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Effects of Electroconvulsive Therapy (ECT) in Bipolar Depression

This study has been withdrawn prior to enrollment.
(Due to a lack of participants, this study has been closed.)
Sponsor:
Information provided by (Responsible Party):
Brian P. Brennan, MD, Mclean Hospital
ClinicalTrials.gov Identifier:
NCT01557933
First received: March 9, 2012
Last updated: November 28, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention
Bipolar Disorder
Other: No interventions will be used

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Study of the Acute and Chronic Effects of Electroconvulsive Therapy on Glutamatergic Neurotransmission in Bipolar Depression

Resource links provided by NLM:


Further study details as provided by Mclean Hospital:

Primary Outcome Measures:
  • Gln/Glu ratio following the first ECT treatment [ Time Frame: Participants will undergo an MR scan within 24 hours of their first ECT treatment ] [ Designated as safety issue: No ]
    The Gln/Glu ratio is examined in the anterior cingulate cortex (ACC) and the parieto-occipital cortex (POC) following the first ECT treatment.


Secondary Outcome Measures:
  • The Gln/Glu ratio 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 ] [ Designated as safety issue: No ]
    The Gln/Glu ratio is examined in both the ACC and POC following the sixth ECT treatment.


Enrollment: 0
Study Start Date: April 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
ECT
All study subjects have consented to receive ECT.
Other: No interventions will be used
No interventions will be used

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01557933

Sponsors and Collaborators
Mclean Hospital
Investigators
Principal Investigator: Brian P Brennan, M.D. Mclean Hospital
  More Information

No publications provided

Responsible Party: Brian P. Brennan, MD, Associate Director for Translational Neuroscience Research, Mclean Hospital
ClinicalTrials.gov Identifier: NCT01557933     History of Changes
Other Study ID Numbers: 2011-P-000693
Study First Received: March 9, 2012
Last Updated: November 28, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Mclean Hospital:
ECT
Bipolar Disorder

Additional relevant MeSH terms:
Bipolar Disorder
Depression
Affective Disorders, Psychotic
Behavioral Symptoms
Mental Disorders
Mood Disorders

ClinicalTrials.gov processed this record on November 20, 2014