754 Clinical Trials for Various Conditions
This study will evaluate the effectiveness of interpersonal and social rhythm therapy (IPSRT) versus clinical status and symptom response therapy (CSSRT) in reinforcing the treatment of bipolar disorder in individuals who are currently undergoing medication treatment for the disorder.
This study will examine how various factors, such as psychiatric symptoms, gender, quality of life, and attitudes toward medication, affect treatment adherence in individuals with rapid cycling bipolar disorder.
This study will examine how various factors, such as psychiatric symptoms, gender, social support, substance use, and attitudes toward medication, affect treatment adherence in individuals with bipolar disorder.
A long-term study of current treatments for bipolar disorder, including medications and psychosocial therapies.
Children or teens with mood swings or depression who have a parent with bipolar disorder are at high risk for developing bipolar disorder themselves. This study will test a family-based therapy aimed at preventing or reducing the early symptoms of bipolar disorder in high-risk children (ages 9-17). In a randomized trial, the investigators will compare two kinds of family-based treatment (one more and one less intensive) on the course of early mood symptoms and social functioning among high-risk children followed for up to 4 years. The investigators will examine the effects of family treatment on measures of neural activation using functional magnetic resonance imaging.
The study will determine if individuals with co-occurring bipolar disorder and alcohol dependence report reduced alcohol consumption, improvement in mood symptoms, and cognitive performance if treated with lamotrigine plus their usual mood stabilizing medications relative to subjects treated with placebo plus usual mood stabilizing medications over a 16 week period.
Pediatric Bipolar Disorder (BD) is uncommon in children. Its symptoms include periods of manic behavior (being overly happy or giddy, feeling grandiose, feeling a decreased need for sleep, having too much energy, moving more than usual, talking fast, having speeded-up thoughts and other symptoms). Sometimes there also is depression (extreme feelings of sadness or irritability, not taking pleasure in things, even ones that used to be enjoyable, feeling worthless or guilty, sleeping too much or having trouble getting to or staying asleep, feeling slowed down or restless, having wishes to be dead or suicidal ideas, and other symptoms). Pediatric BD is often difficult to treat; children may respond only partially to the medications now available or have too many side effects to tolerate them. Riluzole is a medication that is thought to work on a brain chemical called glutamate that may be involved in symptoms of depression and BD. Previous research studies have shown that riluzole may help adults with BD who have depression and adults who have depression, anxiety disorders, or obsessive-compulsive disorders. Riluzole may also be helpful for children with obsessive-compulsive disorder. However, it has never been given to children with BD. This study will evaluate the effectiveness of riluzole in 80 patients between 9 and 17 years of age who have BD and symptoms of anxiety. Participants must have tried at least two other medications that have not been effective. The study will consist of four phases carried out over 4 to 5 months. Most children will be inpatients at the Pediatric Behavioral Health Unit for at least part of the study. In Phase 1, each patient will undergo blood and urine tests, and will gradually taper off his or her medication. The duration of this phase depends on the medication that the patient was receiving before starting the study. In Phase 2, the patient will remain off all medication for 1 week. Throughout this time, patients will be monitored carefully and medication will be restarted if needed. In Phase 3, which lasts 8 weeks, patients will be assigned randomly to receive only riluzole or only a placebo. Those who receive riluzole will have the dose adjusted as needed. Patients and families will be informed of which drug they were on at the end of this phase. Patients who improved on riluzole may continue to receive it from NIH for 1 month and will then be prepared for discharge from the study. Patients who received placebo and improved, and those who received riluzole but did not improve, will be treated with standard medications as appropriate and prepared for discharge from the study. Phase 4 is for patients who received placebo and did not improve. They will be given the chance to try riluzole for 8 weeks and, if it is effective, continue it for an additional 4 weeks while they prepare to be discharged from the study. Patients will not be able to receive riluzole at the National Institutes of Health after the completion of the study. However, the child's doctor may be able to prescribe riluzole as an off-label use. Most patients will be admitted to the Pediatric Behavioral Health Unit at the National Institutes of Health Clinical Center during the medication withdrawal part of the study (Phases 1 and 2). From Phase 3 on, a patient may participate as an inpatient, outpatient, or in day treatment, depending on what is in his or her best interests. All participants in this study will be invited to also enroll in the National Institute of Mental Health protocol 00-M-0198, The Phenomenology and Neurophysiology of Affective Dysregulation In Children And Adolescents With Bipolar Disorder. Some research tests for that protocol will be done during the medication-free period of this protocol. ...
This study will assess the effects of bipolar disorder on brain activity and will determine if medication changes the brain activity in people with bipolar disorder.
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. ...
This twelve month, open-label study considers the effect of Risperdal (risperidone) versus Zyprexa (olanzapine) on weight gain, physical health, and outcome in a population of those diagnosed with schizophrenia, schizoaffective disorder, major depression or bipolar disorder with psychotic features. This study evaluates symptom response as well as general health indicators such as body mass index, glucose, prolactin, and cholesterol levels at baseline, month (M)1, M3, M6 and M12.
