Bipolar DepressionPhase 4NCT05060549
Dopamine D3 Receptor Occupancy in Bipolar Depression
A Phase 4 study testing Cariprazine in people with Bipolar Depression, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
Bipolar disorder is a common condition that can cause significant disability and risk for suicide. Second generation antipsychotic medications can be used to treat depression in bipolar disorder, yet we do not know how they work. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Bipolar Depression
- What is being tested?
- Cariprazine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2026to 1 May 2027
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Capacity to provide consent, and informed consent provided
- Diagnosis of bipolar I disorder and currently meet criteria for DSM5 major depressive episode
- Depression at enrollment of sufficient severity to score at least 16 on the first 17 items of the Hamilton Depression Rating Scale when including the atypical depression items addendum
- Age 18-60 years old
- Patients who are on antidepressant (SSRI, SNRI or bupropion) or antipsychotic medications at presentation will be included if they have failed that regimen, as defined as not achieving at least partial remission after an adequate dose of medications for at least four weeks. Fluoxetine will not be allowed due to its long half-life. Patients will be able to continue to take other mood stabilizer medications (lamotrigine, lithium, valproate, carbamazepine or oxcarbazepine) if they had not made changes to the dose of those medications within eight weeks of signing consent. Benzodiazepines and hypnotics are allowed throughout the study. If taking stimulant medications, they must be willing not to take these during the study.
- Females of child-bearing potential must be willing to use an acceptable method of birth control throughout the study; abstinence if it does not require changes to usual behavior, birth control pill, male condom, IUD, dep- provera, norplant, male sterilization or female sterilization are acceptable.
- Participant is likely to tolerate medication washout if indicated
Who cannot join
- Diagnosis of any other major psychiatric disorders such as schizoaffective disorder, current psychotic depression. Any recent drug or alcohol use disorder; within 3 months before the study unless mild. Participant meets DSM5 criteria for manic episode at the time of screening, or has YMRS > 12.
- Previous failed trial of cariprazine, defined by at least six weeks of treatment at the dose of 1.5 mg per day or more. Experienced intolerable side effects of cariprazine in the past. Taking any medications that are either contraindicated or that have clinically significant drug-drug interactions (such as strong CYP3A4 inducers) with cariprazine, unless there is a plan to stop these as part of the washout.
- History of clinical deterioration when any of the medications that the participant is taking at presentation have been discontinued in the past if they will be discontinued as part of the washout.
- First-degree family history of schizophrenia if the participant is less than 33 years old.
- 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.
- Actively suicidal, as defined by expressive ideation with a plan and intent for suicide, or developing suicidal ideation that requires immediate medical or treatment intervention.
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- Active lactation
- Electroconvulsive therapy within the past 6 months
- Participants who endorse a history of prior head trauma and score 1.5 standard deviations below the mean of Trailmaking A \& B test
- Metal implants, cardiac pacemaker, metal prostheses, metal orthodontic appliances or shrapnel in the body unless there is confirmation that the substance is MRI compatible
- Current, past or anticipated exposure to radiation, including:
- Having been badged for radiation exposure in the workplace B. Participation in nuclear medicine protocols in the past year. However, participants will be eligible if the injected dose and dosimetry of the radiotracer used are known and the cumulative annual exposure of the previous study and this study is lower than the annual limit for research participants defined by FDA (21 CFR 361.1)
- History of claustrophobia that would prevent participation in imaging scans.
- Inadequate understanding of English
- Weight >350 lbs or inability to fit into the MRI scanner
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
Official title: Dopamine D3 Receptor Occupancy in Bipolar Depression by Cariprazine (Vraylar): Evaluating Its Antidepressant Benefit
Bipolar disorder is a common condition that can cause significant disability and risk for suicide. Second generation antipsychotic medications can be used to treat depression in bipolar disorder, yet we do not know how they work. Here, we will use a recently approved medication, cariprazine (Vraylar), to treat participants with bipolar depression. They will have brain imaging with PET scans before and during treatment to understand how the medication may be working. Particularly, we will look at the role of the D3 dopamine receptor.
Read the detailed description
Bipolar disorder is a common and disabling condition with a high rate of suicide. The depressed phase of the disorder accounts for most of the morbidity and mortality. Only four medications are FDA approved to treat bipolar depression. They all include a second generation antipsychotic (SGA), yet the antidepressant mechanism of SGA's is unknown. Not all bipolar patients respond to these treatments, and they can have problematic side effects. There is therefore a great need to understand these medications' antidepressant mechanism of action in order to design more effective treatment options.
This will be an exploratory occupancy study with cariprazine (Vraylar) in unmedicated participants with bipolar depression (n=8). Participants will have [11C]-(+)-PHNO scans before treatment starts, after three weeks of cariprazine, and after six weeks. Participants will be randomized to two dose groups, 1.5 mg daily (n=4) and 3 mg daily (n=4). These are typical doses of the medication for bipolar depression. Serum levels of cariprazine will be measured at each PET scan.
