Major pharmaceutical companies constantly develop new medications, which must be proven safe and effective for human use before doctors are permitted to write prescriptions for them. Through clinical trials, also known as research studies, researchers can evaluate new investigational drugs. Such study drugs offer a no-cost alternative and are accompanied by free medical examinations and psychiatric evaluations, as part of clinical trials. The FCS staff is well experienced in conducting clinical trials and receives continuous training and certifications on FDA regulations, Good Clinical Practices and patient treatment assessments.
Dr. Fieve and his research team have participated, over the last 20 years, in trials of most of the new antidepressants that are now on the market, and this research for additional medications is ongoing. FCS is conveniently located at 952 Fifth Avenue (between 76 th and 77 th Street), Suite 7B (near the buses and the Lexington Avenue #6 subway train). FCS services patients in all five boroughs of New York City, as well as greater New York, Long Island, New Jersey and Connecticut. What is A Clinical Trial? A clinical trial is carefully designed to test the effects of a medication, medical treatment, or device on a group of volunteers. Clinical studies are an important step in making new medications available. They measure the drug’s ability to treat a condition, its safety and its possible side effects. As a result of clinical trials, thousands of safe and effective treatments are available for thousands of medical conditions, enabling people to live longer and with improved quality of life. What are the benefits and risks of participating in a clinical trial? Clinical trials may help eligible participants to:
Current enrolling studies: (as of Spring 2005) If you or some you know is suffering from or have symptoms of the any of the following, they may be eligible to participate in a clinical trial:
No health insurance is required. Generalized Anxiety Disorder: Generalized Anxiety Disorder (GAD) is a brain disorder characterized by persistent and excessive worry and tension about a number of events and activities nearly every day for at least six months. It affects twice as many women as men and can occur at any age, but the risk is highest between childhood and middle-age. Most Americans have some form of worry or anxiety, but for the four million Americans with GAD, this worry is excessive and persistent. Individuals with GAD worry excessively about everyday events and activities. The worry and tension is out of proportion to the outcomes of these events and activities; GAD sufferers often expect the worst outcomes. They typically spend more days worrying than not, and this worry persists for at least six months. Their anxiety may manifest physical symptoms as well. Having GAD can interfere with work or home life. Common symptoms of GAD may typically include:
Overview of Study: Because not all treatments work the same for all people with GAD, research is needed to identify and evaluate possible treatment options. Fieve Clinical Services is participating in a nationwide clinical research study for generalized anxiety disorder (GAD). This clinical research study is evaluating the safety and effectiveness of an investigational medication for GAD. Adults (ages 18-64) who have been diagnosed with, or experiencing symptoms of, GAD may be eligible to participate. Participation in this research study involves nine visits to Fieve Clinical Services over a period of 13-16 weeks. Volunteers who qualify and participate will receive study- related medical care including health assessments, lab tests, and study medication at no cost. If you are interested in this study:
Bipolar Disorder (Manic-Depression) Bipolar disorder typically begins in adolescence or early adulthood and continues throughout life. It is often not recognized as an illness and people who have it may suffer needlessly for years. Bipolar disorder can be extremely distressing and disruptive for those who have this disease, their spouses, family members, friends and employers. Although there is no known cure, bipolar disorder is treatable, and recovery is possible. Individuals with bipolar disorder have successful relationships and meaningful jobs. The combination of medications and psychotherapy helps the vast majority of people return to productive, fulfilling lives. What are the symptoms of bipolar disorder? Bipolar disorder causes dramatic mood swings—from overly "high" and/or irritable to sad and hopeless, and then back again, often with periods of normal mood in between. Severe changes in energy and behavior go along with these changes in mood. The periods of highs and lows are called episodes of mania and depression. Signs and symptoms of mania (or a manic episode) include:
A manic episode is diagnosed if elevated mood occurs with 3 or more of the other symptoms most of the day, nearly every day, for 1 week or longer. If the mood is irritable, 4 additional symptoms must be present. Signs and symptoms of depression (or a depressive episode) include:
A depressive episode is diagnosed if 5 or more of these symptoms last most of the day, nearly every day, for a period of 2 weeks or longer. A mild to moderate level of mania is called hypomania. Hypomania may feel good to the person who experiences it and may even be associated with good functioning and enhanced productivity. Thus even when family and friends learn to recognize the mood swings as possible bipolar disorder, the person may deny that anything is wrong. Without proper treatment, however, hypomania can become severe mania in some people or can switch into depression. It may be helpful to think of the various mood states in bipolar disorder as a spectrum or continuous range. At one end is severe depression, above which is moderate depression and then mild low mood, which many people call "the blues" when it is short-lived but is termed "dysthymia" when it is chronic. Then there is normal or balanced mood, above which comes hypomania (mild to moderate mania), and then severe mania.
