NCT05060549

Dopamine D3 Receptor Occupancy in Bipolar Depression

Dopamine D3 Receptor Occupancy in Bipolar Depression by Cariprazine (Vraylar): Evaluating Its Antidepressant Benefit

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: New York State Psychiatric Institute · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

• Bipolar Depression

Interventions

Type	Name	Description
DRUG	Cariprazine	Participants will receive 6 weeks of cariprazine treatment

Timeline

• Start date: 2026-01-06
• Primary completion: 2027-05-01
• Completion: 2027-05-01
• First posted: 2021-09-29
• Last updated: 2026-04-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study