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NCT01874951 · ClinicalTrials.gov registry record · Phase 2
Low-Dose Naltrexone (LDN) for Depression Relapse and Recurrence
A Phase 2 study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
NCT01874951: Completed Phase 2 study, sponsored by Massachusetts General Hospital.
NCT01874951 is a Phase 2 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 12 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01874951, a Phase 2 study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
Study Summary
The purpose of this pilot study is to determine if taking a low dose of naltrexone in addition to an antidepressant medication can help treat relapse or recurrence in people with Major Depressive Disorder (MDD). The U.S. Food and Drug Administration (FDA) has approved naltrexone for the treatment of alcohol dependence and opioid dependence, but the FDA has not approved naltrexone to treat depression. The investigators hypothesize that patients with breakthrough depression on an antidepressant regimen containing a pro-dopaminergic agent assigned to treatment with low dose naltrexone will demonstrate higher rates of response compared to those patients taking placebo.
Primary Outcome
Hamilton Depression Scale-17 (HAM-D-17) item. The change in scores depends on the difference between the initial (baseline) score and the final score at the conclusion of the double blind treatment period. There is no formal range of score changes, since they depend on the initial and final score. A negative score represents a lowering in the score from baseline to end (improvement), and a positive score indicates an increase in score from baseline to end (worsening). A zero score would indicate
Interventions
- DRUG Placebo
- DRUG Naltrexone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2013-06 |
| Est. Completion | 2015-06 |
| Phase | Phase 2 |
What the finished NCT01874951 record still lists
NCT01874951 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01874951 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01874951 about?
NCT01874951 is a clinical study titled "Low-Dose Naltrexone (LDN) for Depression Relapse and Recurrence". The purpose of this pilot study is to determine if taking a low dose of naltrexone in addition to an antidepressant medication can help treat relapse or recurrence in people with Major Depressive Disorder (MDD). The U.S. Food and Drug Administration (FDA) has approved naltrexone for the treatment of...
What is the current status of trial NCT01874951?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2013-06. Estimated completion is 2015-06.
What interventions are being tested in trial NCT01874951?
The interventions under investigation include: Placebo (DRUG), Naltrexone (DRUG).
Who is sponsoring clinical trial NCT01874951?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01874951's enrollment target sits among peer trials
12 1948th of 2000 higher than 34 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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