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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Brent Forester, Mclean Hospital
ClinicalTrials.gov Identifier:
NCT01390389
First received: July 7, 2011
Last updated: October 30, 2013
Last verified: August 2013
  Purpose

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.

Condition Intervention
Bipolar Depression
Drug: Coenzyme Q10

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Exploring the Effects of Coenzyme Q10 on Bioenergetics Metabolism in Geriatric Bipolar Depression: A 31 Phosphorus MR Spectroscopy Study

Resource links provided by NLM:


Further study details as provided by Mclean Hospital:

Primary Outcome Measures:
  • Mean Concentrations of Cerebral Energetic Metabolites in Geriatric BPD and Older Controls at Baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • To Determine Effects of CoQ 10 on Bioenergetics (PCr and Beta NTP) in Older Adults With Bipolar Depression. [ Time Frame: 4-week trial ] [ Designated as safety issue: No ]
    Changes in PCr and beta NTP will be demonstrated in Geri BD group challenged with CoQ10.


Enrollment: 19
Study Start Date: July 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CoQ10

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

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.

Other Name: ubiquinone
No Intervention: Control
Subjects without a known psychiatric disorder and/or unstable medical illness are assigned to the control group. The control subjects are not given CoQ10.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   55 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01390389

Locations
United States, Massachusetts
McLean Hospital
Belmont, Massachusetts, United States, 02478
Sponsors and Collaborators
Mclean Hospital
Investigators
Principal Investigator: Brent P Forester, M.D. Mclean Hospital
  More Information

No publications provided

Responsible Party: Brent Forester, PI, Mclean Hospital
ClinicalTrials.gov Identifier: NCT01390389     History of Changes
Other Study ID Numbers: 2011-P-000980, K23MH077287
Study First Received: July 7, 2011
Results First Received: August 26, 2013
Last Updated: October 30, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Mclean Hospital:
Geriatric bipolar depression
MR Spectroscopy
Coenzyme Q10
Mitochondrial Dysfunction

Additional relevant MeSH terms:
Bipolar Disorder
Depression
Depressive Disorder
Affective Disorders, Psychotic
Behavioral Symptoms
Mental Disorders
Mood Disorders
Coenzyme Q10
Ubiquinone
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Vitamins

ClinicalTrials.gov processed this record on October 29, 2014