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Cariprazine for Bipolar Disorder
Study Summary
This trial will look at how well a recently approved medication, cariprazine (Vraylar), works to treat bipolar depression by looking at brain imaging with PET scans before and during treatment.
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.Side effects data
From 2011 Phase 3 trial • 497 Patients • NCT01058668Trial Design
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- I have bipolar I disorder and am currently experiencing a major depressive episode.I've gotten worse in the past when stopping any of my current medications.I have not had electroconvulsive therapy in the last 6 months.I do not have any major ongoing illnesses or conditions that would interfere with the treatment.I am under 33 and have a close family member with schizophrenia.I am between 18 and 60 years old.I have been exposed to radiation at work or through medical tests but below the FDA's yearly limit.I am experiencing severe depression, as measured by a specific depression scale.I understand the study and have given my consent.I have not been diagnosed with major psychiatric disorders like schizoaffective disorder or current psychotic depression.I've tried cariprazine for 6 weeks or more without success and had bad side effects.I've been on antidepressants or antipsychotics without improvement and haven't changed my mood stabilizer dose recently.
- Group 1: Cariprazine 1.5 mg
- Group 2: Cariprazine 3 mg
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
- 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
Is this study pioneering a new medical field?
"Since 2019, Cariprazine has been studied and tested by Allergan in a Phase 1 trial involving 330 participants. This initial research led to its approval for clinical use. Currently, 8 trials are underway with locations spanning 12 nations across 58 cities."
Are recruitment efforts for this study still underway?
"At the present moment, this clinical trial is not in a recruitment phase. Initially posted on December 1st 2022 and revised October 12th 2022, there are no open slots for participation. Nevertheless, 1385 other trials have available spots to join right now."
What criteria must potential participants fulfill to qualify for this experiment?
"To be considered for this medical trial, prospective participants must meet the criteria of having depression and being between 18-60 years old. At present, a total of 8 individuals are needed to complete the study."
What is the approximate participant count for this clinical experiment?
"Unfortunately, this medical study is not presently accepting participants. The trial was first posted on December 1st 2022 and its details were last updated in mid-October of the same year. If you are looking for alternative studies, 1377 depression trials and 8 Cariprazine clinical studies are recruiting at present."
Could you please enumerate the earlier research efforts with regards to Cariprazine?
"Presently, 8 medical trials are underway for Cariprazine. Of the total studies being conducted, 5 have advanced to Phase 3 and 189 sites across the world are partaking in this research with a majority of these locations based in Nis, New york."
Is the current research study allowing adults to participate?
"This study is accepting individuals aged 18 and above, up to the age of 60."
What potential risks are associated with taking Cariprazine?
"The safety of Cariprazine has been established in a Phase 4 trial, thus earning it the highest score - 3 - on our team's scale."
Who else is applying?
What state do they live in?
What portion of applicants met pre-screening criteria?
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