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

Not Applicable

Withdrawn

• Conditions: Bipolar Disorder; Schizophrenia; Healthy Controls
• Interventions: Device: Magnetic resonance spectroscopy (MRS)

• Registration Number: NCT00801567
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2008-12-02
• Study First Submitted QC: 2008-12-02
• Study First Posted: 2008-12-03
• Study Start: 2010-06
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-09
• Last Update Posted: 2012-03-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Magnetic resonance spectroscopy (MRS)	All subjects will receive the intervention (MRS scan).

Primary Outcome Measures

Name	Time	Method
Change in brain levels of phosphocreatine (PCr), beta-nucleoside triphosphate (B-NTP), and intracellular pH (pHi).	42 minutes

Trial Locations

Locations (1)

McLean Hospital; 🇺🇸 Belmont, Massachusetts, United States