Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2025-12-24 @ 11:10 PM
NCT ID:
NCT00720369
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 \<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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
55 Years
Maximum Age:
89 Years
Study:
NCT00720369
Study Brief:
Protocol Section:
NCT00720369