N/A
N=19
CoQ10 in Geriatric Bipolar Depression
Bipolar Depression
Bottom Line
View on ClinicalTrials.gov: NCT00720369 ↗Enrolled (actual)
19
Serious AEs
5.3%
Results posted
Jan 2014
Primary outcome: Primary: 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). — 0.02; 0.03 per second
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CoEnzyme Q10 (Drug)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- All
- Sponsor
- Mclean Hospital
- Primary completion
- Mar 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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). |
0.02; 0.03 | — |
| SECONDARY 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. |
21.4; 18.4 | — |
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.
Eligibility 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 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 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
Data sourced from ClinicalTrials.gov (NCT00720369). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.