CoQ10 in Geriatric Bipolar Depression
This study is ongoing, but not recruiting participants.
Sponsor:
Mclean Hospital
Collaborator:
National Alliance for Research on Schizophrenia and Depression
Information provided by (Responsible Party):
Brent Forester, Mclean Hospital
ClinicalTrials.gov Identifier:
NCT00720369
First received: July 18, 2008
Last updated: September 13, 2011
Last verified: September 2011
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Purpose
We propose to study and compare measures of brain energy metabolism in geriatric bipolar individuals and healthy older adults. We would also like to investigate changes in brain energy metabolites and in vivo creatine kinase (CK) enzymatic activity associated with CoQ10 administration in older bipolar individuals.
| Condition | Intervention |
|---|---|
|
Bipolar Depression |
Dietary Supplement: CoEnzyme Q10 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | Oral Administration of CoQ10 and Phosphorus-31 Magnetization Transfer Magnetic Resonance Spectroscopy in Geriatric Bipolar Disorder and Healthy Older Adults |
Resource links provided by NLM:
Further study details as provided by Mclean Hospital:
Primary Outcome Measures:
- We will measure the rate constant of creatine kinase in individuals with bipolar depression before an after treatment with CoQ 10. [ Time Frame: 8 week trial ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- We will measure response to treatment of depression (Using the MADRS rating scale)in older adults with bipolar disorder after an 8 week trial of CoQ10. [ Time Frame: 8 week trial ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 16 |
| Study Start Date: | July 2008 |
| Estimated Study Completion Date: | December 2011 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
A
Open Label Study
|
Dietary Supplement: CoEnzyme Q10
CoEnzyme Q10 with dosage range from 400 mg to 1200 mg per day
|
Detailed Description:
Hypotheses
- At baseline, the forward rate constant (kfor) of CK enzymatic activity in the frontal lobe of older subjects with bipolar depression will be significantly decreased relative to that of age-matched healthy controls.
- After 8 weeks of treatment, bipolar depression subjects will demonstrate an increase in the kfor of CK after 8 weeks of CoQ 10 treatment.
- Increases in the CK forward rate constant (kfor) will correlate with improvement in subjects' mood state as assessed by the Montgomery Asberg Depression Rating Scale (MADRS).
- Baseline measures of executive functioning and information processing speed (measured by performance on the Wisconsin Card Sorting Test (WCST), Trails A and B and Stroop tests) will be impaired in subjects with geriatric bipolar depression compared with healthy controls. These measures will improve with successful treatment with CoQ10 and correlate with increases in the CK forward rate constant (kfor).
Summary:
A review of literature suggests a distinct pattern of bioenergetic changes, possibly related to mitochondrial dysfunction and abnormal CK function, in older adults and in individuals with bipolar disorder. As opposed to rudimentary measurements of static metabolite concentrations, the novel use of MT-MRS in such individuals will offer insight into the enzyme kinetics of CK, specifically examining the rate at which ATP is formed from PCr. From previous investigations it would seem that the dietary-supplement, CoQ10, is able to improve the efficiency of mitochondrial function in subjects with altered bioenergetics. We propose to measure CK activity and PCr turnover rate before and after CoQ10 treatment, with the overall aim of understanding metabolic relationships between brain bioenergetic alterations and treatment with CoQ10 in geriatric bipolar depression.
Eligibility| Ages Eligible for Study: | 55 Years to 89 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- 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 six study visits during the 8-week duration of the study
- Subjects may be taking other medications for bipolar depression including antidepressants, mood stabilizers and antipsychotic mediations prior to Co-Q10 therapy, but may not have any dosage adjustments of these medications in the week before Co-Q10 is added.
Exclusion Criteria:
- 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.
- Use of medications that are excluded in this study (barbiturates; however, the use of non-benzodiazepine sedative hypnotics (such as zolpidem (Ambien)) may be used as needed except within 12 hours of the MRI scan)
- Benzodiazepines 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.
- Any of the exclusion criteria mentioned in the MRI risks section below
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00720369
Locations
| United States, Massachusetts | |
| McLean Hospital | |
| Belmont, Massachusetts, United States, 02478 | |
Sponsors and Collaborators
Mclean Hospital
National Alliance for Research on Schizophrenia and Depression
Investigators
| Principal Investigator: | Brent P Forester, MD | Mclean Hospital |
More Information
No publications provided
| Responsible Party: | Brent Forester, Director, Mood Disorders Division, Geriatric Psychiatry Research Program, Mclean Hospital |
| ClinicalTrials.gov Identifier: | NCT00720369 History of Changes |
| Other Study ID Numbers: | 2008-P-000738/1 |
| Study First Received: | July 18, 2008 |
| Last Updated: | September 13, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Mclean Hospital:
|
Bipolar depression elderly Coenzyme Q10 Magnetic resonance spectroscopy |
Additional relevant MeSH terms:
|
Bipolar Disorder Depression Depressive Disorder Affective Disorders, Psychotic Mood Disorders Mental Disorders Behavioral Symptoms |
Coenzyme Q10 Ubiquinone Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Vitamins |
ClinicalTrials.gov processed this record on May 23, 2013