Effects of Electroconvulsive Therapy (ECT) in Bipolar Depression

NCT01557933 | Withdrawn

• 1 other identifier: 2011-P-000693
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Bipolar Disorder

Keywords

ECT; Bipolar Disorder

Outcome Measures

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.

  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.

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

Study Arms (1)

ECT

All study subjects have consented to receive ECT.

Other: No interventions will be used

Interventions

No interventions will be used OTHER

No interventions will be used

ECT

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Mclean Hospital: lead

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Study Officials

• Brian P Brennan, M.D.

  Mclean Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Director for Translational Neuroscience Research

Study Record Dates

• First Submitted: March 9, 2012
• First Posted: March 20, 2012
• Study Start: April 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: November 29, 2012

Record last verified: 2012-11