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Antipsychotic

Cariprazine for Bipolar Disorder

Phase 4
Waitlist Available
Led By Martin Lan, MD
Research Sponsored by New York State Psychiatric Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of bipolar I disorder and currently meet criteria for DSM5 major depressive episode
Age 18-60 years old
Must not have
Significant active physical illness, including blood dyscrasias, lymphomas, hypersplenism, endocrinopathies, renal failure, chronic obstructive lung disease, autonomic neuropathies, peripheral vascular disease, neuromuscular disorder or tardive dyskinesia. Any medical diagnoses that would be a contraindication to cariprazine treatment, including any movement disorders. Any history of a seizure disorder
Diagnosis of any other major psychiatric disorders such as schizoaffective disorder, current psychotic depression
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial
No Placebo-Only Group

Summary

This trial will use cariprazine (Vraylar) to treat individuals with bipolar depression who are not currently on medication. Researchers will use brain scans to understand how the medication affects the brain. The goal is to improve treatment options for those who do not respond well to current medications.

Who is the study for?
This trial is for adults aged 18-60 with bipolar I disorder and current major depressive episode, scoring at least 16 on the Hamilton Depression Rating Scale. They must be willing to use birth control if applicable, tolerate medication washout, and can continue certain mood stabilizers. Excluded are those with head trauma affecting cognition, metal implants incompatible with MRI, excessive radiation exposure, claustrophobia preventing scans, weight over 350 lbs., failed or intolerable past cariprazine treatment.
What is being tested?
The study tests cariprazine (Vraylar) in treating bipolar depression while examining its effect on D3 dopamine receptors using PET brain imaging. Participants will undergo a medication regimen followed by brain scans before and during treatment to understand how the drug interacts with specific brain receptors.
What are the potential side effects?
While not explicitly listed in the provided information, common side effects of antipsychotics like cariprazine may include restlessness, tremors, sleepiness or insomnia; digestive issues such as nausea or constipation; potential weight gain; and sometimes more serious conditions like movement disorders.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have bipolar I disorder and am currently experiencing a major depressive episode.
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I am between 18 and 60 years old.
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I am experiencing severe depression, as measured by a specific depression scale.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any major ongoing illnesses or conditions that would interfere with the treatment.
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I have not been diagnosed with major psychiatric disorders like schizoaffective disorder or current psychotic depression.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
MADRS

Side effects data

From 2011 Phase 3 trial • 497 Patients • NCT01058668
17%
Akathisia
11%
Headache
10%
Nausea
10%
Extrapyramidal disorder
10%
Insomnia
9%
Vomiting
9%
Restlessness
5%
Constipation
5%
Dizziness
4%
Dyspepsia
2%
Mania
2%
Diarrhoea
2%
Tremor
1%
Endometrial cancer
1%
Hospitalisation
1%
Aggression
1%
Bipolar disorder
1%
Pulmonary embolism
1%
Bipolar I disorder
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Cariprazine (3-6 mg/Day)
Cariprazine (6-12 mg/Day)

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Cariprazine 3 mgExperimental Treatment1 Intervention
Participants will receive 3 mg daily of cariprazine (Vraylar) for six weeks
Group II: Cariprazine 1.5 mgExperimental Treatment1 Intervention
Participants will receive 1.5 mg daily of cariprazine (Vraylar) for six weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cariprazine
2010
Completed Phase 3
~11050

Find a Location

Who is running the clinical trial?

New York State Psychiatric InstituteLead Sponsor
479 Previous Clinical Trials
153,822 Total Patients Enrolled
Martin Lan, MDPrincipal InvestigatorColumbia University

Media Library

Cariprazine (Antipsychotic) Clinical Trial Eligibility Overview. Trial Name: NCT05060549 — Phase 4
Depression, Bipolar Disorder Research Study Groups: Cariprazine 1.5 mg, Cariprazine 3 mg
Depression, Bipolar Disorder Clinical Trial 2023: Cariprazine Highlights & Side Effects. Trial Name: NCT05060549 — Phase 4
Cariprazine (Antipsychotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05060549 — Phase 4
~5 spots leftby Mar 2026
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