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Cariprazine for Cognitive Improvement in Bipolar Disorder (CARPZ-01 Trial)
CARPZ-01 Trial Summary
This trial is testing whether the drug cariprazine is better than usual treatment at improving cognition in people with bipolar disorder.
CARPZ-01 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowCARPZ-01 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.CARPZ-01 Trial Design
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Who is running the clinical trial?
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- I am not taking medications that increase dopamine or anticholinergics.I am on a mood stabilizer or atypical antipsychotic for mood stabilization, not exceeding the allowed combinations or doses.I am taking two or more antipsychotic medications.I have tried cariprazine before and it didn't work or caused side effects.My current medications have been the same for at least two weeks.I have no known allergies or adverse reactions to cariprazine.I haven't had ECT, DBS in the last 8 weeks, or rTMS, tDCS, or experimental drugs in the last 30 days.I have not had cognitive therapy in the last 3 months.I have been diagnosed with an anxiety disorder.I am a woman who has been postmenopausal for at least a year or am surgically sterile.I understand and can follow the study's requirements and visits.I have a stable health condition without severe brain or cognitive issues, and no abnormal heart test results.I am currently taking medications for cognitive enhancement or specific psychiatric conditions.My health has been stable for the last 4 weeks.I have been diagnosed with Bipolar I Disorder, with or without psychosis.I am between 19 and 65 years old.
- Group 1: Cariprazine
- Group 2: Placebo
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
Do you have any previous experience with Cariprazine?
"There are a total of 8 studies currently underway to research Cariprazine. Out of those, 5 are live clinical trials in Phase 3. Cariprazine is most commonly studied in Bogotá and Texas, but there are 189 research sites for this medication across the globe."
Are the patients who are part of this experiment restricted to a certain age demographic?
"Patients that meet the age requirements of 19-65 and hope to be included in this trial are welcome to apply. There are 597 trials for people over 65 and 36 for those under 19."
Has Cariprazine undergone testing by the Federal Drug Administration?
"Cariprazine has been given a safety ranking of 3 by our analysts at Power. This is because Phase 3 trials, of which this is one, have provided some data to support efficacy as well as multiple rounds of data affirming its safety."
How many people are being treated with this medication in this experiment?
"That is correct, according to the latest information from clinicaltrials.gov, this study is still looking for more participants. The trial was initially posted on 7/7/2021, with the most recent update on 4/25/2022. They are hoping to enroll 30 patients from 2 different locations."
Has this experiment been conducted before?
"Currently, across 12 nations and 58 cities, there are 8 studies still underway for Cariprazine. Allergan conducted the very first clinical trial for Cariprazine in 2019. That initial study included 330 Phase 3 patients and was completed successfully. Since 2019, a total of 18254 trials have been completed."
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