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

Schizophrenia Clinical Trial

Official title:

A Magnetic Resonance Spectroscopy Study of Change in Brain Bioenergetics in Bipolar Disorder in Response to Photic Stimulation

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00801567
• Other study ID #: 2008-P-001958
• Status: Withdrawn
• Phase: N/A
• First received: December 2, 2008
• Last updated: March 9, 2012
• Start date: June 2010
• Est. completion date: June 2010

Study information

• Verified date: March 2012
• Source: Mclean Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Bipolar Disorder
• Healthy Controls
• Schizophrenia

Intervention

Device:
• Magnetic resonance spectroscopy (MRS)
90-minute magnetic resonance scan.

Locations

Country	Name	City	State
United States	McLean Hospital	Belmont	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Mclean Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in brain levels of phosphocreatine (PCr), beta-nucleoside triphosphate (B-NTP), and intracellular pH (pHi).		42 minutes	No