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NCT04547985 · ClinicalTrials.gov registry record · Phase 4
Naltrexone Treatment for Prolonged Grief Disorder (PGD)
A Phase 4 study, sponsored by Weill Medical College of Cornell University.
- Terminated
- Registry status
- Phase 4
- Development phase
- 9
- Enrollment target
NCT04547985: Clinical Trial Phase 4 study, sponsored by Weill Medical College of Cornell University.
NCT04547985 is a Phase 4 study that was terminated before completion, run by Weill Medical College of Cornell University. The registered enrollment target is 9 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04547985, a Phase 4 study, was terminated before completion, sponsored by Weill Medical College of Cornell University.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 9 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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 (distre
Interventions
- DRUG Placebo
- DRUG Naltrexone HCl 50 MG Oral Tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2021-01-05 |
| Est. Completion | 2023-10-16 |
| Phase | Phase 4 |
Why NCT04547985 stopped before completion
NCT04547985 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04547985 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04547985 about?
NCT04547985 is a clinical study titled "Naltrexone Treatment for Prolonged Grief Disorder (PGD)". 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.
What is the current status of trial NCT04547985?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 9 participants. The study started on 2021-01-05. Estimated completion is 2023-10-16.
What interventions are being tested in trial NCT04547985?
The interventions under investigation include: Placebo (DRUG), Naltrexone HCl 50 MG Oral Tablet (DRUG).
Who is sponsoring clinical trial NCT04547985?
This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04547985's enrollment target sits among peer trials
9 1968th of 2000 higher than 29 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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