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

NCT01390389 | Completed Results DMC

• 2 other identifiers: 2011-P-000980K23MH077287
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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

Bipolar Depression

Keywords

Geriatric bipolar depression; MR Spectroscopy; Coenzyme Q10; Mitochondrial Dysfunction

Outcome Measures

Primary Outcomes (1)

• Mean Concentrations of Cerebral Energetic Metabolites in Geriatric BPD and Older Controls at Baseline

  Tissue-specific (gray or white matter) concentrations of of Phosphocreatine (PCr), Beta-Nucleoside Triphosphate (bNTP), and Inorganic Phosphate (Pi) in geriatric BPD compared with healthy controls at baseline. Concentrations were measured using CSI P MRS scan at 4T. The analysis of signal intensity is done through integration of the area under the curve and is expressed in arbitrary units.

  Baseline

Secondary Outcomes (1)

• To Determine Effects of CoQ 10 on Bioenergetics (PCr and Beta NTP) in Older Adults With Bipolar Depression.

  4-week trial

Study Arms (2)

CoQ10

EXPERIMENTAL

Subjects who meet DSM-IV diagnostic criteria for Bipolar Disorder, Current Episode Depressed are assigned to this arm and administered the Coenzyme Q10 intervention. 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.

Drug: Coenzyme Q10

Control

NO INTERVENTION

Subjects without a known psychiatric disorder and/or unstable medical illness are assigned to the control group. The control subjects are not given CoQ10.

Interventions

Coenzyme Q10 DRUG

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.

Also known as: ubiquinone

CoQ10

Eligibility Criteria

• Age: 55 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• years or older
• Able to provide informed consent
• Must speak English
• Women entering this study must be post-menopausal.
• 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.

Sponsors & Collaborators

• Mclean Hospital: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

MeSH Terms

Conditions

Bipolar Disorder; Mitochondrial Diseases

Interventions

coenzyme Q10; Ubiquinone

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Benzoquinones; Quinones; Organic Chemicals; Coenzymes; Enzymes and Coenzymes

Results Point of Contact

• Title: Cara McCabe
• Organization: McLean Hospital

cfmccabe@partners.org

617-855-2410

Study Officials

• Brent P Forester, M.D.

  Mclean Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: July 7, 2011
• First Posted: July 11, 2011
• Study Start: July 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: December 7, 2017
• Results First Posted: November 25, 2013

Record last verified: 2017-11

Locations

US (1)