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NCT05648591 · ClinicalTrials.gov registry record · Phase 4

Safety and Tolerability of Open-Labeled Iloperidone in Adolescents

A Phase 4 study of Schizophrenia and Bipolar I Disorder, sponsored by Vanda Pharmaceuticals.

Recruiting
Registry status
Phase 4
Development phase
100
Enrollment target
9
Study locations

NCT05648591 is a Phase 4 study of Schizophrenia and Bipolar I Disorder that is actively recruiting participants, run by Vanda Pharmaceuticals. The registered enrollment target is 100 participants, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (54% lower). The trial reports 9 study locations across 5 states.

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The verdict

NCT05648591, a Phase 4 study of Schizophrenia and Bipolar I Disorder, is actively recruiting participants, sponsored by Vanda Pharmaceuticals.

RECRUITING
Registry status
Phase 4
Development phase
100 participants
Enrollment target
9
Study locations

Study Summary

To evaluate the safety and tolerability of iloperidone in adolescent patients with schizophrenia or bipolar I disorder for up to 52 weeks of treatment.

Interventions

  • DRUG Iloperidone

Study Locations (9)

Georgia

  • Vanda Investigational Site - Atlanta
  • Vanda Investigational Site - Atlanta
  • Vanda Investigational Site - Decatur

Ohio

  • Vanda Investigational Site - Cincinnati
  • Vanda Investigational Site - Garfield Heights
  • Vanda Investigational Site - Westlake

Arkansas

  • Vanda Investigational Site - Little Rock

Colorado

  • Vanda Investigational Site - Denver

Washington

  • Vanda Investigational Site - Everett

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2023-05-24
Est. Completion 2026-11-30
Phase Phase 4

Sponsor

Vanda Pharmaceuticals

68 total trials

What the Registry Record Tells You About NCT05648591

The ClinicalTrials.gov registry entry for NCT05648591 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (54% lower). The listed sponsor is Vanda Pharmaceuticals, which has 68 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Schizophrenia appearing as the primary indexed condition, and to 1 intervention - of which Iloperidone is the first listed.

NCT05648591 reports 9 study locations spanning 5 distinct geographic areas - top geographies include Georgia, Ohio, Arkansas.

Frequently Asked Questions

What is clinical trial NCT05648591 about?

NCT05648591 is a clinical study titled "Safety and Tolerability of Open-Labeled Iloperidone in Adolescents". To evaluate the safety and tolerability of iloperidone in adolescent patients with schizophrenia or bipolar I disorder for up to 52 weeks of treatment.

What is the current status of trial NCT05648591?

This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 100 participants. The study started on 2023-05-24. Estimated completion is 2026-11-30.

What conditions does trial NCT05648591 study?

This clinical trial studies the following conditions: Schizophrenia, Bipolar I Disorder.

What interventions are being tested in trial NCT05648591?

The interventions under investigation include: Iloperidone (DRUG).

Who is sponsoring clinical trial NCT05648591?

This trial is sponsored by Vanda Pharmaceuticals, which has 68 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05648591 being conducted?

This trial has 9 study locations across Arkansas, Colorado, Georgia, Ohio, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.