The goal of this randomized clinical trial is to be adequately powered to evaluate the effect of ketogenic metabolic therapy on the quality of life in serious mental illness, schizophrenia, bipolar disorder, major depressive disorder.
The purpose of this study is to assess antidepressant efficacy differences between ALTO-100 and placebo during the Double-Blind period in patients with bipolar disorder I or II with current major depressive episode, when used adjunctively to a mood stabilizer, related to patient characteristics. Additionally, safety, tolerability, and efficacy will be assessed in a subsequent open label treatment period.
Mood disorders, such as depression and bipolar disorder, are difficult to treat. One reason is that there are no objective ways to measure how these disorders affect the body and respond to different treatments. In this study, researchers want to perform tests on people undergoing clinical care for mood disorders. The purpose is to understand the experience of receiving treatment for depression, bipolar disorder, and suicide risk. We also hope that this study will help us to predict which medications will improve thoughts of suicide. People 18 years or older who are receiving treatment for depression, bipolar disorder, or suicide risk may take part in this study. Participants must have also been enrolled in protocol 01-M-0254. This study will be conducted at the NIH Clinical Center in Bethesda, MD. The study typically lasts up to 12 weeks, but may last longer if a participant s treatment continues past that time. Participants will have weekly interviews and questionnaires while they are being treated for their mood disorder. Other tests are optional and include psychological testing, blood draws, sleep tests, and imaging scans. These will be done at the start and the end of research participation.
This is a randomized, controlled clinical trial to assess the effects of the ketogenic diet in combination with treatment as usual on brain energy metabolism and psychiatric symptoms in individuals with first episode bipolar disorder and schizoaffective disorder.
This study evaluates the efficacy of an accelerated schedule of theta-burst stimulation for treating manic episodes in bipolar disorder. In this open-label study, all participants will receive accelerated theta-burst stimulation.
The investigators will test the hypothesis that inhaled xenon will produce a rapid improvement in depressive symptoms in patients suffering from treatment-resistant depression. Specifically, the investigators will conduct a parallel randomized, double-blind crossover study that will compare the effects of xenon-oxygen (35:65 ratio by volume) added to treatment as usual (X-TAU group) to the effects of nitrogen-oxygen (35:65 ratio by volume) added to treatment as usual (N-TAU group). A total of 20 severely depressed patients, 10 with major depressive disorder (MDD) and 10 with Bipolar Depression (BP), will be exposed in random order to N-TAU and X-TAU in a double-blind protocol.
Lithium is highly effective in the treatment of bipolar disorder. This study aims to investigate, for the first time, the impact of lithium monotherapy on the structural and functional connectivity of the brain using MRI imaging.
Inositol hexaphosphate (IP6, also called inositol hexakisphosphate, and phytic acid) is a naturally occurring phosphorylated derivative of myo-inositol. Myo-inositol has shown preliminary evidence of efficacy in controlling mood symptoms, and good tolerability in bipolar disorder in some studies, but failed to establish efficacy in subsequent meta-analyses. In the investigators proposed work, the investigators plan to orally administer the calcium/magnesium salt of IP6 (2,000-3,000 mg daily in two divided doses) to paid research subjects with a diagnosis of bipolar disorder who are in a depressed state, and who have failed an adequate course of treatment with lithium monotherapy. The investigators hypothesis is that IP6 may be similar to myo-inositol in terms of relieving depression, but more potent and effective. Our aim is conduct a preliminary pilot study in 30 subjects (15 treated with IP6, 15 treated with lamotrigine, an active comparator) to assess the efficacy and tolerability of IP6 as an adjunctive treatment to lithium, the mood stabilizer most commonly used to treat bipolar disorder.
Depression and bipolar disorder are major public health concerns for adolescents today. Teenage depression and bipolar disorder are associated with social isolation, family stress, school failure, substance abuse and suicide. Screening for depression and bipolar disorder so that treatment can be started early in the course of illness is an urgent public health priority. Many teens with bipolar disorder are incorrectly diagnosed as having unipolar depression. It is critical that adolescents receive proper screening and assessment that leads to an accurate diagnosis and treatment. An efficient, cost-effective, blood-based screening program could be performed on an annual or semi-annual basis to potentially detect depression and then differentiate between unipolar and bipolar depression. If this type of screening were able to detect a significant percentage of teens with depression or bipolar disorder, the positive impact on U.S. public health would be substantial. The purpose of this study is to conduct a pilot study to assess the probability of detecting adolescent unipolar and bipolar depression through blood samples.
The purpose of the present study is to evaluate a neuroplasticity-oriented, computer-based cognitive remediation treatment program in patients with bipolar disorder and its effects on cognitive deficits and community functioning compared to an active, computer-based control.
