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NCT01810380 · ClinicalTrials.gov registry record · Phase 3

Brexpiprazole in Patients With Acute Schizophrenia

A Phase 3 study, sponsored by H. Lundbeck A/S.

Completed
Registry status
Phase 3
Development phase
468
Enrollment target

NCT01810380: Completed Phase 3 study, sponsored by H. Lundbeck A/S.

NCT01810380 is a Phase 3 study that has completed, run by H. Lundbeck A/S. The registered enrollment target is 468 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (39% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01810380, a Phase 3 study, has completed, sponsored by H. Lundbeck A/S.

COMPLETED
Registry status
Phase 3
Development phase
468 participants
Enrollment target

Study Summary

To determine the efficacy and safety of brexpiprazole for the treatment of adults experiencing an acute episode of schizophrenia.

Primary Outcome

The Positive and Negative Syndrome Scale (PANSS) is a 30-item scale for assessing the symptoms of schizophrenia. For each PANSS item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS total score (30 items) ranged from 30 to 210 with a higher score indicating greater severity of symptoms.

Interventions

  • DRUG Placebo
  • DRUG Brexpiprazole
  • DRUG Quetiapine extended release

Trial Details

FieldValue
Enrollment Target 468 participants
Start Date 2013-03
Est. Completion 2014-12
Phase Phase 3
H. Lundbeck A/S

72 total trials

What the finished NCT01810380 record still lists

NCT01810380 is an interventional study that assigns participants to a tested intervention. The registered 468 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (39% lower).

The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.

NCT01810380 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01810380 about?

NCT01810380 is a clinical study titled "Brexpiprazole in Patients With Acute Schizophrenia". To determine the efficacy and safety of brexpiprazole for the treatment of adults experiencing an acute episode of schizophrenia.

What is the current status of trial NCT01810380?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 468 participants. The study started on 2013-03. Estimated completion is 2014-12.

What interventions are being tested in trial NCT01810380?

The interventions under investigation include: Placebo (DRUG), Brexpiprazole (DRUG), Quetiapine extended release (DRUG).

Who is sponsoring clinical trial NCT01810380?

This trial is sponsored by H. Lundbeck A/S, which has 72 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01810380's enrollment target sits among peer trials

468 816th of 2000 higher than 1,185 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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 NCT01810380, the US trial registry maintained by the National Library of Medicine. NCT01810380 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.