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NCT01312844 · ClinicalTrials.gov registry record · Phase 2
A Study of the Use of IV Scopolamine to Augment the Efficacy of Electroconvulsive Therapy (ECT)
A Phase 2 study, sponsored by Massachusetts General Hospital.
- Terminated
- Registry status
- Phase 2
- Development phase
- 7
- Enrollment target
NCT01312844: Clinical Trial Phase 2 study, sponsored by Massachusetts General Hospital.
NCT01312844 is a Phase 2 study that was terminated before completion, run by Massachusetts General Hospital. The registered enrollment target is 7 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01312844, a Phase 2 study, was terminated before completion, sponsored by Massachusetts General Hospital.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 7 participants
- Enrollment target
Study Summary
The primary purpose of this study is to assess the ability of scopolamine to improve the antidepressant effects of ECT and to determine whether scopolamine will shorten the time to response and remission for patients receiving ECT. The hypothesis are: 1. Patients receiving ECT plus scopolamine will have greater improvement in depression symptoms than those receiving ECT plus placebo. 2. Patients receiving scopolamine in addition to ECT will require fewer ECT treatments to obtain response/remission compared to the group receiving ECT plus placebo. 3. Time to response and to remission in the scopolamine group will be significantly shorter compared to ECT alone.
Primary Outcome
Change in Ham D 17 scores measured by the difference between baseline HAM D score and HAM D score at last ECT administration. The HAM D 17 measures severity of depression with 52 being most severe and 0 being no depression. A negative change score refers to a decrease in HAM D score, while a positive change score would refer to an increase in HAM D score.
Interventions
- DRUG Scopolamine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2010-04 |
| Est. Completion | 2012-07 |
| Phase | Phase 2 |
Why NCT01312844 stopped before completion
NCT01312844 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which Scopolamine is the first listed.
NCT01312844 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01312844 about?
NCT01312844 is a clinical study titled "A Study of the Use of IV Scopolamine to Augment the Efficacy of Electroconvulsive Therapy (ECT)". The primary purpose of this study is to assess the ability of scopolamine to improve the antidepressant effects of ECT and to determine whether scopolamine will shorten the time to response and remission for patients receiving ECT. The hypothesis are: 1. Patients receiving ECT plus scopolamine wil...
What is the current status of trial NCT01312844?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 7 participants. The study started on 2010-04. Estimated completion is 2012-07.
What interventions are being tested in trial NCT01312844?
The interventions under investigation include: Scopolamine (DRUG).
Who is sponsoring clinical trial NCT01312844?
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 NCT01312844's enrollment target sits among peer trials
7 1996th of 2000 higher than 5 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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