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We are terminating the study due to low accrual.
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This is a study to see how effective oral naltrexone is as treatment for prolonged grief disorder (PGD). Participants will take their assigned medication for 8 weeks, with monthly visits to assess symptom severity, social connectedness, and adverse reactions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | 24 randomized patients will take placebo daily for 8 weeks. |
|
| Naltrexone | Active Comparator | 24 randomized patients will take naltrexone daily for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naltrexone HCl 50 MG Oral Tablet | Drug | Generic, oral tablet. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Prolonged Grief Disorder Symptom Severity as Assessed by Prolonged Grief-13 (PG-13) | Prolonged Grief Disorder (PGD) is a newly defined syndrome that is a specific reaction to the loss of a loved one. Change in PGD symptom severity will be measured by using Prolonged Grief-13-R (PG-13-R), a self-rated scale consisting of 11 items. The validity and reliability of the scale were tested and validated in previous studies. Minimum Score: 11 - reflecting the lowest level of PGD symptom severity (distress) Maximum Score: 55 - reflecting the highest level of PGD symptom severity (distress) Diagnostic Criteria PGD symptom severity of ≥30 is the threshold for "syndromal" level PGD. Prolonged Grief (PG-13-R) is a diagnostic tool. If a respondent meets the diagnostic criteria for PGD, this suggests that they should seek more thorough evaluation from a mental health professional. Only an in-person assessment by a mental health professional can determine for certain the clinical significance of the reported symptoms, and provide recommendations or referrals for treatment. | Baseline and 8 Weeks |
| Change in Prolonged Grief Disorder Symptom Severity as Assessed by Prolonged Grief-13 | Prolonged Grief Disorder (PGD) is a newly defined syndrome that is a specific reaction to the loss of a loved one. Change in PGD symptom severity will be measured by using Prolonged Grief-13-R (PG-13-R), a self-rated scale consisting of 11 items. The validity and reliability of the scale were tested and validated in previous studies. Minimum Score: 11 - reflecting the lowest level of PGD symptom severity (distress) Maximum Score: 55 - reflecting the highest level of PGD symptom severity (distress) Diagnostic Criteria PGD symptom severity of ≥30 is the threshold for "syndromal" level PGD. Prolonged Grief (PG-13-R) is a diagnostic tool. If a respondent meets the diagnostic criteria for PGD, this suggests that they should seek more thorough evaluation from a mental health professional. Only an in-person assessment by a mental health professional can determine for certain the clinical significance of the reported symptoms, and provide recommendations or referrals for treatment. | Baseline and 12 weeks |
| Change in Number of Participants With Prolonged Grief Disorder as Assessed by Structured Clinical Interview for PGD (SCIP) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Strength of Subjectively Perceived Closeness of a Social Relationship as Measured by the Inclusion of the Other in the Self (IOS) Scale | The Inclusion of Other in the Self (IOS) Scale is a self-reported pictorial tool used to measure the subjectively perceived closeness of a relationship. Respondents choose a pair of seven circles with different degrees of overlap. 1=no overlap; 2=little overlap; 3=some overlap; 4=equal overlap; 5=strong overlap; 6=very strong overlap; 7=most overlap. The tool asks respondents to select one of seven pairs of increasingly overlapping circles that best represent their relationship with another, with more overlap signifying a closer relationship. This scale possesses good reliability, with (α=.93) for the entire sample, (α=.87) for family, (α=.92) for friendship, and (α=.95) for romantic relationships. Test-retest reliability shows similar findings, with (α=.83) for the entire sample, (α=.85) for family, (α=.86) for friendship, and (α=.85) for romantic relationships. Minimum Score: 1 - reflecting the least amount of overlap Maximum Score: 7 - reflecting the most amount of overlap |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Holly G Prigerson, PhD | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Medicine | New York | New York | 10021 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32629197 | Background | Kakarala SE, Roberts KE, Rogers M, Coats T, Falzarano F, Gang J, Chilov M, Avery J, Maciejewski PK, Lichtenthal WG, Prigerson HG. The neurobiological reward system in Prolonged Grief Disorder (PGD): A systematic review. Psychiatry Res Neuroimaging. 2020 Sep 30;303:111135. doi: 10.1016/j.pscychresns.2020.111135. Epub 2020 Jul 3. | |
| 33522931 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | 24 randomized patients will take placebo daily for 8 weeks. Placebo: Composed of filler material and encapsulated to appear identical to naltrexone. |
| FG001 | Naltrexone | 24 randomized patients will take naltrexone daily for 8 weeks Naltrexone HCl 50 MG Oral Tablet: Generic, oral tablet. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1st Clinic Visit (1 Week) |
| |||||||||||||
| 2nd Clinic Visit (4 Weeks) |
| |||||||||||||
| 3rd Clinic Visit (8 Weeks) |
| |||||||||||||
| Follow Up (12 Weeks) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | 24 randomized patients will take placebo daily for 8 weeks. Placebo: Composed of filler material and encapsulated to appear identical to naltrexone. |
| BG001 | Naltrexone |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Prolonged Grief Disorder Symptom Severity as Assessed by Prolonged Grief-13 (PG-13) | Prolonged Grief Disorder (PGD) is a newly defined syndrome that is a specific reaction to the loss of a loved one. Change in PGD symptom severity will be measured by using Prolonged Grief-13-R (PG-13-R), a self-rated scale consisting of 11 items. The validity and reliability of the scale were tested and validated in previous studies. Minimum Score: 11 - reflecting the lowest level of PGD symptom severity (distress) Maximum Score: 55 - reflecting the highest level of PGD symptom severity (distress) Diagnostic Criteria PGD symptom severity of ≥30 is the threshold for "syndromal" level PGD. Prolonged Grief (PG-13-R) is a diagnostic tool. If a respondent meets the diagnostic criteria for PGD, this suggests that they should seek more thorough evaluation from a mental health professional. Only an in-person assessment by a mental health professional can determine for certain the clinical significance of the reported symptoms, and provide recommendations or referrals for treatment. | Four participants had dropped out of the study, and therefore, the required data for analysis was not collected. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 8 Weeks |
