Status:
WITHDRAWN
Mitochondrial Dysfunction in the Pathophysiology and Treatment of Bipolar Disorder
Lead Sponsor:
National Institute of Mental Health (NIMH)
Conditions:
Bipolar Affective Disorder
Depression
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This study will examine whether mitochondrial function is impaired in patients with bipolar disorder. Mitrochondria are small organelles inside the cell that are responsible for energy production. Rec...
Detailed Description
Bipolar affective disorder is a common, severe, chronic and often life-threatening illness. The depressive phase contributes to the majority of morbidity and mortality in this illness. Impairments in ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00327756
Start Date
May 1 2006
Last Update
November 23 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892