Track topics on Twitter Track topics that are important to you
THIS STUDY HAS BEEN DISCONTINUED.
The study is designed to evaluate the safety and efficacy of fluoxetine for treating children and adolescents with Bipolar Disorder who are experiencing an episode of major depression while being treated with a mood stabilizer. The study involves a 2-week assessment period. Patients who are on stable, therapeutic doses of lithium or valproate and continue to have depression will be randomized to a 12-week treatment of fluoxetine or placebo. Those who respond favorably to treatment will be followed openly for an 18-week continuation phase.
This NIMH sponsored study is being done to determine the safety and efficacy of a selective serotonin reuptake inhibitor (SSRI), fluoxetine (Prozac), compared to placebo in the treatment of children and adolescents with bipolar disorder who, while taking a mood stabilizer, are currently experiencing an episode of major depression. Bipolar disorder is a recurrent, episodic illness with key features of severe mood swings from one extreme (depression) to the other extreme (mania). These mood swings and associated symptoms are not similar to the normal mood changes that individuals experience from time to time. A person suffering from bipolar disorder, while in an episode of depression or mania, experiences problems in their functioning in several different areas in his or her life such as interpersonal, social, academic and occupational. Symptoms of depression include sad or irritable mood, sleep and appetite disturbances, trouble concentrating, inability to enjoy things that are normally fun, feelings of guilt, low self-esteem, withdrawal from family and friends, suicidal ideation. Symptoms of mania include extremely happy or irritable mood, little need for sleep, poor judgment, continuous high energy, overconfidence, racing thoughts, increase in social interactions, frequent or constant thoughts about sex. There are varying degrees and types of bipolar disorder.
Pediatric bipolar disorder is now recognized as a significant health problem. Studies of adults have shown that approximately 40% of bipolar patients started to suffer from this disorder during their teens. Bipolar disorder is usually treated with medications, such as lithium or valproate (Depakote), to stabilize the mood swings. Sometimes people with bipolar disorder experience depression, even when they are taking a mood stabilizer medication. When this happens, an antidepressant medication may need to be added to treat the depressive symptoms. The current practice for treatment of bipolar disorder in children and adolescents in the depressed phase follows treatment guidelines developed for adults, but it is unknown whether these treatment strategies are appropriate for children and teens. Few studies have been done in youth.
Fluoxetine has been approved by the Food and Drug Administration (FDA) for treatment of depression, bulimia, and obsessive-compulsive disorder in adults, but not in children or adolescents. Previous research has shown that fluoxetine is an effective treatment for periods of depression, however, in this study the investigators are evaluating whether it is effective for periods of depression associated with bipolar disorders. In this study, about 100 children and adolescents (ages 8-18 years) who are taking lithium carbonate or valproate (Depakote) and are experiencing depression will be randomized to receive fluoxetine (Prozac) or placebo for 12 weeks. Weekly visits to the clinic are necessary for participation to ensure safety. At the end of the 12 weeks there is an 18-week open treatment period, which will involve clinic visits at least monthly. Those who were taking fluoxetine and improved will continue taking the fluoxetine during this time period. Those who did not improve will either receive an increased dose of fluoxetine or will be assigned to a different medication. Those who were taking placebo and did not improve will be offered treatment with fluoxetine and those who improved with placebo will continue taking only lithium or valproate.
Control: Placebo Control, Masking: Double-Blind, Primary Purpose: Treatment
National Institute of Mental Health (NIMH)
Published on BioPortfolio: 2014-08-27T03:58:06-0400
This 62-week study will compare the safety and effectiveness of fluoxetine (Prozac®), lithium, the combination of these two medications, and placebo in treating and preventing recurrent d...
This will be a 12-week open-label pilot treatment study for children and adolescents (ages 6-17) who meet DSM-IV criteria for bipolar disorder (BPD) and obsessive-compulsive disorder (OCD)...
Bipolar disorder is associated with alterations of chemicals in the brain, including one named serotonin. Treatment of depression in bipolar disorder can be accomplished by increasing sero...
This study employs functional magnetic resonance imaging to compare brain activation patterns during a depressive episode in patients diagnosed with bipolar disorder, major depressive diso...
This will be a controlled, randomized, double-blind and double-dummy study on the treatment augmentation strategy for obsessive compulsive disorder patients non-respondent to first line ph...
Neuroimaging studies of adults with bipolar disorder (BD) have identified several BD subtype distinctions, including greater deficits in prefrontal gray matter volumes in BD-I (bipolar I disorder) com...
To assess predictors of the diagnosis of bipolar disorder is important since it is known that the early diagnosis is associated with a better response to the treatment. Thus, the aim of this systemati...
Bipolar disorder has a wide range of clinical manifestations which may progress over time. The aim of this study was to test the applicability of a clinical staging model for bipolar disorder and to g...
Bipolar disorder (BD) is difficult to distinguish from other psychiatric disorders. Neuroimaging studies can identify objective markers of BD risk.
Many people with a diagnosis of bipolar disorder associate positive qualities with their condition, which may place a ceiling on the effectiveness of treatment and the likelihood of recovery. However,...
A major affective disorder marked by severe mood swings (manic or major depressive episodes) and a tendency to remission and recurrence.
A dibenzothiazepine and ANTIPSYCHOTIC AGENT that targets the SEROTONIN 5-HT2 RECEPTOR; HISTAMINE H1 RECEPTOR, adrenergic alpha1 and alpha2 receptors, as well as the DOPAMINE D1 RECEPTOR and DOPAMINE D2 RECEPTOR. It is used in the treatment of SCHIZOPHRENIA; BIPOLAR DISORDER and DEPRESSIVE DISORDER.
An element in the alkali metals family. It has the atomic symbol Li, atomic number 3, and atomic weight 6.94. Salts of lithium are used in treating BIPOLAR DISORDER.
The first highly specific serotonin uptake inhibitor. It is used as an antidepressant and often has a more acceptable side-effects profile than traditional antidepressants.
INTERNEURONS of the vertebrate RETINA containing two processes. They receive inputs from the RETINAL PHOTORECEPTOR CELLS and send outputs to the RETINAL GANGLION CELLS. The bipolar cells also make lateral connections in the retina with the RETINAL HORIZONTAL CELLS and with the AMACRINE CELLS.
Pediatrics is the general medicine of childhood. Because of the developmental processes (psychological and physical) of childhood, the involvement of parents, and the social management of conditions at home and at school, pediatrics is a specialty. With ...
Psychiatry is the study of mental disorders and their diagnosis, management and prevention. Conditions include schizophrenia, severe depression and panic disorders among others. There are pharmaceutical treatments as well as other therapies to help...