View clinical trials related to Bipolar Disorder.
Filter by:Based on highly promising preliminary data, it is proposed to conduct a multi-site randomized controlled trial of a high-intensity ambulatory treatment program for bipolar disorder against standard office-based, physician-centered care. The major characteristics of this program are that it emphasizes (1) aggressive guideline-driven pharmacotherapy, (2) continuity of care with identified primary mental health nurse clinicians supported by psychiatrist back-up, and (3) patient education to improve treatment alliance and illness management skills.
This research protocol seeks to learn more about bipolar disorder in children and adolescents ages 6-17. Researchers will describe the moods and behaviors of children with bipolar disorder and use specialized testing and brain imaging to learn about specific brain changes associated with the disorder. This protocol studies children who have been diagnosed with bipolar disorder, and those who have a sibling or parent with bipolar disorder and are thus considered "at risk" for developing the disorder.
Bipolar disorder is a mood (affective) disorder characterized by the occurrence of alternating feelings of excitement (mania) and depression. It is a common, but serious condition, and potentially life-threatening. Patients are considered to have a rapid cycling form of bipolar disorder if they experience four or more episodes of hypomania (mild degree of mania), mania, and/or depression. Approximately 20% of the patients in bipolar clinics have the rapid cycling form of the disorder. Therefore it can be said that RCBD is not a rare condition and that it can severely impair a patient. These reasons alone justify studying RCBD. However, researchers also believe that information gathered by studying patients with RCBD can be used while studying other patients with different forms of bipolar disorder. The purpose of this study is to screen patients diagnosed as having rapid cycling bipolar disorder to see if they fit the criteria for the diagnosis and to see if they would be interested in participating in other research studies. Patients will undergo diagnostic interviews, physical examination, routine blood tests, EKG (electrocardiogram), and complete self-rating forms as part of the screening process.
The purpose of this research protocol is to screen and enroll individuals who have bipolar disorder and to track each person's course of illness in order to study the long-term course of illness and to elucidate possible clinical and biological predictors of acute and sustained treatment response. As a part of this protocol, subjects will: systematically be administered psychiatric rating scales such as the life-chart method (LCM) for daily assessment of mood, sleep, and behavior; be asked to participate in non-invasive research procedures, such as blood drawing for measurement of thyroid antibodies and intracellular calcium; and be medicated as is clinically appropriate. This protocol also serves as a stepping stone to other protocols such as the comparative acute and long-term efficacy of three antidepressants (#95-M-0129), and the efficacy of omega-3 fatty acids (#00-M-0004), for which separate written informed consents are obtained. Patients in this study are participants in the larger NIMH-Stanley Foundation Bipolar Network (SFBN), which involves six academic sites focused on better understanding the long-term course and treatment of the illness. The current protocol thus serves as an entry point for individuals with bipolar disorder for screening and detailed longitudinal assessment both prior to and in between more formal blind randomized IRB approved treatment protocols.
This study is designed to evaluate repetitive transcranial magnetic stimulation (rTMS) as a potential treatment for depression. In rTMS, a rapidly changing magnetic field passes through your scalp and skull and generates a small electrical pulses in your brain. rTMS at lower intensities has helped some people with depression but we do not know what the results will be in your case using higher intensities, or whether you will be randomized to 3 weeks of high frequency (20 cycles er second), low frequency (1 cycle per second), or inactive (sham)rTMS. You will be assigned to receive one of these types of rTMS over the left front art of your brain five times per week for the three weeks. Each rTMS treatment session should take between 20-30 minutes of actual stimulation, but weekly ratings, memory testing, and blood sampling may require several hours per week. We will also ask you to have brain imaging procedures to see if these will predict response to high vs. low frequency rTMS. If you are randomized to the 3 weeks of sham rTMS, you will have the opportunity to receive one of the active stimulation frequencies for an additional 3 weeks. Responders to any phase will be offered an additional month of rTMS prior to study termination and recommendations of alternative treatments.
The purpose of this study is to improve the understanding of the genetic causes of specific neurologic and psychiatric disorders. The study will focus on conditions of mental retardation, childhood onset schizophrenia, attention deficit hyperactivity disorder (ADHD), atypical psychosis of childhood, and bipolar affective disorder. The study addresses the belief that there may be several genes contributing to the illness. Researchers intend to use several molecular genetic techniques in order to identify the areas of chromosomes containing genes responsible for the development of these disorders. Patients will be selected to participate in this study based on an early age of onset of their condition as well as the severity of the illness and the frequency of the illness among family members. Researchers will collect DNA samples from patients as well as affected and unaffected family members of each patient. The DNA samples collected will be analyzed for a variety of genetic abnormalities including; triplet repeat expansions, chromosome rearrangements, and polymorphisms.
