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Safety and Tolerability of Open-Labeled Iloperidone in Adolescents

Name: Safety and Tolerability of Open-Labeled Iloperidone in Adolescents — clinical trial record (NCT05648591)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

StatusRecruiting

PhasePhase 4

SponsorVanda Pharmaceuticals

Started2023-05-24

View on ClinicalTrials.gov ↗

Trial flagged as At Risk

Primary completion moved at least 33 months later Mar 31, 2026 → Dec 31, 2028

See other at-risk trials from Vanda Pharmaceuticals

Amendment history

2026-10-02

Primary completion pushed: 2026-03-31 → 2028-12-31

Completion pushed: 2026-11-30 → 2028-12-31

2025-02-27

Study Status, Conditions, Contacts/Locations v3

Primary completion date2024-09→2026-03-31

Completion date2024-09→2026-11-30

Study sites11→9

2024-03-19

Study Status, Contacts/Locations v2

Study sites2→11

2023-06-27

Study Status, Contacts/Locations v1

Start dateestimated 2022-12→confirmed 2023-05-24

Study sites1→2

2022-12-05

Original filing

Vanda Pharmaceuticals

23 trials monitored

See 3 trials at risk

Schizophrenia

675 trials monitored

See 32 trials at risk

Bipolar Disorder

384 trials monitored

See 22 trials at risk

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

Trial Details

NCT Number	NCT05648591
Lead Sponsor	Vanda Pharmaceuticals
Conditions	Schizophrenia, Bipolar I Disorder
Enrollment	100 participants
Start Date	2023-05-24
Primary Completion	2028-12-31 (estimated)
Study Completion	2028-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-10-01