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

This study has been withdrawn prior to enrollment.
(Departure of essential Co-Investigator from McLean Hospital)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00801567
First Posted: December 3, 2008
Last Update Posted: March 12, 2012
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.
Information provided by (Responsible Party):
Brian P. Brennan, MD, Mclean Hospital
  Purpose
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 Intervention
Bipolar Disorder Schizophrenia Healthy Controls Device: Magnetic resonance spectroscopy (MRS)

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Brian P. Brennan, MD, Mclean Hospital:

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

Enrollment: 0
Study Start Date: June 2010
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
All subjects will receive the intervention (MRS scan).
Device: Magnetic resonance spectroscopy (MRS)
90-minute magnetic resonance scan.

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.
  Eligibility

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
Criteria

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00801567


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

Responsible Party: Brian P. Brennan, MD, Associate Director of Translational Neuroscience Research, Mclean Hospital
ClinicalTrials.gov Identifier: NCT00801567     History of Changes
Other Study ID Numbers: 2008-P-001958
First Submitted: December 2, 2008
First Posted: December 3, 2008
Last Update Posted: March 12, 2012
Last Verified: March 2012

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

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