Forty subjects with bipolar disorder who are not receiving a mood-stabilizing medication for the treatment of their illness will participate in this study. The study aims to evaluate how decision-making is affected by treatment for bipolar disorder. Prior to beginning treatment, patients will complete questionnaires and a one-hour computer-administered assessment of decision-making. Differences between pre-post decision-making outcomes will be evaluated to examine whether the neuroeconomic concepts of risk aversion, loss aversion, risk tolerance and delay discounting are affected by treatment. The overall goal of this study will be to identify whether decision-making in people with bipolar disorder is affected by treatment. Specifically the investigators will compare decision-making characteristics among bipolar patients prior to treatment with how these decision-making characteristics change over the course of 6 weeks of standard medication therapy for bipolar disorder. A total of 6 decision-making tasks and one control task will be administered via computer to eligible subjects. The investigators will evaluate decision-making under varying conditions of reward, risk, and uncertainty and over time. The investigators hypothesize that decision-making will improve across these assessments after 6 weeks of treatment.
The purpose of this study is to screen for peroxisome defects in child and adolescent offspring of Bipolar Disorder I (BD-I) parents at different stages of risk for transitioning to mania and following the onset of mania. Prediction 1: Youth with an elevated risk for developing BD-I and first-episode manic patients will exhibit graded deficits in measures of peroxisomal function compared with healthy controls. Prediction 2: Indices of peroxisomal function will be correlated with Red Blood Cells Docosahexaenoic acid (DHA) composition. Prediction 3: Graded deficits in measures of peroxisomal function will be inversely correlated with manic and depression symptom severity scores.
Psychoeducation has been the only group treatment developed for bipolar disorder thus far. Deficits in emotion regulation, a core impairment among patients with bipolar disorder, are not directly addressed in this treatment. The objective of this study is to develop a group treatment for bipolar disorder that focuses on emotion regulation strategies (Enhancing Emotion Regulation; EER). This study will examine the efficacy of this treatment using an open trial design. It is hypothesized that patients who receive EER will show a reduction in mood symptoms and improvement in well-being. Reductions in emotion regulation difficulties will predict improvements.
To assess the acute and long-term bimodal efficacy of QTP, as an adjunct to ongoing treatment with lithium (Li) or divalproex (DIV) or lamotrigine (LAM) or any combination of the three thereof, in a group of patients with an index episode of a mixed state in BD.
The purpose of the study is to investigate the efficacy of mindfulness-based cognitive-behavior therapy (MBCT) for improvement of symptoms associated with bipolar disorder, by comparing MBCT to supportive psychotherapy. Patients who participate in this study will be randomly assigned to receive either 1. state of the art group MBCT, or 2. supportive group psychotherapy (which is considered part of the standard care available to patients at MGH).
Open-label safety study of oral olanzapine treatment in adolescents, aged 13 to 17 years, with bipolar I disorder (manic or mixed episodes) or schizophrenia.
The goal of the proposed clinical trial is to assess the effect of oral cytidine and omega-3 fatty acids (O3FA) on bipolar disorder symptoms. This study is a 4-month, randomized, parallel-group, double-blind, placebo-controlled pilot study of a combination of cytidine and omega-3 fatty acids in 90 recently ill subjects with bipolar disorder. During the 16 week period of the study, subjects are assigned to one of three groups: 1) omega-3 fatty acids + cytidine supplementation, 2) omega-3 fatty acids supplementation alone, and 3) placebo supplementation.
The purpose of this study is to understand the efficacy of light therapy for bipolar depression.
The purpose of this research study is to learn more about cognitive deficits in people with certain mood disorders. The mood disorders are Major Depressive Disorder (MDD) and Bipolar disorder, depressed type. Cognitive deficits are problems with things like thinking and memory. People with cognitive deficits may have problems concentrating and paying attention. When talking, they may have trouble recalling a word they want to say. They may think slowly and have problems remembering things. These deficits can affect an individual's ability to work and function socially. Cognitive deficits that occur with depression may increase the risk of a relapse of major depressive disorder. We want to study the course of cognitive impairment in subjects as they are receiving treatment for their depression. We want to find out if their cognitive deficits get better, worse, or stay the same. We also want to learn more about a stress hormone called cortisol that is produced in the body. We want to study the relationship between cortisol and cognitive impairment. Recent research has shown that cognitive impairment may be more severe in people who have high levels of cortisol in their blood. We will also measure the levels of a protein in your blood called brain-derived neurotrophic factor (BDNF). BDNF helps the growth of new brain cells. It appears that the growth of new brain cells lessens when people are depressed. Treatment with antidepressant medications may cause BDNF levels to increase and return to normal. We are interested in studying the relationship between BDNF levels and cognitive impairment throughout treatment.
The purpose of this study is to investigate the efficacy of allopurinol as an augmentation agent for the prevention of mania in bipolar disorder patients with currently stable mood.