Track topics on Twitter Track topics that are important to you
Many patients who have recently received a diagnosis of schizophrenia (e.g., "first-episode schizophrenia") respond very well to their antipsychotic medication when they are acutely ill. Once they are more stable, research has shown that first-episode patients need to remain on their antipsychotic medication. Follow-up studies show that stopping medication prematurely is the most common cause of relapse and readmission. It is important to have new ways to help patients stay stable in the community in order for them to continue on with their rehabilitation and recovery process.
Over the last decade, new antipsychotic medications have been developed that are more effective and have fewer side effects than older antipsychotics. The new medicines are often called "atypical", and were only available by pill or capsule for long-term treatment. Most recently, one of the atypical medications - risperidone - became available as a long-acting injection that can be given once every 2 weeks.
The hypothesis of this study is that patients recovering from an acute episode and who then go on to receive a long-acting version of atypical antipsychotic medication (long-acting risperidone microspheres) will stay on their medications for longer than those who take their atypical medication (any available first-line atypical) in the oral (pill) form.
Overview: Before the atypicals were introduced, some of the older antipsychotics were available in oral (pill or capsule) and long-acting (depot) versions. Despite the potential advantages of the depot versions, in those days clinicians in the United States have historically limited the use of long-acting, "depot" antipsychotics to their most treatment-resistant, chronic, patients. Therefore, most clinicians did not routinely consider starting a long-acting antipsychotic early in the course of treatment, such as after the first-episode of schizophrenia.
This whole issue was less relevant after the atypical medications came out, because they were only available in oral versions for long-term treatment. Now that one of the atypical medications (risperidone) is available for use in the United States, the issue of appropriate use of oral vs. long-acting atypical is now very relevant to clinical practice.
For first episode patients, there are been two issues that suggest that the route of medication delivery is an important area to study. First is that almost all first-episode patients will stop their medication too soon. Second, a there now is atypical antipsychotic available in a long-acting preparation (long-acting risperidone, but this option is not often used right away after a first episode, so there is little guidance for clinicians about the effectiveness of long-acting antipsychotics used right away after a first-episode.
Methods: This study compares the effectiveness of the long-acting route of medication to improve adherence and reduce relapse among patients who have been recently diagnosed with schizophrenia or a related psychotic disorder. After patients are stabilized with an atypical antipsychotic and have received patient and family psychoeducation, consenting patients will be randomized to a prospective, random-assignment open-label study comparing any available first-line oral atypical antipsychotic to long-acting risperidone for the maintenance treatment of patients recovering from acute treatment of first-episode schizophrenia.
This study is divided into three study phases. Study Phase I is the acute phase, where consenting patients would be given an acute open-label trial of an oral antipsychotic. Patients who respond within a maximum of 12 weeks to acute therapy will then be invited to participate in Phase II of the study. Patients agreeing to Phase II will then be randomized into staying on their oral antipsychotic medication vs. switching to a long-acting atypical antipsychotic (long-acting risperidone). Patients would be followed for 12 weeks to determine whether or not they accept a recommendation of long-acting antipsychotic or continued oral antipsychotic. Then patients enter into Study Phase III, where they are followed for at the remainder of the year. We want to learn how often patients will accept their doctor's recommendation of a long-acting injection, whether persons taking their antipsychotic medication in long-acting form do better in terms of willingness to stay on their medication, or have better symptom control or fewer side effects, than persons where the doctor recommends the medication in oral (pill) form.
Summary: Patients recently diagnosed as suffering from schizophrenia, e.g. the "first-episode" patient might benefit from an atypical antipsychotic given in a long-acting route of drug- delivery. However, long-acting antipsychotic therapy is not routinely considered in first-episode patients. Studying the acceptance and ultimate effectiveness of a long-acting atypical antipsychotic would be very helpful in understanding how to help patients stay stable and ultimately prevent a revolving door pattern that, if it continues, can be devastating to the recovery process.
Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
atypical antipsychotics:oral vs. long-acting route, Family Psychoeducation
SUNY Downstate Medical Center
Active, not recruiting
State University of New York - Downstate Medical Center
Published on BioPortfolio: 2014-07-24T14:26:59-0400
The primary purpose of the study is to compare the rate of hospitalization associated with psychotic relapse in participants with schizophrenia treated one year before with oral antipsycho...
Interventional, multicenter, open-label, 20 weeks study - To identify efficacy and safety in switching from oral aripiprazole to Abilify Maintena. - To identify efficacy and safety...
Patients who have schizophrenia, schizoaffective disorder, a psychotic disorder, and are being treated with a medication called Risperidone Long Acting Injectable medication or another ant...
Evaluation of Efficacy and Safety of Long-acting Risperidone Microspheres in Patients With Schizophrenia or Other Psychotic Disorders When Switching From Typical Antipsychotic (Oral/Depot) or Atypical Oral Other Than Risperidone
The purpose of this study is to evaluate the efficacy, tolerability and safety of patients on long-acting Risperidone microshpheres injection. The major advantage of long-acting injection ...
The purpose of this study is to assess the efficacy (how well the drug works; primarily through the time to relapse) of long-acting injectable paliperidone palmitate compared to treatment ...
Do you consider long-acting injectable (LAI) antipsychotics when selecting among treatments for schizophrenia? Take part in this CME activity to review the evidence for LAIs vs oral medications and to...
Although second generation long-acting injectable antipsychotics (SG-LAIAs) have been approved and are widely used in adults, there is limited evidence for the use of long-acting formulations in child...
To estimate the budget impact (BI) of introducing aripiprazole once-monthly 400 mg/300 mg (AOM 400) in the maintenance monotherapy treatment of bipolar I disorder versus long-acting injectables, oral ...
Long-acting injectable (LAI) antipsychotics have the potential to improve adherence and outcomes for patients with serious mental illness but are underused. Watch this Webcast to learn how to identify...
Oral pre-exposure prophylaxis (PrEP) prevents HIV infection in men who have sex with men (MSM); however, adherence is an ongoing concern. Long-acting injectable PrEP is being tested in phase 3 trials ...
Coumarin derivative that acts as a long acting oral anticoagulant.
Nutritional support given via the alimentary canal or any route connected to the gastrointestinal system (i.e., the enteral route). This includes oral feeding, sip feeding, and tube feeding using nasogastric, gastrostomy, and jejunostomy tubes.
A genus of coccidian parasites in the family EIMERIIDAE. Cyclospora cayetanensis is pathogenic in humans, probably transmitted via the fecal-oral route, and causes nausea and diarrhea.
An insulin preparation that is designed to provide immediate and long term glycemic control in a single dosage. Biphasic insulin typically contains a mixture of REGULAR INSULIN or SHORT-ACTING INSULIN combined with a LONG-ACTING INSULIN.
A genus of small, circular RNA viruses in the family ASTROVIRIDAE. They cause GASTROENTERITIS and are found in the stools of several vertebrates including humans. Transmission is by the fecal-oral route and there are at least eight human serotypes. The type species is Human astrovirus.
Schizophrenia is a common serious long-term mental health condition that affects 5 in 1000 in the UK. It causes a range of different psychological symptoms; hallucinations, delusions, muddled thoughts based on the hallucinations or delusions and ch...
Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...