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Aripiprazole Once-Monthly vs Oral Antipsychotics for Schizophrenia
Study Summary
This trial compares an injection of aripiprazole once-monthly to standard care oral antipsychotics for non-adherent outpatients with schizophrenia. The goal is to see which treatment helps people take their medicine more regularly and have more positive outcomes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- Group 1: Aripiprazole Once-Monthly
- Group 2: Standard of Care
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What adverse effects may result from the utilization of Aripiprazole Once-Monthly?
"The risk profile of Aripiprazole Once-Monthly is rated at 3, as this medication has received FDA approval and entered Phase 4 trials."
Are there any open recruitment opportunities for this clinical trial?
"The information on clinicaltrials.gov implies that this trial is no longer actively recruiting for participants, as the last update was made back in June of 2015; however, there are 388 other medical trials seeking volunteers at present."
Is the enrollment of elderly individuals encouraged in this medical trial?
"The age requirements for enrolment in this trial are 18 to 60. Meanwhile, there are 55 clinical trials that accept patients under the legal threshold and 199 studies open to elderly individuals above 65 years of age."
Who is eligible to participate in this clinical research endeavor?
"This trial is recruiting two-hundred participants aged 18 to 60 with a current diagnosis of schizophrenia that has been present for at least six months. The inclusion criteria requires they are able to provide written informed consent, understand the nature and requirements of the study, read and comprehend text in order to complete assessments scales, have been prescribed a single oral antipsychotic medication for three months prior to screening, and comply with birth control regulations if applicable."
Are there any preceding investigations of the efficacy of Aripiprazole Once-Monthly?
"Currently, 54 clinical trials examining Aripiprazole Once-Monthly are underway. Of these active studies, 15 have progressed to Phase 3. Toronto is the primary research locus for this particular treatment; however, there are 1271 other locations conducting investigations on its efficacy and safety."
What medical benefits does Aripiprazole Once-Monthly typically provide?
"Aripiprazole Once-Monthly is commonly utilized to mitigate irritability. It can also be a viable treatment option for post traumatic stress disorder (PTSD), dementia, and Alzheimer's disease."
How many individuals are engaged in this medical study?
"Unfortunately, this clinical trial is not open to recruitment at the moment. The listing was first published on December 1st 2014 and last modified on June 3rd 2015. However, there are 334 trials actively looking for people with schizophrenia and 54 studies welcoming individuals taking Aripiprazole Once-Monthly as part of their treatment regimen."
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