- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00801567
Change in Brain Bioenergetics in Bipolar Disorder in Response to Photic Stimulation
March 9, 2012 updated by: Brian P. Brennan, MD, Mclean Hospital
A Magnetic Resonance Spectroscopy Study of Change in Brain Bioenergetics in Bipolar Disorder in Response to Photic Stimulation
This study aims to gather additional information to support the theory that bipolar disorder is due to cellular (mitochondrial) dysfunction.
To test this theory adults with bipolar disorder who are not currently symptomatic will receive a one-time brain scan (magnetic resonance spectroscopy [MRS] scan) with light stimulation.
To test whether any MRS findings are specific to bipolar disorder, healthy controls and adults with schizophrenia will also be included in this study.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Detailed Description
This study will include males and females between the ages of 18 and 55 years.
Participants will include adults with stable bipolar disorder or schizophrenia as well as healthy controls.
The study involves a one-time visit that includes a clinical evaluation, laboratory tests, and a magnetic resonance scan that will last approximately 90 minutes.
The procedures can also be separated into two study visits, if necessary.
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Belmont, Massachusetts, United States, 02478
- McLean Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male of female
- 18-55 years
- Bipolar, currently euthymic OR schizophrenia, stable, OR healthy control with no history of psychiatric illness
- On stable medication with no changes in the two weeks prior to enrollment
Exclusion Criteria:
- History of substance abuse or dependence within 3 months of enrollment
- Positive urine drug screen
- Significant medical or neurological illness
- Pregnancy
- Any contraindication to magnetic resonance scanning, including claustrophobia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
All subjects will receive the intervention (MRS scan).
|
90-minute magnetic resonance scan.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in brain levels of phosphocreatine (PCr), beta-nucleoside triphosphate (B-NTP), and intracellular pH (pHi).
Time Frame: 42 minutes
|
42 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Brian P Brennan, MD, McLean Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2010
Primary Completion (Actual)
June 1, 2010
Study Completion (Actual)
June 1, 2010
Study Registration Dates
First Submitted
December 2, 2008
First Submitted That Met QC Criteria
December 2, 2008
First Posted (Estimate)
December 3, 2008
Study Record Updates
Last Update Posted (Estimate)
March 12, 2012
Last Update Submitted That Met QC Criteria
March 9, 2012
Last Verified
March 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2008-P-001958
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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