NCT00801567

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2010

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 2, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 3, 2008

Completed
1.5 years until next milestone

Study Start

First participant enrolled

June 1, 2010

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

March 12, 2012

Status Verified

March 1, 2012

Enrollment Period

Same day

First QC Date

December 2, 2008

Last Update Submit

March 9, 2012

Conditions

Bipolar DisorderSchizophreniaHealthy Controls

Keywords

Bipolar disorderSchizophreniaHealthy volunteerBrain imagingPhotic stimulation

Outcome Measures

Primary Outcomes (1)

  • Change in brain levels of phosphocreatine (PCr), beta-nucleoside triphosphate (B-NTP), and intracellular pH (pHi).

    42 minutes

Study Arms (1)

1

EXPERIMENTAL

All subjects will receive the intervention (MRS scan).

Device: Magnetic resonance spectroscopy (MRS)

Interventions

Magnetic resonance spectroscopy (MRS)DEVICE

90-minute magnetic resonance scan.

1

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male of female
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

MeSH Terms

Conditions

Bipolar DisorderSchizophrenia

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental DisordersSchizophrenia Spectrum and Other Psychotic Disorders

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Brian P Brennan, MD

    Mclean Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Director of Translational Neuroscience Research

Study Record Dates

First Submitted

December 2, 2008

First Posted

December 3, 2008

Study Start

June 1, 2010

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

March 12, 2012

Record last verified: 2012-03

Locations

US(1)