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

NCT ID: NCT00801567

Last Updated: 2012-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2010-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Bipolar Disorder Schizophrenia Healthy Controls

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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1

All subjects will receive the intervention (MRS scan).

Group Type EXPERIMENTAL

Magnetic resonance spectroscopy (MRS)

Intervention Type DEVICE

90-minute magnetic resonance scan.

Interventions

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Magnetic resonance spectroscopy (MRS)

90-minute magnetic resonance scan.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mclean Hospital

OTHER

Sponsor Role lead

Responsible Party

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Brian P. Brennan, MD

Associate Director of Translational Neuroscience Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Brian P Brennan, MD

Role: PRINCIPAL_INVESTIGATOR

Mclean Hospital

Locations

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McLean Hospital

Belmont, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2008-P-001958

Identifier Type: -

Identifier Source: org_study_id

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