Change in Brain Bioenergetics in Bipolar Disorder in Response to Photic Stimulation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00801567
Recruitment Status : Withdrawn (Departure of essential Co-Investigator from McLean Hospital)
First Posted : December 3, 2008
Last Update Posted : March 12, 2012
Information provided by (Responsible Party):
Brian P. Brennan, MD, Mclean Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Schizophrenia Healthy Controls Device: Magnetic resonance spectroscopy (MRS) Not Applicable

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  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: A Magnetic Resonance Spectroscopy Study of Change in Brain Bioenergetics in Bipolar Disorder in Response to Photic Stimulation
Study Start Date : June 2010
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

Arm Intervention/treatment
Experimental: 1
All subjects will receive the intervention (MRS scan).
Device: Magnetic resonance spectroscopy (MRS)
90-minute magnetic resonance scan.

Primary Outcome Measures :
  1. Change in brain levels of phosphocreatine (PCr), beta-nucleoside triphosphate (B-NTP), and intracellular pH (pHi). [ Time Frame: 42 minutes ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00801567

United States, Massachusetts
McLean Hospital
Belmont, Massachusetts, United States, 02478
Sponsors and Collaborators
Mclean Hospital
Principal Investigator: Brian P Brennan, MD Mclean Hospital

Responsible Party: Brian P. Brennan, MD, Associate Director of Translational Neuroscience Research, Mclean Hospital Identifier: NCT00801567     History of Changes
Other Study ID Numbers: 2008-P-001958
First Posted: December 3, 2008    Key Record Dates
Last Update Posted: March 12, 2012
Last Verified: March 2012

Keywords provided by Brian P. Brennan, MD, Mclean Hospital:
Bipolar disorder
Healthy volunteer
Brain imaging
Photic stimulation

Additional relevant MeSH terms:
Bipolar Disorder
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Bipolar and Related Disorders