Bipolar DisorderNCT01557933
Effects of Electroconvulsive Therapy (ECT) in Bipolar Depression
An observational study of Bipolar Disorder, run by Mclean Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Bipolar Disorder
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2011to Jul 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: Twelve study participants between the ages of 18-55 with will be recruited from inpatient units at McLean Hospital.
Who may be able to join
- 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)
Who cannot join
- 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
About this study
Official title: A Study of the Acute and Chronic Effects of Electroconvulsive Therapy on Glutamatergic Neurotransmission in Bipolar Depression
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
- Being tested
- No interventions will be used
- Keywords
- ECT, Bipolar Disorder
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventions will be usedOther
No interventions will be used
| Study group | Role | What they receive |
|---|---|---|
| ECT | All study subjects have consented to receive ECT. Receives: Other: No interventions will be used |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Participants will undergo an MR scan within 24 hours of their sixth ECT treatment, which is approximately two weeks after their first ECT treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2012 (estimated)
- Study startApr 2011
- Primary completionJul 2012
- Study completionJul 2012
Why it stopped: Due to a lack of participants, this study has been closed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mclean Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian P. Brennan, MD, Mclean Hospital
- Investigators
- Brian P Brennan, M.D., Principal investigator, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01557933
- Sponsor's protocol ID
- 2011-P-000693
- Status last verified
- Nov 2012
- First submitted
- 9 Mar 2012
- Last updated
- 29 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Acute and Chronic Effects of Electroconvulsive Therapy on Glutamatergic Neurotransmission in Bipolar Depression
- ClinicalTrials.gov ID
- NCT01557933
- Acronym / sponsor ID
- 2011-P-000693
- Conditions
- Bipolar Disorder
- Keywords
- ECT, Bipolar Disorder
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Due to a lack of participants, this study has been closed.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 20 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ECT | – | Other: No interventions will be usedAll study subjects have consented to receive ECT. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Twelve study participants between the ages of 18-55 with will be recruited from inpatient units at McLean Hospital.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventions will be usedNo interventions will be used | Other | ECT |
Primary outcome
Gln/Glu ratio following the first ECT treatment
Time frame: Participants will undergo an MR scan within 24 hours of their 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.
1 secondary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian P Brennan, M.D. principal investigator
Mclean Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Bipolar Disorder, run by Mclean Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 29 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gln/Glu ratio following the first ECT treatment (time frame: Participants will undergo an MR scan within 24 hours of their first ECT treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2012.