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

• Status: Completed
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mclean Hospital
• Collaborator: National Institute of Mental Health (NIMH)
• Treatments: Coenzyme Q10; Ubiquinone

Criteria

Inclusion Criteria for Bipolar Depressed Subjects:

• 55 years or older

• Meet DSM-IV diagnostic criteria for Bipolar Disorder, Current Episode Depressed

• Montgomery Asberg Depression Rating Scale (MADRS) Score of >20

• If the MADRS score is <20 but >16, a diagnosis of bipolar disorder, current episode depressed, based on the Structured Clinical Interview of DSM IV TR (SCID) and Dr. Forester's initial interview would allow the subject to be included in the study.

• Young Mania Rating Scale (YMRS) Score of < 6

• If the YMRS score is >6 subjects can still be admitted if subjects do not meet clinical criteria for mania or hypomania at the time of screening

• Able to provide informed consent

• Must speak English

• Must be able to visit McLean Hospital for the screening visit and three-four study visits during the 4-5 week duration of the study

• Subjects may be taking other medications for bipolar depression including antidepressants, mood stabilizers and antipsychotic medications prior to Co-Q10 therapy, but will be encouraged not to have any dosage adjustments of these medications in the week before Co-Q10 is added and throughout their participation in the 4-week study. Changes to concomitant medication during the time between the screening and baseline visit or during the 4-week study due to a clinical need will be allowed. All concomitant medication changes will be noted in the study documents.

Exclusion Criteria for Bipolar Depressed Subjects:

• Serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease

• History of seizure disorder,

• History or current diagnosis of the following psychiatric illnesses: any organic mental disorder (including dementia), schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorder not otherwise specified, unipolar major depressive disorder, patients with substance dependence disorders, including alcohol, active within the last 12 months.

• History of drug hypersensitivity or intolerance to Coenzyme Q10.

• Current treatment with barbiturates.

• Benzodiazepines, and non-benzodiazepine sedative hypnotics (such as zolpidem (Ambien), may be used by subjects throughout the study as long as they are not taken within 12 hours of any MRI scan.

• Subjects diagnosed with a mitochondrial disorder

• Subjects taking other putative mitochondrial enhancers (e.g., vitamin E, carnitine, creatine, Vitamin complex B, pramipexole) at the time of study entry.

• Subjects who either have metal objects in their bodies or work with metal or tools that could leave small pieces of metal in their eyes or skin will be excluded from the study as it is unsafe for them to have MRI scans.

• Women who are pregnant or are trying to become pregnant during their participation in the study.

Inclusion Criteria for Control Subjects:

• 55 years or older

• Able to provide informed consent

• Must speak English

• Women entering this study must be post-menopausal.

Exclusion Criteria for Control Subjects:

Same criteria for the Bipolar Depressed group with the exception of the "first episode of mania" which is not applicable, and patients with a lifetime history of substance dependence disorders, including alcohol, will be excluded.