2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | 24 randomized patients will take placebo daily for 8 weeks. Placebo: Composed of filler material and encapsulated to appear identical to naltrexone. |
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Due to low accrual, only descriptive statistics are presented.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Holly G. Prigerson | Weill Cornell Medicine | 646-962-9655 | hgp2001@med.cornell.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 18, 2021 | Jun 28, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000090382 | Prolonged Grief Disorder |
| ID | Term |
|---|---|
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D009271 | Naltrexone |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D009270 | Naloxone |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 |
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| Placebo |
| Drug |
Composed of filler material and encapsulated to appear identical to naltrexone. |
|
Eligibility for the study and change in symptom severity will be measured by SCIP. This structured clinical interview is adapted to the DSM-5-TR criteria for PGD. Interviewers will be trained to standard which will be a κ > 0.8 agreement between trainee and trainer. |
| Every 4 weeks for 8 weeks |
| Every 4 weeks for 12 weeks |
| Gang J, Kocsis J, Avery J, Maciejewski PK, Prigerson HG. Naltrexone treatment for prolonged grief disorder: study protocol for a randomized, triple-blinded, placebo-controlled trial. Trials. 2021 Feb 1;22(1):110. doi: 10.1186/s13063-021-05044-8. |
| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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24 randomized patients will take naltrexone daily for 8 weeks
Naltrexone HCl 50 MG Oral Tablet: Generic, oral tablet.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Placebo | 24 randomized patients will take placebo daily for 8 weeks. Placebo: Composed of filler material and encapsulated to appear identical to naltrexone. |
| OG001 | Naltrexone | 24 randomized patients will take naltrexone daily for 8 weeks Naltrexone HCl 50 MG Oral Tablet: Generic, oral tablet. |
|
|
| Primary | Change in Prolonged Grief Disorder Symptom Severity as Assessed by Prolonged Grief-13 | Prolonged Grief Disorder (PGD) is a newly defined syndrome that is a specific reaction to the loss of a loved one. Change in PGD symptom severity will be measured by using Prolonged Grief-13-R (PG-13-R), a self-rated scale consisting of 11 items. The validity and reliability of the scale were tested and validated in previous studies. Minimum Score: 11 - reflecting the lowest level of PGD symptom severity (distress) Maximum Score: 55 - reflecting the highest level of PGD symptom severity (distress) Diagnostic Criteria PGD symptom severity of ≥30 is the threshold for "syndromal" level PGD. Prolonged Grief (PG-13-R) is a diagnostic tool. If a respondent meets the diagnostic criteria for PGD, this suggests that they should seek more thorough evaluation from a mental health professional. Only an in-person assessment by a mental health professional can determine for certain the clinical significance of the reported symptoms, and provide recommendations or referrals for treatment. | Four participants had dropped out of the study, and therefore, the required data for analysis was not collected. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 12 weeks |
|
|
|
| Primary | Change in Number of Participants With Prolonged Grief Disorder as Assessed by Structured Clinical Interview for PGD (SCIP) | Eligibility for the study and change in symptom severity will be measured by SCIP. This structured clinical interview is adapted to the DSM-5-TR criteria for PGD. Interviewers will be trained to standard which will be a κ > 0.8 agreement between trainee and trainer. | Four participants had dropped out of the study, and therefore, the required data for analysis was not collected. | Posted | Count of Participants | Participants | Every 4 weeks for 8 weeks |
|
|
|
| Secondary | Change in Strength of Subjectively Perceived Closeness of a Social Relationship as Measured by the Inclusion of the Other in the Self (IOS) Scale | The Inclusion of Other in the Self (IOS) Scale is a self-reported pictorial tool used to measure the subjectively perceived closeness of a relationship. Respondents choose a pair of seven circles with different degrees of overlap. 1=no overlap; 2=little overlap; 3=some overlap; 4=equal overlap; 5=strong overlap; 6=very strong overlap; 7=most overlap. The tool asks respondents to select one of seven pairs of increasingly overlapping circles that best represent their relationship with another, with more overlap signifying a closer relationship. This scale possesses good reliability, with (α=.93) for the entire sample, (α=.87) for family, (α=.92) for friendship, and (α=.95) for romantic relationships. Test-retest reliability shows similar findings, with (α=.83) for the entire sample, (α=.85) for family, (α=.86) for friendship, and (α=.85) for romantic relationships. Minimum Score: 1 - reflecting the least amount of overlap Maximum Score: 7 - reflecting the most amount of overlap | Four participants had dropped out of the study, and therefore, the required data for analysis was not collected. | Posted | Mean | Standard Deviation | score on a scale | Every 4 weeks for 12 weeks |
|
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|
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Naltrexone | 24 randomized patients will take naltrexone daily for 8 weeks Naltrexone HCl 50 MG Oral Tablet: Generic, oral tablet. | 0 | 3 | 0 | 3 | 0 | 3 |
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| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| 12 weeks |
|