Clinical & Research Activities
- Relapse Prevention of Bipolar Type II Disorder
- Treatment of Bipolar Type II Major Depression
- Prevention of Relapse & Recurrence of Bipolar Type I Depression
- 123I ADAM SPECT Brain Imaging as a Bio-Marker of Major Depression
- 99mTcTRODAT-1 SPECT Brain Imaging as a Bio-marker of Major Depression
- Chamomile Therapy for Generalized Anxiety Disorder
- Black Cohosh Therapy for Menopause-Related Anxiety
Relapse Prevention of Bipolar Type II Disorder
Bipolar type II (BP II) disorder ("mood swings") affects nearly 2.5% of the adult population and can result in an annualized healthcare cost of $40 billion. BP II disorder differs from BP I ("manic depressive") disorder in that it lacks the manic episodes and is characterized by a preponderance of depressive episodes. It has a high rate of association with substance abuse, school and work problems, and marital problems. It also is associated with a high mortality rate from suicide. The treatment of BP II disorder remains a challenge for clinicians. Current practice guidelines recommend treating BP II depression with mood stabilizer therapy, rather than antidepressant drug therapy. To date, there have been few controlled clinical studies to test which of these treatments is most effective.
This study seeks to answer the following questions:
- Is fluoxetine (Prozac) therapy an effective initial treatment for patients with BP II depression?
- Is fluoxetine therapy an effective treatment for prevention of depressive relapse and recurrence of BP II depression over a one-year period?
- Is fluoxetine therapy associated with a low incidence of mood swings (“hypomanic switch episodes”) during initial and long-term relapse prevention therapy of BP-II disorder?
Treatment of Bipolar Type II Major Depression
Bipolar type II (BP II) disorder ("mood swings") affects 2.5% of the adult population and results in an annualized healthcare cost of $40 billion. BP II disorder differs from BP I (manic depressive) disorder in that it lacks manic episodes and is characterized by a preponderance of depressive episodes. It can be associated with a high morbidity and mortality rate. The treatment of BP II disorder remains a challenge for clinicians. Current practice guidelines recommend initial treatment of BP II depression with mood stabilizer therapy and to avoid antidepressant drug therapy. To date, there are few controlled clinical studies to establish the best initial and long-term therapy of BP II disorder.
This study seeks to answer the following questions:
- What is the relative effectiveness of initial antidepressant drug therapy versus initial mood stabilizer therapy of BP II depression?
- What is the relative tolerability and hypomanic switch rate of initial antidepressant drug therapy versus initial mood stabilizer therapy?
- What is the relative effectiveness of continuation antidepressant drug therapy versus continuation mood stabilizer therapy in BP II patients who have recovered from their depression?
Prevention of Relapse & Recurrence of Bipolar Type I Depression
Bipolar type I (BP I) ("manic depressive") disorder is now recognized as a major mental health problem. Recurrent BP I depression is a disorder with no satisfactory therapy, and its treatment remains a challenge to clinicians. To date, initial and long-term therapy of BP I depression has been based on un-validated practice guidelines. These guidelines recommend avoiding antidepressant drugs and using mood stabilizer therapy for initial and long-term treatment of BP I depression. However, there is no empirical evidence to suggest that mood stabilizer monotherapy is superior to a combination of mood stabilizer plus antidepressant drug therapy in the initial and long-term treatment of BP I disorder. Nor is there evidence to suggest that long-term use of antidepressant drug therapy of BP I disorder results in more manic switch episodes (versus mood stabilizer monotherapy).
This study seeks to answer the following questions:
- Does continuation therapy with combined mood stabilizer plus an antidepressant result in fewer depressive relapses and recurrences versus mood stabilizer monotherapy?
- What is the relative safety, tolerability, and frequency of manic, hypomanic, and mixed mood state episodes during long-term treatment with combined mood stabilizer plus antidepressant drug versus mood stabilizer monotherapy?
123I ADAM SPECT Brain Imaging as a Bio-Marker of Major Depression
Recent brain imaging studies using a single photon emission computed tomography (SPECT) camera or a positron emission tomography (PET) camera suggest that some depressed patients may have altered levels of a chemical messenger called serotonin in certain areas of the brain, and that this disturbance may 'normalize' with clinical improvement.
This study seeks to answer the following questions:
- Do lower serotonin levels in the brain represent a bio-marker (or "laboratory test") for depression when compared to brain serotonin levels in individuals who are not depressed?
- Do lower serotonin levels in the brain represent a bio-marker (or "laboratory test") of depression that 'normalizes' when depressed patients respond to psychotherapy (compared to patients who do not respond to psychotherapy)?
- Do brain serotonin levels remain stable over time in non-depressed individuals?
99mTcTRODAT-1 SPECT Brain Imaging as a Bio-marker of Major Depression
Recent brain imaging studies using SPECT or PET technology suggest that some depressed patients may have altered levels of a chemical messenger called dopamine in certain areas of the brain, and that this disturbance may 'normalize' with clinical improvement.
This study seeks to answer the following questions:
- Do dopamine levels in the brain represent a bio-marker (or "laboratory test") for depression when compared to brain dopamine levels in individuals who are not depressed?
- Do altered dopamine levels in the brain represent a bio-marker (or "laboratory test") of depression that 'normalizes' when depressed patients respond to antidepressant medication or psychotherapy (compared to patients who do not respond as well to these treatments)?
- Do brain dopamine levels remain stable over time in non-depressed individuals?
Chamomile Therapy for Generalized Anxiety Disorder
As part of our expanding program to study the effectiveness and tolerability of complementary and alternative medicine (CAM) remedies for anxiety and mood disorders, we selected several herbal remedies. Chamomile is one of the most widely used herbal remedies worldwide for many ailments. In this study, we propose to investigate the anti-anxiety activity of chamomile. Among the many uses of chamomile, its use as a calming remedy for anxiety symptoms has been universally observed. Despite its widespread use and acceptance, there have been no clinical studies evaluating the safety and anti-anxiety effectiveness of chamomile in humans.
This study seeks to answer the following questions:
- Is Chamomile an effective alternative treatment for Generalized Anxiety Disorder (GAD)?
- Is Chamomile a safe and well tolerated alternative treatment for GAD?
Black Cohosh Therapy for Menopause-Related Anxiety
As part of our expanding program to study the effectiveness and tolerability of complementary and alternative medicine (CAM) remedies for anxiety and mood disorders, we selected several herbal remedies. Although most treatment studies of menopausal women have focused on vasomotor symptoms ("hot flushed"), nearly 4 out of 10 menopausal women do not have hot flushes, and up to 90% complain of psychological symptoms (e.g., anxiety, nervousness, irritability, fatigue, mood lability, depression, and low libido). Given recent concerns about the safety of hormone replacement therapy of menopause, many women are seeking alternative treatments for the symptoms of menopause. Black cohosh is a Native American herbal remedy that has received much attention for the treatment of menopausal symptoms. While black cohosh appears to be effective for reducing hot flushes, there have been no studies of the anti-anxiety benefit of black cohosh for the psychological symptoms of menopause.
This study seeks to answer the following questions:
- Is black cohosh an effective alternative treatment of menopause-related anxiety?
- Is black cohosh a safe and well tolerated alternative treatment of menopause-related anxiety?
- Does black cohosh confer an enhanced quality of life (including libido and sexual performance) in women with menopause-related anxiety?
For More Information 
To learn more about our current treatment programs or ask specific questions about the unit please call or email us.