- Conditions
- Bipolar Depression
- Being tested
- Cariprazine
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CariprazineDrug
Also called Vraylar
Participants will receive 6 weeks of cariprazine treatment
| Study group | Role | What they receive |
|---|---|---|
| Cariprazine 1.5 mg | Experimental | Participants will receive 1.5 mg daily of cariprazine (Vraylar) for six weeks Receives: Drug: Cariprazine |
| Cariprazine 3 mg | Experimental | Participants will receive 3 mg daily of cariprazine (Vraylar) for six weeks Receives: Drug: Cariprazine |
What is being measured
The primary outcome is the main question the study is designed to answer.
MADRS
Montgomery Asberg Depression Rating Scale; Minimum value 0, Maximum 60; higher values indicate greater depression severity
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2021
- Study start6 Jan 2026 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2027 (estimated)
Why it stopped: Funding decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Lan, New York State Psychiatric Institute
- Investigators
- Martin Lan, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05060549
- Sponsor's protocol ID
- 8079
- Status last verified
- Apr 2026
- First submitted
- 22 Sep 2021
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dopamine D3 Receptor Occupancy in Bipolar Depression by Cariprazine (Vraylar): Evaluating Its Antidepressant Benefit
- ClinicalTrials.gov ID
- NCT05060549
- Acronym / sponsor ID
- 8079
- Conditions
- Bipolar Depression
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Study start
- 6 Jan 2026 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 29 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Bipolar disorder is a common condition that can cause significant disability and risk for suicide. Second generation antipsychotic medications can be used to treat depression in bipolar disorder, yet we do not know how they work. Here, we will use a recently approved medication, cariprazine (Vraylar), to treat participants with bipolar depression. They will have brain imaging with PET scans before and during treatment to understand how the medication may be working. Particularly, we will look at the role of the D3 dopamine receptor.
Detailed description
Bipolar disorder is a common and disabling condition with a high rate of suicide. The depressed phase of the disorder accounts for most of the morbidity and mortality. Only four medications are FDA approved to treat bipolar depression. They all include a second generation antipsychotic (SGA), yet the antidepressant mechanism of SGA's is unknown. Not all bipolar patients respond to these treatments, and they can have problematic side effects. There is therefore a great need to understand these medications' antidepressant mechanism of action in order to design more effective treatment options.
This will be an exploratory occupancy study with cariprazine (Vraylar) in unmedicated participants with bipolar depression (n=8). Participants will have [11C]-(+)-PHNO scans before treatment starts, after three weeks of cariprazine, and after six weeks. Participants will be randomized to two dose groups, 1.5 mg daily (n=4) and 3 mg daily (n=4). These are typical doses of the medication for bipolar depression. Serum levels of cariprazine will be measured at each PET scan.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cariprazine 1.5 mg | Experimental | Drug: CariprazineParticipants will receive 1.5 mg daily of cariprazine (Vraylar) for six weeks |
| Cariprazine 3 mg | Experimental | Drug: CariprazineParticipants will receive 3 mg daily of cariprazine (Vraylar) for six weeks |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Capacity to provide consent, and informed consent provided
- Diagnosis of bipolar I disorder and currently meet criteria for DSM5 major depressive episode
- Depression at enrollment of sufficient severity to score at least 16 on the first 17 items of the Hamilton Depression Rating Scale when including the atypical depression items addendum
- Age 18-60 years old
- Patients who are on antidepressant (SSRI, SNRI or bupropion) or antipsychotic medications at presentation will be included if they have failed that regimen, as defined as not achieving at least partial remission after an adequate dose of medications for at least four weeks. Fluoxetine will not be allowed due to its long half-life. Patients will be able to continue to take other mood stabilizer medications (lamotrigine, lithium, valproate, carbamazepine or oxcarbazepine) if they had not made changes to the dose of those medications within eight weeks of signing consent. Benzodiazepines and hypnotics are allowed throughout the study. If taking stimulant medications, they must be willing not to take these during the study.
Key exclusion criteria (15 listed)
- Diagnosis of any other major psychiatric disorders such as schizoaffective disorder, current psychotic depression. Any recent drug or alcohol use disorder; within 3 months before the study unless mild. Participant meets DSM5 criteria for manic episode at the time of screening, or has YMRS > 12.
- Previous failed trial of cariprazine, defined by at least six weeks of treatment at the dose of 1.5 mg per day or more. Experienced intolerable side effects of cariprazine in the past. Taking any medications that are either contraindicated or that have clinically significant drug-drug interactions (such as strong CYP3A4 inducers) with cariprazine, unless there is a plan to stop these as part of the washout.
- History of clinical deterioration when any of the medications that the participant is taking at presentation have been discontinued in the past if they will be discontinued as part of the washout.
- First-degree family history of schizophrenia if the participant is less than 33 years old.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CariprazineAlso: VraylarParticipants will receive 6 weeks of cariprazine treatment | Drug | Cariprazine 1.5 mg, Cariprazine 3 mg |
Primary outcome
MADRS
Time frame: 6 weeks
Montgomery Asberg Depression Rating Scale; Minimum value 0, Maximum 60; higher values indicate greater depression severity
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Lan, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cariprazine in people with Bipolar Depression, run by New York State Psychiatric Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MADRS (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.