Bipolar DepressionCoQ10NCT00720369
CoQ10 in Geriatric Bipolar Depression
A study testing CoEnzyme Q10 in people with Bipolar Depression, run by Mclean Hospital at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 55 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Bipolar Depression
- What is being tested?
- CoEnzyme Q10
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Mar 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oral Administration of CoQ10 and Phosphorus-31 Magnetization Transfer Magnetic Resonance Spectroscopy in Geriatric Bipolar Disorder and Healthy Older Adults
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.
Read the 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.
- Conditions
- Bipolar Depression
- Being tested
- CoEnzyme Q10
- Keywords
- Bipolar depression, elderly, Coenzyme Q10, Magnetic resonance spectroscopy
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoEnzyme Q10Drug
CoEnzyme Q10 with dosage range from 400 mg to 1200 mg per day
| Study group | Role | What they receive |
|---|---|---|
| CoEnzyme Q10 | Experimental | Open Label Study Receives: Drug: CoEnzyme Q10 |
| Healthy Controls | No intervention | Healthy controls completed all study procedures completed by the CoQ10 group but did not receive any study medication. |
What is being measured
The primary outcome is the main question the study is designed to answer.
We Measured the Change in Rate Constant of Creatine Kinase in Individuals With Bipolar Depression Treated With CoQ 10 as Compared With Age and Gender Matched Controls. These Rate Constants Were Calculated Using Magnetic Resonance Imaging (MRI).
The rate constant for creatine kinase is a measurement of the reaction rate ADP+PCr <---> ATP + Cr, which is catalyzed by the enzyme creatine kinase. The rate constant shows the direction and magnitude of the reaction at equilibrium. A higher rate constant indicates a higher rate constant of the CK enzyme, meaning, more efficient/rapid conversion of PCr to ATP through the creatine kinase enzymatic reaction in tissues with high and fluctuating energy demands such as brain and muscle tissue. As the value is a reaction rate, there are no associated units.
Measured: 8 week trial
Secondary outcomes (1)
We Measured Response to Treatment of Depression (Using the Montgomery Asberg Depression Rating Scale)in Older Adults With Bipolar Disorder After an 8 Week Trial of CoQ10.
The Montgomery Asberg Depression Rating Scale (MADRS) is a 10 question questionnaire which assesses symptom severity of depression. The score is on a 0-60 scale with higher numbers indicating more severe depressive symptoms. The score is represented as a number of points.
Clinical improvement following treatment with CoQ10 supplement was only tested in the Bipolar subject cohort, not in healthy controls, therefore outcome data only apply to the bipolar group.
Measured: 8 week trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bipolar DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mclean Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Alliance for Research on Schizophrenia and Depression
- Responsible party
- Principal investigator, Brent Forester, Mclean Hospital
- Investigators
- Brent P Forester, MD, Principal investigator, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00720369
- Sponsor's protocol ID
- 2008-P-000738/1
- Acronym
- CoQ10
- Status last verified
- Nov 2013
- First submitted
- 18 Jul 2008
- Last updated
- 13 Jan 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Administration of CoQ10 and Phosphorus-31 Magnetization Transfer Magnetic Resonance Spectroscopy in Geriatric Bipolar Disorder and Healthy Older Adults
- ClinicalTrials.gov ID
- NCT00720369
- Acronym / sponsor ID
- CoQ10 / 2008-P-000738/1
- Conditions
- Bipolar Depression
- Keywords
- Bipolar depression, elderly, Coenzyme Q10, Magnetic resonance spectroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Collaborators
- National Alliance for Research on Schizophrenia and Depression
- Study start
- Jul 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 22 Jul 2008 (estimated)
- Results
- Posted 13 Jan 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CoEnzyme Q10 | Experimental | Drug: CoEnzyme Q10Open Label Study |
| Healthy Controls | No intervention | –Healthy controls completed all study procedures completed by the CoQ10 group but did not receive any study medication. |
Who may qualify
- Ages
- 55 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CoEnzyme Q10CoEnzyme Q10 with dosage range from 400 mg to 1200 mg per day | Drug | CoEnzyme Q10 |
Primary outcome
We Measured the Change in Rate Constant of Creatine Kinase in Individuals With Bipolar Depression Treated With CoQ 10 as Compared With Age and Gender Matched Controls. These Rate Constants Were Calculated Using Magnetic Resonance Imaging (MRI).
Time frame: 8 week trial
The rate constant for creatine kinase is a measurement of the reaction rate ADP+PCr <---> ATP + Cr, which is catalyzed by the enzyme creatine kinase. The rate constant shows the direction and magnitude of the reaction at equilibrium. A higher rate constant indicates a higher rate constant of the CK enzyme, meaning, more efficient/rapid conversion of PCr to ATP through the creatine kinase enzymatic reaction in tissues with high and fluctuating energy demands such as brain and muscle tissue. As the value is a reaction rate, there are no associated units.
1 secondary outcome
We Measured Response to Treatment of Depression (Using the Montgomery Asberg Depression Rating Scale)in Older Adults With Bipolar Disorder After an 8 Week Trial of CoQ10.
Time frame: 8 week trial
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brent P Forester, MD principal investigator
Mclean Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CoEnzyme Q10 in people with Bipolar Depression, run by Mclean Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
We Measured the Change in Rate Constant of Creatine Kinase in Individuals With Bipolar Depression Treated With CoQ 10 as Compared With Age and Gender Matched Controls. These Rate Constants Were Calculated Using Magnetic Resonance Imaging (MRI). (time frame: 8 week trial). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2014; AzTrials last refreshed its copy on 30 Oct 2026.