Mitochondrial Dysfunction in the Pathophysiology and Treatment of Bipolar Disorder
Status:
Withdrawn
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
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. Recent studies in animals and humans suggest that abnormalities of mitrochondria
may be involved in bipolar depression. The study will also examine whether the food
supplement Coenzyme Q10 (CoQ10) improves mitochondrial function and symptoms such as
depressed mood, low energy, anxiety or slowness in thinking and movements in bipolar
patients. CoQ10 has been used to increase cell energy production and as an antioxidant. It
has had some benefit in patients with Parkinson's disease and migraine and in prolonging
survival in patients with cancer and heart failure.
Patients 18-65 years of age with bipolar disorder who are currently in a depressive episode
of at least 4 weeks duration may be eligible for this study. The study has four phases, as
follows:
Phase I: Medication Withdrawal
Patients taper off all psychotropic medications, usually over 1 to 2 weeks.
Phase II: Baseline Evaluation
After being off all medication for about 2 weeks, patients undergo the following procedures:
- Magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS). The two
procedures are performed in an MRI scanner. Both tests use a strong magnetic field and
radio waves to obtain images that provide information on brain anatomy and chemistry.
- Blood tests to assess mitochondrial function isolated from blood cells.
- Skin biopsy for tests of mitochondria. A small sample of skin tissue 5 x 5 millimeters
is surgically removed.
Phase III: Administration of CoQ10 or Placebo
Participants are randomly assigned to take either CoQ10 or placebo (an inactive look-alike
substance) twice a day by mouth. While taking the study medication, patients have the
following procedures periodically:
- Rating scales for anxiety and depression and adverse events.
- Check of vital signs.
- Blood and urine sample collections.
Phase IV: Study Completion
At the end of the 8 weeks of treatment, patients have a physical examination and
electrocardiogram, and the procedures in phase II are repeated. Participants may then receive
short-term treatment (up to 12 weeks) with medications for bipolar depression, followed by
referred to a community physician for long-term treatment.
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