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 @ 11:17 PM
Ignite Modification Date:
2025-12-24 @ 11:17 PM
NCT ID:
NCT00327756
Eligibility Criteria:
* INCLUSION CRITERIA:
* Male or female subjects, 18 to 65 years of age.
* Female subjects of childbearing potential must be using a medically accepted means of contraception.
* Each subject must understand the nature of the study and must sign an informed consent document.
* Subjects must fulfill the criteria for Bipolar disorder depressed without psychotic features including rapid cycling as defined in DSM-IV based on clinical assessment and confirmed by structured diagnostic interview SCID-P.
* Subjects must have an initial score at Visit 1 and Visit 2 of at least 16 on the MADRS
* In bipolar II disorder, subjects must have experienced, in the opinion of the investigator, at least two previous hypomanic and two major depressive episodes as defined in DSM-IV.
* Current major depressive episode at least 4 weeks in duration.
EXCLUSION CRITERIA:
* Subjects who are currently on a mood stabilizer for maintenance treatment and are benefiting from it.
* Current diagnosis of primary anxiety disorder necessitating treatment (subjects with OCD will be excluded).
* Presence of psychotic features
* Participation in a clinical trial of another investigational drug within 1 month prior to study entry (Visit 1).
* Female subjects who are either pregnant or nursing.
* Serious, unstable illnesses including hepatic, renal, gastroenterological, respiratory, cardiovascular (including ischemic heart disease), endocrinology, neurological, immunologic, or hematological disease.
* Subjects diagnosed with a mitochondrial disorder.
* Subjects taking other putative mitochondrial enhancers (e.g., vitamin E, carnitine, creatine, Vit complex B, pramipexole; see Appendix B) by the time of randomization (Visit 2).
* Subjects taking Statins
* Subjects with Diabetes Mellitus (Type I and Type II)
* Subjects with a history of clotting disorders or needing anticoagulants e.g. warfarin.
* Subjects with history of deep vein thrombosis or the following risk factors for DVTs, smoking and/or contraceptives (30 days before Visit 2).
* Subjects with uncorrected hypothyroidism or hyperthyroidism.
* Subjects with one or more seizures.
* Documented history of hypersensitivity or intolerance to CoQ10.
* DSM-IV substance abuse (except caffeine) within the past 12 months, 1 month for nicotine.
* DSM-IV lifetime substance dependence (except caffeine).
* Treatment with an injectable depot neuroleptic within less than one dosing interval prior to Visit 2.
* Treatment with a reversible MAOI, guanethidine, or guanadrel within 1 week prior to Visit 2.
* Treatment with fluoxetine within 6 weeks prior to Visit 2.
* Treatment with any other concomitant medication 1 day prior to Visit 2.
* Treatment with clozapine or ECT within 1 month prior to Visit 2.
* Judged clinically to be at serious suicidal risk.
Healthy Control Sample: Twenty-six subjects (ages 18-65) who do not meet criteria for any major medical or psychiatric disorder (using SCID -NP) will undergo imaging and mitochondrial assay part of the study and serve as control group. Control subjects will be matched to bipolar subjects for age, gender, Body Mass Index (BMI) plus or minus 2.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00327756
Study Brief:
Protocol Section:
NCT00327756