Change in Brain Bioenergetics in Bipolar Disorder in Response to Photic Stimulation - Full Text View

Sponsored by:	Mclean Hospital
Information provided by:	Mclean Hospital
ClinicalTrials.gov Identifier:	NCT00801567

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)

MedlinePlus related topics: Bipolar Disorder Nuclear Scans Schizophrenia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Open Label, Active Control, Single Group Assignment
Official Title:	A Magnetic Resonance Spectroscopy Study of Change in Brain Bioenergetics in Bipolar Disorder in Response to Photic Stimulation

Further study details as provided by 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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	December 2008
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00801567

Contacts

Contact: Caitlin Coit, BA	(617) 855-2984	ccoit@mclean.harvard.edu
Contact: Jacqueline Roberts, BA	(617) 855-2434	jroberts@mclean.harvard.edu

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:	McLean Hospital ( Brian P. Brennan, M.D. )
Study ID Numbers:	2008-P-001958
Study First Received:	December 2, 2008
Last Updated:	December 4, 2008
ClinicalTrials.gov Identifier:	NCT00801567
Health Authority:	United States: Institutional Review Board

Keywords provided by Mclean Hospital:

Bipolar disorder
Schizophrenia
Healthy volunteer
Brain imaging
Photic stimulation

Study placed in the following topic categories:

Schizophrenia
Affective Disorders, Psychotic
Mental Disorders
Bipolar Disorder

Mood Disorders
Psychotic Disorders
Healthy
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Pathologic Processes
Disease

ClinicalTrials.gov processed this record on January 16, 2009