Track topics on Twitter Track topics that are important to you
The purpose of this study is to determine the safety and effectiveness of a long-acting injectable formulation of risperidone in stable bipolar patients randomly switched from their current add-on oral antipsychotic (olanzapine, risperidone, or quetiapine) therapy to long-acting injectable risperidone. The patients switched to long-acting injectable risperidone will be compared to patients who continue on their oral antipsychotic treatment regimen
This an open-label, randomized study. Approximately 40 stable bipolar patients who are on an atypical antipsychotic (olanzapine, risperidone, quetiapine) plus adjunct bipolar treatment consisting of (a maximum or two of lithium, valproate or lamotrigine, and, if applicable, one antidepressant) will be randomized to two arms. In one arm, 25 milligrams of long-acting injectable risperidone will replace the oral atypical antipsychotic as adjunct therapy and in the other arm, patients will continue with their current atypical antipsychotic therapy. Trial duration is 6 months. In the long-acting injectable risperidone arm, the oral atypical antipsychotic will be continued (as supplementation) for 3 weeks after the first injection of long-acting risperidone and then discontinued. Investigators, based upon the patient's response, may increase the dose of injectable risperidone to 37.5 mg after 6 weeks on the 25-mg dose and to 50 mg after at least 4 weeks on the 37.5-mg dose. Risperidone oral supplementation is allowed. In the oral antipsychotic only arm, the oral atypical antipsychotic dose can also be increased as required. The primary efficacy outcome will be measured by changes in the Clinical Global Impression - Severity of Illness subscale (CGI-S), from baseline to endpoint, and will be compared between the treatment groups. Safety will be monitored throughout the study. The primary hypothesis is that patients switched to long-acting injectable risperidone will be able to tolerate this formulation of risperidone and maintain or even improve their reduction in bipolar symptomatology compared with baseline, and compared with subjects who continue in the oral antipsychotic arm. The secondary hypothesis is that patients switched to long-acting injectable risperidone will have a longer time to intervention for a mood episode (either mania or depression) as compared with subjects who continue in the oral antipsychotic arm.
Risperidone, formulated for intramuscular injection, 25 mg every 2 weeks. Patients treated with injectable risperidone continue their original oral atypical antipsychotic (AAP) dose for 3 weeks. Investigators, at their discretion, may increase the dose of injectable risperidone to 37.5 mg after 6 weeks on the 25-mg dose and to 50 mg after at least 4 weeks on the 37.5-mg dose. Study duration is 6 months.
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Janssen-Ortho Inc., Canada
Published on BioPortfolio: 2014-08-27T03:47:57-0400
The purpose of this research study is to evaluate the safety, tolerability, and efficacy (how well the drug works) of risperidone compared to placebo (an inactive drug) in the treatment of...
The purpose of this study is to determine whether quetiapine or risperidone are effective in treating mood symptoms, drug cravings and use in bipolar disorder with concurrent cocaine or me...
The objectives of this study are to study the safety, effectiveness, tolerability and dosing regimen of risperidone, and olanzapine, in the treatment of mania in Bipolar Disorder I and Bip...
The purpose of the study is to evaluate the efficacy of risperidone long-acting injectable in comparison with placebo in the prevention of a mood episode in treatment of patients with bipo...
The purpose of this study is to determine whether the sedating (causing sleepiness) effects of risperidone or quetiapine alter cognitive (person's ability to think, perceive, recognize, re...
Bipolar disorder is a neuropsychiatric disorder that is characterized by fluctuations between manic and depressive phases. Lithium is the original and best mood stabilizing treatment for bipolar disor...
At least half of the cases of bipolar disorder begin in childhood or adolescence. How do you decide whether a young patient's symptoms indicate bipolar disorder? Read this CME Brief Report to learn ab...
It has been suggested that agitated depression (AD) is a common, severe feature in bipolar disorder. We aimed to estimate the prevalence of AD and investigate whether presence of AD was associated wit...
Evidence has shown a significant association between bipolar disorder and prevalence of risky sexual behaviors. However, the relationship between bipolar disorder and risk for sexually transmitted inf...
Metacognition is an important factor in the development and persistence of bipolar disorder. One of the most striking examples of impairment in metacognitive functioning in bipolar disorder is the lac...
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.
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.
A thiazole derivative and atypical ANTIPSYCHOTIC AGENT that functions as a DOPAMINE D2 RECEPTOR ANTAGONIST; SEROTONIN 5-HT2 RECEPTOR ANTAGONIST, serotonin 5-HT7 receptor antagonist, and antagonist of the adrenergic α2A and α2C receptors, as well as a partial SEROTONIN 5-HT1A RECEPTOR AGONIST. It is used in the treatment of SCHIZOPHRENIA and BIPOLAR DISORDER.
Bipolar disorder, also known as manic-depressive illness, is a brain disorder that causes unusual shifts in mood, energy, activity levels, and the ability to carry out day-to-day tasks. Over half of Bipolar cases develops before the age of 25. Bipolar ...
Depression is a serious mental health condition, where sad feelings carry on for weeks or months and interfere with your life. The symptoms include feeling unhappy most of the time (but may feel a little better in the evenings), loosing interest in lif...