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Effects of Electroconvulsive Therapy (ECT) in Bipolar Depression

NCT ID: NCT01557933

Last Updated: 2012-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2011-04-30

Study Completion Date

2012-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Bipolar Disorder

Keywords

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ECT Bipolar Disorder

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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ECT

All study subjects have consented to receive ECT.

No interventions will be used

Intervention Type OTHER

No interventions will be used

Interventions

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No interventions will be used

No interventions will be used

Intervention Type OTHER

Eligibility Criteria

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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

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mclean Hospital

OTHER

Sponsor Role lead

Responsible Party

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Brian P. Brennan, MD

Associate Director for Translational Neuroscience Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Brian P Brennan, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mclean Hospital

Countries

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United States

Other Identifiers

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2011-P-000693

Identifier Type: -

Identifier Source: org_study_id