Dopamine D3 Receptor Occupancy in Bipolar Depression

Part of paid clinical trials in New York, New York.

Sponsor
New York State Psychiatric Institute
Study ID
NCT05060549
Phase
PHASE4
Status
Withdrawn

Conditions

  • Bipolar Depression

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Cariprazine — DRUG
    Participants will receive 6 weeks of cariprazine treatment

Study Details

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.

Key Dates

Start date
Jan 6, 2026
Status verified
Apr 2026
Primary completion
May 1, 2027
Completion
May 1, 2027

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Cariprazine 1.5 mg
    Participants will receive 1.5 mg daily of cariprazine (Vraylar) for six weeks
  • Experimental: Cariprazine 3 mg
    Participants will receive 3 mg daily of cariprazine (Vraylar) for six weeks

Primary Outcome Measure

MADRS [ Time Frame: 6 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Columbia University Medical CenterNew YorkNew York10032-

Find similar trials in New York, NY

By research site
Columbia University Medical Center· New York, NY

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