Hello to all current and future volunteers who make the NIH healthy volunteer program possible. Perhaps you are currently involved in a study, participated many years ago, or are about to volunteer for the first time. Whatever the case, this newsletter will give you valuable new information. Following are a few of the many new clinical trials currently recruiting healthy volunteers.

Why not participate in a heart related clinical study at the NIH?

Endothelial Cell Dysfunction in Plexogenic Pulmonary Arteriopathy: Biomarkers, Mechanisms of Disease and Novel Therapeutic Targets
Study Number: 05-CC-0041
This study will examine and test healthy volunteers and patients with pulmonary hypertension to try to learn more about the disease and find better ways to detect, treat, and, if possible, slow progression. Pulmonary hypertension is a rare blood vessel disorder of the lungs in which the pressure in the pulmonary artery (the blood vessel that leads from the heart to the lungs) rises above normal levels and may become life-threatening. Normal volunteers and patients with pulmonary hypertension 18 years of age and older may be eligible for this study. All candidates are screened with a review of their medical records. Healthy volunteers also have a medical history, electrocardiogram, echocardiogram (heart ultrasound), and pulmonary function test, in which the subject breathes in and out of a tube that measures lung volume, mechanics and function.

Fluoxetine's Effects on Attention and Emotional Memory in Anxious and Depressed Youth
Study Number: 01-M-0192
This study will determine if Fluoxetine (Prozac®) is effective for treating anxiety or depression in children and adolescents. The study will also use functional magnetic resonance imaging (fMRI) to learn more about how the brain functions in children/adolescents taking this medication for anxiety or depression. We also offer cognitive behavioral therapy as a treatment option either in place of or in addition to Prozac.

Gender: Male & Female
Sponsoring Institute: National Institute of Mental Health (NIMH)
Type: Active Accrual of New Subjects
Eligibility Criteria: All Juvenile Subjects, age 8–17

Please see profile below for more information regarding the Principle Investigator of this study.

Neurocardiac Control in Major Depression
Study Number: 04-M-0136
This study will examine how depression may influence the way the brain regulates heart function. Some researchers believe that depression may be a risk factor for some forms of heart disease. Right-handed healthy volunteers and patients with major depressive disorder who are between 18 and 50 years of age may be eligible for this study. Female candidates must be premenopausal. Patients must currently be experiencing a major depressive episode. All candidates are screened with a medical history and physical examination, electrocardiogram, and blood and urine tests. They are interviewed about their psychiatric and medical history, current emotional state and sleep pattern, and family history of psychiatric disorders. They complete symptoms ratings scales for depresion, anxiety, and negative thinking; history of alcohol and tobacco use; level of physical activity; socioeconomic status; overall level of functioning; and, for depressed patients, their depression type. Women candidates have their menstrual phase determined by the timing of their recent menstrual cycles and may undergo testing to determine the time of their ovulation.

The Effects of Dutasteride on Mood, HPA Axis, and Serum Allopregnanolone Levels in Women with Menstrual-Related Mood Disorders and Controls
Study Number: 04-M-0139
This study will explore the effects of dutasteride on mood and the stress response across the menstrual cycle. Dutasteride blocks production of neurosteroids-hormones that help regulate the stress response systems. These systems may be disturbed in women with menstrually related mood disorders (MRMD). The effect of the drug will be compared in women with and without MRMD to determine how neurosteroids regulate mood and the stress response across the menstrual cycle. Dutasteride is approved by the Food and Drug Administration to treat benign prostatic hyperplasia (excess growth of the prostate gland) in men. Menstruating women 30 to 45 years of age with and without MRMD may be eligible for this study. Candidates are screened with a medical and psychiatric history, physical examination, screening for symptoms of depression, and routine blood and urine tests. Participants are required to use barrier contraception (condoms or diaphragm) during the 3-month study and 6-month follow-up.

More Clinical Trials

• The Functional Anatomy of Personality Trait Knowledge
• The Effects of Hydrocortisone, Melatonin, and Placebo on Symptoms of Jet Lag
• Neural Correlates of Observation of Tactile timulation in Healthy Subjects
• fMRI Study on Mechanism of Rhythm Perception and Generation

Search for more examples of clincal trials for healthy volunteers at http://clinicalstudies.info.nih.gov/. Please type the word “Healthy” for a full listing of Healthy Volunteer opportunities.

	Dr. Daniel Pine is Chief of the section on Development and Affective Neuroscience and Chief of Child and Adolescent Research in the Mood and Anxiety Disorders Program of the National Institute of Mental Health Intramural Research Program. Q: What is the primary focus? A: “Anxiety and Depression” Q: How long have you been working with healthy volunteers in your studies? A: For the past four years, we’ve been recruiting many healthy children and adolescents to participate in our studies. Q: What other doctors do you work with? A: I work with a team of about 10–20 people including Doctors, Psychologists, Nurses, Neurologists, and many others. Q: Is your focus primarily adult or pediatric? A: We only work with kids and adolescents. Q: How many healthy volunteers do you usually work with every year? A: About one hundred. Q: Why are healthy volunteers so important for research medicine? A: Because in order to figure out the basic brain mechanisms, we need to study “normal volunteers.” There is so little knowledge about our brain’s emotional and physical development that we depend on volunteers to provide a baseline for our research Q: What is your motto regarding research? A: Two parts – First, I believe that everyone should feel a tremendous sense of compassion for those people we are studying and a tremendous commitment to making their lives better. Secondly, I place a high emphasis on people being interested in what they do. My colleagues and I love being doctors and hope that both our patients and our healthy volunteers learn something and enjoy partaking in an interesting and worthwhile experience.