Dopamine D3 Receptor Occupancy in Bipolar Depression
NCT05060549 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL
Last updated 2026-04-14
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.
Conditions
Interventions
- DRUG
-
Cariprazine
Participants will receive 6 weeks of cariprazine treatment
Sponsors & Collaborators
-
New York State Psychiatric Institute
lead OTHER
Principal Investigators
-
Martin Lan, MD · Columbia University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-01-06
- Primary Completion
- 2027-05-01
- Completion
- 2027-05-01
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Observational Study of Oral Cariprazine Capsules to Assess Change in Disease Activity in Adult Participants With Bipolar I Disorder
NCT06256367 ·Status: COMPLETED
-
Assessing the Role of Cariprazine in Improving Cognition in Euthymic Bipolar Patients
NCT04771299 ·Status: TERMINATED ·Phase: PHASE3
-
Long-term Safety and Tolerability of Cariprazine for Bipolar I Disorder
NCT01059539 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Assess Change in Disease Activity and Adverse Events (AEs) With Cariprazine in the Treatment of Depressive Episodes in Pediatric Participants Participants (10 to 17 Years of Age) With Bipolar I Disorder.
NCT04777357 ·Status: RECRUITING ·Phase: PHASE3
-
Safety and Efficacy of RGH-188 (Cariprazine) in Bipolar Depression
NCT00852202 ·Status: COMPLETED ·Phase: PHASE2
-
Open-Label, Flexible-dose Study to Evaluate the Long-Term Safety and Tolerability of Cariprazine in the Treatment of Pediatric Participants With Schizophrenia, Bipolar I Disorder, or Autism Spectrum Disorder
NCT04578756 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Efficacy of Cariprazine for Mania
NCT01058096 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Assess the Safety, Tolerability and Efficacy of RG2417 in Bipolar I Depression
NCT00812058 ·Status: COMPLETED ·Phase: PHASE2
-
Prediction of Clinical Response to SSRI Treatment in Bipolar Disorder Using Serotonin 1A Receptor PET Imaging
NCT02473250 ·Status: COMPLETED ·Phase: PHASE4
-
Safety and Efficacy of Cariprazine for Bipolar I Disorder
NCT01058668 ·Status: COMPLETED ·Phase: PHASE3
-
Open-Label Observational Pilot Study to Evaluate the Pharmacokinetics of Aripiprazole in Subjects With Bipolar 1 Disorder or Schizophrenia
NCT02050854 ·Status: COMPLETED
-
To Evaluate the Effects of NMRA-335140 on Symptoms of Major Depression in Participants With Bipolar II Disorder.
NCT06429722 ·Status: COMPLETED ·Phase: PHASE2
-
Lithium Versus Cariprazine in the Acute Phase Treatment of Bipolar Depression (DUAG9)
NCT05913947 ·Status: RECRUITING ·Phase: PHASE4
-
Aripiprazole Treatment of Bipolar Depression
NCT00198198 ·Status: COMPLETED ·Phase: PHASE4
-
Ceftriaxone in the Management of Bipolar Depression
NCT00566111 ·Status: TERMINATED ·Phase: NA
-
Study of Aripiprazole in Patients With Bipolar I Disorder With a Major Depression Episode
NCT00080314 ·Status: COMPLETED ·Phase: PHASE3
-
An Assessment of Efficacy, Safety, and Pharmacokinetics of NBI-1117568 in Adults With Bipolar I Disorder With Current Mania
NCT07288320 ·Status: RECRUITING ·Phase: PHASE2
-
A Study of Aripiprazole in Patients With Bipolar I Disorder With a Major Depressive Episode
NCT00094432 ·Status: COMPLETED ·Phase: PHASE3
-
PET and MRI Brain Imaging of Bipolar Disorder
NCT01880957 ·Status: COMPLETED ·Phase: NA
-
Low-Dose Adjunctive Aripiprazole in the Treatment of Bipolar Depression: Double-Blind Placebo-Controlled Pilot Study
NCT01520350 ·Status: TERMINATED ·Phase: PHASE3
-
Double-blind, Placebo-Controlled Divalproex Sodium ER in Bipolar I or Bipolar II Depression
NCT00194116 ·Status: COMPLETED ·Phase: PHASE3
-
A Single Blind Study of Cranial Electrical Stimulation in Bipolar II Disorder
NCT01909011 ·Status: COMPLETED ·Phase: NA
-
Study of Oral ABBV-932 to Assess Adverse Events and Change in Disease Activity in Adult Participants With Bipolar I or II Disorder
NCT06605599 ·Status: COMPLETED ·Phase: PHASE2
-
Natural History of Depression, Bipolar Disorder and Suicide Risk
NCT06462196 ·Status: RECRUITING
-
18F-DOPA PET to Elucidate the Antidepressant Mechanism of Lurasidone in Bipolar Disorder
NCT03902613 ·Status: COMPLETED ·Phase: PHASE4