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NCT03902613 · ClinicalTrials.gov registry record · Phase 4

18F-DOPA PET to Elucidate the Antidepressant Mechanism of Lurasidone in Bipolar Disorder

A Phase 4 study, sponsored by New York State Psychiatric Institute.

Completed
Registry status
Phase 4
Development phase
1
Enrollment target

NCT03902613: Completed Phase 4 study, sponsored by New York State Psychiatric Institute.

NCT03902613 is a Phase 4 study that has completed, run by New York State Psychiatric Institute. The registered enrollment target is 1 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03902613, a Phase 4 study, has completed, sponsored by New York State Psychiatric Institute.

COMPLETED
Registry status
Phase 4
Development phase
1 participants
Enrollment target

Study Summary

The goal of this project is to understand what causes bipolar disorder and how medications treat bipolar depression. Particularly, the project focuses on the importance of dopamine signaling in the process. Participants will have two different brain scans (MRI and PET scan). They will also have treatment for your depression with an FDA approved medication, lurasidone (Latuda). The study is funded by the Columbia University Irving Institute to improve the treatment of bipolar disorder.

Primary Outcome

Measures severity of depression symptoms; Scale from 0 to 54; higher numbers mean greater depression severity, so a decrease in score is a better outcome.

Interventions

  • DRUG Lurasidone

Trial Details

FieldValue
Enrollment Target 1 participants
Start Date 2019-02-07
Est. Completion 2019-08-01
Phase Phase 4

What the finished NCT03902613 record still lists

NCT03902613 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (100% lower).

The record links to 0 conditions, and to 1 intervention - of which Lurasidone is the first listed.

NCT03902613 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03902613 about?

NCT03902613 is a clinical study titled "18F-DOPA PET to Elucidate the Antidepressant Mechanism of Lurasidone in Bipolar Disorder". The goal of this project is to understand what causes bipolar disorder and how medications treat bipolar depression. Particularly, the project focuses on the importance of dopamine signaling in the process. Participants will have two different brain scans (MRI and PET scan). They will also have trea...

What is the current status of trial NCT03902613?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 1 participants. The study started on 2019-02-07. Estimated completion is 2019-08-01.

What interventions are being tested in trial NCT03902613?

The interventions under investigation include: Lurasidone (DRUG).

Who is sponsoring clinical trial NCT03902613?

This trial is sponsored by New York State Psychiatric Institute, which has 364 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03902613's enrollment target sits among peer trials

1 2000th of 2000 the lowest of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03902613, the US trial registry maintained by the National Library of Medicine. NCT03902613 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.