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Atypical Antipsychotic
Cariprazine for Cognitive Improvement in Bipolar Disorder (CARPZ-01 Trial)
Phase 3
Recruiting
Led By Lakshmi N Yatham, MBBS,MRCPsyc
Research Sponsored by Jayasree Basivireddy
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Females who are postmenopausal for at least 1 year before the screening visit (confirmed by an FSH test) or are surgically sterile
Clinically stable during the last 4 weeks, as assessed by clinical interview, prior to the randomization visit
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights
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.
Who is the study for?
This trial is for adults aged 19-65 with Bipolar I Disorder, who are stable on mood stabilizers or antipsychotics, and have cognitive impairments but no other major psychiatric disorders. Participants must not be taking certain medications like multiple antipsychotics or stimulants, and women of childbearing age should use effective contraception.Check my eligibility
What is being tested?
The study tests Cariprazine's effectiveness in improving cognition (like memory and concentration) in euthymic bipolar patients compared to a placebo. It's randomized and double-blind across two Canadian sites with participants unaware of whether they're receiving the drug or placebo.See study design
What are the potential side effects?
While specific side effects aren't listed here, Cariprazine can generally cause restlessness, nausea, dizziness, fatigue among others. Since it's an atypical antipsychotic medication approved by the FDA for schizophrenia and bipolar I disorder episodes treatment.
CARPZ-01 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a woman who has been postmenopausal for at least a year or am surgically sterile.
Select...
My health has been stable for the last 4 weeks.
Select...
I have been diagnosed with Bipolar I Disorder, with or without psychosis.
Select...
I am between 19 and 65 years old.
CARPZ-01 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Improvement in cognitive performance
Improvement in functioning
Secondary outcome measures
Change in Mania
Change in depression
Improvement in Objectively Rated Daily Functioning
+4 moreCARPZ-01 Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: CariprazineActive Control1 Intervention
1.5mg of Cariprazine added to their current treatment for 6 week period
Group II: PlaceboPlacebo Group1 Intervention
Matching placebo added to their current treatment for 6 week period.
Find a Location
Who is running the clinical trial?
Jayasree BasivireddyLead Sponsor
Lakshmi N Yatham, MBBS,MRCPsycPrincipal InvestigatorUniversity of British Columbia, Department of Psychiatry, BC
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Cariprazine
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- 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.
Bipolar Disorder Patient Testimony for trial: Trial Name: NCT04771299 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
Who else is applying?
What state do they live in?
Nova Scotia
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+
What site did they apply to?
Djavad Mowfaghian Centre for Brain Heath
Why did patients apply to this trial?
I have been wanting to try this medication for a few years. I have Bipolar1 with mice manic episodes. The other meds I am on make me vomit, gain weight, tremor and tire very easily. I refuse to go on lithium. I am only 22 years old and this drug is not covered by my parents medical insurance so I am hoping if the trial goes well then we can find financial options to pay for it.
PatientReceived no prior treatments
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