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NCT01260649 · ClinicalTrials.gov registry record · Phase 4

N-methyl-D-aspartate Antagonist (Ketamine) Augmentation of Electroconvulsive Treatment for Severe Major Depression

A Phase 4 study, sponsored by Massachusetts General Hospital.

Terminated
Registry status
Phase 4
Development phase
17
Enrollment target

NCT01260649: Clinical Trial Phase 4 study, sponsored by Massachusetts General Hospital.

NCT01260649 is a Phase 4 study that was terminated before completion, run by Massachusetts General Hospital. The registered enrollment target is 17 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01260649, a Phase 4 study, was terminated before completion, sponsored by Massachusetts General Hospital.

TERMINATED
Registry status
Phase 4
Development phase
17 participants
Enrollment target

Study Summary

Electroconvulsive therapy (ECT), is considered the most effective treatment for severe treatment resistant major depressive disorder (MDD), but it requires about 3 weeks of treatments and can cause considerable acute deficits in memory. It would be a major advance in treatment if ECT could work faster with fewer treatments and result in decrease incidence of memory problems. Ketamine is an excellent candidate for augmentation of ECT because of its acute effects on depression, its short half-life, and its safety profile when given at low doses. Ketamine is given as an infusion and could easily be incorporated into the routine management of patients undergoing ECT, but has never been evaluated prospectively in this context. The investigators propose to assess the efficacy, feasibility, tolerability and safety of N-methyl-D-aspartate antagonist augmentation of ECT using ketamine.

Primary Outcome

HAMD will be administered at every ECT treatment.The HAM D 28 is a 28 item scale with scores ranging from 0 to 83, with 0 being no depression and 83 being high levels of depression symptoms. The change in HAM S score was determined by the difference of the HAM D score at the last ECT administration and the baseline HAM D score. A negative change score reflects a decreased HAM D score between the first and last ECT administration and therefore a reduction in depressive symptoms.

Interventions

  • DRUG ketamine
  • PROCEDURE ECT
  • OTHER IV Saline
  • DRUG Muscle Relaxant
  • DRUG Anesthetic Agents

Trial Details

FieldValue
Enrollment Target 17 participants
Start Date 2010-11-01
Est. Completion 2012-11-01
Phase Phase 4
Massachusetts General Hospital

2,032 total trials

Why NCT01260649 stopped before completion

NCT01260649 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).

The record links to 0 conditions, and to 5 interventions - of which ketamine is the first listed.

NCT01260649 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01260649 about?

NCT01260649 is a clinical study titled "N-methyl-D-aspartate Antagonist (Ketamine) Augmentation of Electroconvulsive Treatment for Severe Major Depression". Electroconvulsive therapy (ECT), is considered the most effective treatment for severe treatment resistant major depressive disorder (MDD), but it requires about 3 weeks of treatments and can cause considerable acute deficits in memory. It would be a major advance in treatment if ECT could work fast...

What is the current status of trial NCT01260649?

This trial is currently terminated. It is a Phase 4 study. The enrollment target is 17 participants. The study started on 2010-11-01. Estimated completion is 2012-11-01.

What interventions are being tested in trial NCT01260649?

The interventions under investigation include: ketamine (DRUG), ECT (PROCEDURE), IV Saline (OTHER), Muscle Relaxant (DRUG), Anesthetic Agents (DRUG).

Who is sponsoring clinical trial NCT01260649?

This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01260649's enrollment target sits among peer trials

17 1854th of 2000 higher than 132 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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Source: ClinicalTrials.gov NCT01260649, the US trial registry maintained by the National Library of Medicine. NCT01260649 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.