Overview of Study:
Major Depression - Treatment Resistant Depression Depressive disorders are not the normal ups and downs that everyone experiences. They are illnesses that affect mood, body, behavior, and mind. Depressive disorders interfere with individual and family functioning. The person with a depressive disorder is often unable to fulfill the responsibilities of spouse or parent, and may be unable to carry out usual job responsibilities. Available medications and psychological treatments, alone or in combination, can help 80 percent of those with depression. With adequate treatment, future episodes may be prevented or reduced in severity. Yet, current evidence indicates that nearly two out of three depressed people do not seek treatment and suffer needlessly. Depression can be devastating to all areas of a person's everyday life, including family relationships, friendships, and the ability to work or go to school. Many people still believe that the emotional symptoms caused by depression are "not real," and that a person should be able to shake off the symptoms if only he or she were trying hard enough. Because of these inaccurate beliefs, people with depression either may not recognize that they have a treatable disorder or may be discouraged from seeking or staying on treatment because of feelings of shame and stigma. Too often, untreated or inadequately treated depression leads to suicide. Studies indicate that depression often co-occurs with medical conditions (e.g., stroke, heart disease, cancer, diabetes, etc.); other psychiatric disorders (e.g., anxiety disorders, eating disorders, etc.); and alcohol and other substance abuse. In such cases, there can be added health benefits from treating the depression. Depression affects nearly 10 percent of adult Americans ages 18 and over in a given year, or more than 19 million people in 1998. Unipolar major depression is the leading cause of disability in the United States and worldwide. Nearly twice as many women (12 percent) as men (7 percent) are affected by a depressive illness each year. Research has also shown that stress in the form of loss, especially death of close family members or friends, may trigger major depression in vulnerable individuals. Points to Consider
Signs and Symptoms Symptoms of depression include sad mood, loss of interest or pleasure in activities that were once enjoyed, change in appetite or weight, difficulty sleeping or oversleeping, physical slowing or agitation, energy loss, feelings of worthlessness or inappropriate guilt, difficulty thinking or concentrating, and recurrent thoughts of death or suicide. A diagnosis of unipolar major depression (or major depressive disorder) is made if a person has five or more of these symptoms and impairment in usual functioning nearly every day during the same two-week period. Major depression often begins between ages 15-30 or even earlier. Episodes typically recur. Some people have a chronic but less severe form of depression, called dysthymia (or dysthymic disorder), that is diagnosed when depressed mood persists for at least two years and is accompanied by at least two other symptoms of depression. Many people with dysthymia also have major depressive episodes. While unipolar major depression and dysthymia are the primary forms of depression, a variety of other subtypes exist. Overview of Study: If this sounds like you, and you’re between the ages of 18 and 65, you may be eligible to participate in a new clinical research study of an investigational medication to treat Major Depression. Fieve Clinical Services is conducting this nationwide clinical study for people with Major Depression. Eligible study participants may receive study-related medical care, study medication, and lab work. Patients who are eligible and participate in this clinical study may gain access to a research treatment which may or may not be effective, and also help others by contributing to medical research.
|
FREE CLINICAL STUDIES
|