This study will compare the effectiveness of relatively new antidepressants which have different mechanisms of action. Buproprion (Wellbutrin) works on dopamine and the dopaminergic pathway. Sertraline (Zoloft) works as a selective serotonin reuptake inhibitor (SSRI). Venlafaxine (Effexor) works as a mixed serotonin, norepinephrine, and dopamine reuptake inhibitor. Subjects enrolled in this study will be patients diagnosed with a bipolar disorder who are presently taking medication to prevent the symptoms of the disease (prophylactic treatment), but have had breakthrough episodes of depression despite taking their medication. Patients will receive any one of the three antidepressant medications as noted above plus a placebo inactive sugar pill, in order to mask which antidepressant is being prescribed) in addition to their regular medication for bipolar disorder. All of the doses will be calculated as effective for the treatment of a unipolar major depressive disorder. The patient will continue receiving the medication for ten weeks. The effectiveness of the drug treatment will be measured by using three different scales; 1. Inventory for Depressive Symptoms - Clinicians form (IDS-C) 2. Clinical Global Impression scale(CGI-BP) 3. Life Charting Methodology (LCM) Patients who do not respond to their medication within ten weeks from the beginning of the study will be considered as non-responders and be offered the opportunity to start the study again, taking one of the two remaining medications. For example, if a patient was assigned to take Wellbutrin but it was ineffective, he/she could re-enter the study and be given either Zoloft or Effexor. Patients that do respond in the first ten weeks of the study will be eligible to continue taking the medication for one year to assess the long term effectiveness of the drug on preventing episodes of depression and to assess for any possible differential induction of mania.
For many years researchers have been trying to better understand the regulation of sleep and activity by studying circadian (daily) rhythms of human beings. It appears that the hormones estrogen, progesterone, and testosterone play a role in the regulation of circadian rhythm in animals. Researchers believe these hormones may also play a similar role in the regulation of human circadian rhythms. Little research has been conducted on how these hormones affect human circadian rhythms. This study is designed to learn more about how specific hormones influence men and women's daily rhythms. This study will use women from another research study being conducted at the NIMH called, "The central nervous system effects of pharmacologically induced hypogonadotropic hypogonadism with and without estrogen and progesterone". Male subjects will be recruited from another NIMH study called, "The central nervous system effects of pharmacologically induced hypogonadotropic hypogonadism with and without testosterone replacement". In order to test the possibility that gonadal steroids (estrogen, progesterone, and testosterone) change circadian rhythms and the sleep-wake cycle in humans, participants will undergo chronobiologic evaluations. The chronobiologic evaluations will look at sleep and rest periods, activity as measured by a wrist monitor, and 24 hour inpatient electroencephalograph (EEG), rectal temperature, and melatonin monitoring.
This research study is the continuation of a study started more than 20 years ago. The study was designed to explore the effect that depressed parents have on their children and to better understand the factors that contribute to depression development and maintenance. The study will continue to investigate if children have certain characteristics in early and middle childhood that predict the later development of psychological disorders. In addition, the study will continue looking at the processes responsible for the development of children of parents with and without affective (mood) disorders.
This study will examine the effectiveness of omega-3 fatty acids, compounds found in plants and fish, in treating bipolar disorder. Some studies have indicated that omega-3 fatty acids may be effective in treating mood disorders. For example, one investigator has shown a correlation between the prevalence of major depression and the amount of fish consumed per capita worldwide. Others have found decreased amounts of EPA (one of the active ingredients in omega-3 fatty acids) in the red blood cells of patients with major depression. And a recent small study of patients with bipolar illness indicated that omega-3 fatty acids prevented relapses, especially of depression, in patients. Patients with bipolar disorder who are not benefiting satisfactorily on their current medications are eligible to participate in this study. Candidates will be screened with a psychiatric evaluation, routine blood tests, a urine test and other tests needed to monitor medications. Participants will be randomly assigned to one of two groups: one group will receive 6 grams of omega-3 fatty acid every day for 16 weeks; the second will receive a placebo (inactive capsule). In addition, patients in both groups will continue to take their previous medications. Every 2 weeks, all patients will have their vital signs checked and be evaluated for side effects and mood changes. At the end of the 16-week study period, all patients will be given the opportunity to continue in the study for another 8 months and receive active drug (omega-3 fatty acid). Patients who continue will be evaluated once a month and will have blood drawn on the last visit for routine tests.