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WithdrawnNCT01557933Updated Nov 29, 2012

Effects of Electroconvulsive Therapy (ECT) in Bipolar Depression

An observational study in Bipolar Disorder, sponsored by Mclean Hospital. Withdrawn. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2012-11-29.

Sponsored by Mclean Hospital · Observational

Why this study was withdrawn
Due to a lack of participants, this study has been closed.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
0
Ages
18 Years to 55 Years
Sex
All
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Study summary

The primary purpose of this study is to use magnetic resonance spectroscopy (MRS) to measure the levels of several brain chemicals including, but not limited to, glutamate, glutamine, and N-acetylaspartate, before and after treatment with ECT. In addition to MRS, the investigators will use several other MRI techniques including structural MRI, resting state functional MRI (fMRI), and diffusion tensor imaging (DTI) to measure how the structure and function of the brain changes with ECT.

The investigators hypothesize that the Gln/Glu ratio is increased in the anterior cingulate cortex (ACC), but not the parieto-occipital cortex (POC), following the first ECT treatment.

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Conditions studied

  • Bipolar Disorder

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Keywords

  • ECT
  • Bipolar Disorder
03

In context

Bipolar Disorder

1,637 studies on the registry are indexed under Bipolar Disorder; 258 are open to participants now.

Browse Bipolar Disorder studies →

Lead sponsor

Mclean Hospital is the lead sponsor of 185 studies on the registry; 32 are open to participants now.

Of its 15 completed or terminated interventional studies of FDA-regulated products, 11 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Twelve study participants between the ages of 18-55 with will be recruited from inpatient units at McLean Hospital.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Male or female age 18-55
  • Meets DSM-IV criteria for Bipolar Disorder Type I, II, or NOS with current episode depressed
  • Has been scheduled to be evaluated by an ECT consultant from the McLean Hospital ECT service
  • Current score of greater than or equal to 24 on the Montgomery-Asberg Depression Rating Scale (MADRS)

Exclusion criteria

Exclusion Criteria:

  • Unwillingness or inability to provide informed consent
  • Lifetime history of schizophrenia
  • DSM-IV diagnosis of alcohol or substance dependence, with the exception of nicotine dependence, within three months prior to screening
  • Positive urine toxicology screen at screening (NOTE: Participants with a positive urine toxicology screen who are prescribed benzodiazepine, stimulant, or opiate medications by their physician will be permitted to enroll in the study as long as they do not meet abuse or dependence criteria for these substances)
  • Female participants with a positive urine pregnancy test at screening
  • Pregnancy. Females of childbearing potential must be using an effective contraceptive method (e.g., abstinence, prescription oral contraceptives, contraceptive injections, MRI-safe intrauterine device, double-barrier method, male partner sterilization)
  • Any contraindications to having an MRI scan, including cardiac pacemakers, metal vascular clips or stents, artificial heart valves, certain kinds of prostheses, brain stimulator devices, implanted drug pumps, ear implants, eye implants or known metal fragments in eyes, exposure to shrapnel or metal filings (wounded in military combat, sheetmetal workers, welders, and others), transdermal drug delivery systems, and certain tattoos with metallic ink. NOTE: Participants will be screened for these conditions at screening, and will be required to fill out a standard MRI screening form at the Brain Imaging Center, which will be reviewed by an MRI technician prior to each MRI scan
  • Scheduled to receive first ECT treatment on a Friday
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
0 participants (actual)

Groups and cohorts

  • ECT

    All study subjects have consented to receive ECT.

    Other: No interventions will be used

Interventions

  • OtherNo interventions will be used

    No interventions will be used

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What researchers measure

Primary outcomes

  1. Gln/Glu ratio following the first ECT treatment

    The Gln/Glu ratio is examined in the anterior cingulate cortex (ACC) and the parieto-occipital cortex (POC) following the first ECT treatment.

    Time frame: Participants will undergo an MR scan within 24 hours of their first ECT treatment

Secondary outcomes

  1. The Gln/Glu ratio following the sixth ECT treatment.

    The Gln/Glu ratio is examined in both the ACC and POC following the sixth ECT treatment.

    Time frame: Participants will undergo an MR scan within 24 hours of their sixth ECT treatment, which is approximately two weeks after their first ECT treatment

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 29, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01557933
Lead sponsor
Mclean Hospital
Responsible party
Brian P. Brennan, MD (Associate Director for Translational Neuroscience Research, Mclean Hospital) — Principal investigator
First posted
Mar 20, 2012
Start date
Apr 2011
Primary completion
Jul 2012
Completion
Jul 2012
Last update
Nov 29, 2012

Study contacts

Brian P Brennan, M.D.
principal investigator · Mclean Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Nov 2012. You cannot join it, but the record below documents what was studied.

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