probability weighting to adjust for missing assessments. | score change from baseline to wk20 | MEAN |
| SECONDARY | Change From Baseline in Work and Social Adjustment Scale (WSAS) | Baseline and week 12 | Prespecified secondary analyses of self-report ratings of grief-related functional impairment (WSAS) compared changes in scores using a weighted linear regression with inverse probability weighting to adjust for missing assessments. | score change from baseline to wk12 | MEAN |
| SECONDARY | Change From Baseline in Work and Social Adjustment Scale (WSAS) | Baseline and week 20 | Prespecified secondary analyses of self-report ratings of grief-related functional impairment (WSAS) compared changes in scores using a weighted linear regression with inverse probability weighting to adjust for missing assessments. | score change from baseline to wk20 | MEAN |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Responder Status Based on Complicated Grief Clinical Global Impression-Improvement (CGI-I) Scale | Citalopram (CIT) | 46 | percentage of responders | ||
| Responder Status Based on Complicated Grief Clinical Global Impression-Improvement (CGI-I) Scale | Placebo (PLA; Sugar Pill) | 38 | percentage of responders | ||
| Responder Status Based on Complicated Grief Clinical Global Impression-Improvement (CGI-I) Scale | Complicated Grief Treatment With Citalopram (CGT With CIT) | 84 | percentage of responders | ||
| Responder Status Based on Complicated Grief Clinical Global Impression-Improvement (CGI-I) Scale | Complicated Grief Treatment With Placebo (CGT With PLA) | 83 | percentage of responders | ||
| Change From Baseline in Inventory of Complicated Grief (ICG) | Citalopram (CIT) | 18 | Standard Deviation 11 | score change from baseline to wk12 | |
| Change From Baseline in Inventory of Complicated Grief (ICG) | Placebo (PLA; Sugar Pill) | 16 | Standard Deviation 12 | score change from baseline to wk12 | |
| Change From Baseline in Inventory of Complicated Grief (ICG) | Citalopram (CIT) | 20 | Standard Deviation 12 | score change from baseline to wk20 | |
| Change From Baseline in Inventory of Complicated Grief (ICG) | Complicated Grief Treatment With Citalopram (CGT With CIT) | 25 | Standard Deviation 14 | score change from baseline to wk20 | |
| Change From Baseline in Inventory of Complicated Grief (ICG) | Complicated Grief Treatment With Placebo (CGT With PLA) | 26 | Standard Deviation 12 | score change from baseline to wk20 | |
| Change From Baseline in Work and Social Adjustment Scale (WSAS) | Citalopram (CIT) | 10 | Standard Deviation 11 | score change from baseline to wk12 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Citalopram | 101 | |
| Overall Study | STARTED | Placebo (Sugar Pill) | 99 | |
| Overall Study | STARTED | CGT With Citalopram | 99 | |
| Overall Study | STARTED | CGT With Placebo | 96 | |
| Overall Study | Completed Week 12 Assessment | Citalopram | 69 | |
| Overall Study | Completed Week 12 Assessment | Placebo (Sugar Pill) | 69 | |
| Overall Study | Completed Week 12 Assessment | CGT With Citalopram | 76 | |
| Overall Study | Completed Week 12 Assessment | CGT With Placebo | 75 | |
| Overall Study | COMPLETED | Citalopram | 73 | |
| Overall Study | COMPLETED | Placebo (Sugar Pill) | 61 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | death by suicide | Injury, poisoning and procedural complications | Citalopram | 0 | 101 | 0 |
| serious | death by suicide | Injury, poisoning and procedural complications | Placebo (Sugar Pill) | 0 | 99 | 0 |
| serious | death by suicide | Injury, poisoning and procedural complications | CGT With Citalopram | 1 | 99 | 1 |
| serious | death by suicide | Injury, poisoning and procedural complications | CGT With Placebo | 0 | 96 | 0 |
Source ClinicalTrials.gov
Adverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Citalopram | ||
| Total, all-cause mortality | Placebo (Sugar Pill) | ||
| Total, all-cause mortality | CGT With Citalopram | ||
| Total, all-cause mortality | CGT With Placebo | ||
| Total, other adverse events | Citalopram | 0 | 101 |
| Total, other adverse events | Placebo (Sugar Pill) | 0 | 99 |
| Total, other adverse events | CGT With Citalopram | 0 | 99 |
| Total, other adverse events | CGT With Placebo | 0 | 96 |
| Total, serious adverse events | Citalopram | 0 | 101 |
| Total, serious adverse events | Placebo (Sugar Pill) | 0 | 99 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers10
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01MH060783 | 1/4-Optimizing Treatment for Complicated Grief | SHEAR, M KATHERINE; DUAN, NAIHUA | COLUMBIA UNIVERSITY HEALTH SCIENCES | NATIONAL INSTITUTE OF MENTAL HEALTH | 2000 to 2016 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01179568
GET https://conductscience.org/api/trials/v1/NCT01179568/registered