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Exploring the Effects of Coenzyme Q10 on Bioenergetics Metabolism in Geriatric Bipolar Depression

NCT01390389 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2017-12-07

Study results available
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Summary

The investigators propose to study and compare measures of brain energy metabolism in geriatric bipolar individuals and healthy older adults. The investigators would also like to investigate changes in brain energy metabolites associated with CoQ10 administration in older bipolar individuals. Finally, resting state functional Magnetic Resonance Imaging (fMRI) will be conducted in order to explore frontal and limbic circuitry in geriatric bipolar disorder.

* Primary Hypothesis: Baseline beta NTP and NAA will be lower, and PCr and lactate higher in Geri BPD compared with older healthy controls
* Secondary Hypothesis: Changes in PCr and beta NTP will be demonstrated in Geri BD group challenged with CoQ 10.

Conditions

Interventions

DRUG

Coenzyme Q10

Single pill consists of 400 mg and is delivered PO. CoQ10 dosing guidelines: * Visit 1 (baseline) start at 400mg once a day for two weeks * Visit 2 (within 7 days of baseline visit) increase to 800 mg once a day for two weeks The dosage of CoQ10 can be titrated in a more gradual manner depending on clinical response and tolerability of the medication, but cannot be titrated any more rapidly than the schedule above.

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • Mclean Hospital

    lead OTHER

Principal Investigators

  • Brent P Forester, M.D. · Mclean Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2012-07-31
Completion
2012-07-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01390389 on ClinicalTrials.gov