Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting Phase 4 study of Schizophrenia and Bipolar I Disorder, sponsored by Vanda Pharmaceuticals.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2023-05-24 |
| Est. Completion | 2026-11-30 |
| Phase | Phase 4 |
What NCT05648591 shows while recruiting
NCT05648591 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (54% lower).
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 lists 9 locations in 5 states (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.
Learn More About Clinical Trials
Similar trials for Schizophrenia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05648591's enrollment target sits among peer trials
100 140th of 315 higher than 169 of 315 other Schizophrenia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Schizophrenia 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
-
Metabolic Effects of Adjunctive Lumateperone Treatment in Clozapine-Treated Patients With Schizophrenia
RECRUITING · Phase 4
-
A Study to Evaluate the Effectiveness of Valbenazine in Adult Participants With Tardive Dyskinesia (TD) Who Remain Symptomatic While Receiving or After Stopping a Vesicular Monoamine Transporter 2 (VMAT2) Inhibitor
RECRUITING · Phase 4
-
CLOZAPINE Response in Biotype-1
RECRUITING · Phase 4
-
Smoking Cessation With Varenicline in Schizophrenia: Antipsychotic-Induced Neurological Symptoms as Correlates
RECRUITING · Phase 4
-
Clozapine for the Prevention of Violence in Schizophrenia: a Randomized Clinical Trial
RECRUITING · Phase 4
-
Anti-Inflammatory Challenge in Schizophrenia
RECRUITING · Phase 4
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01048281 · 100 participants
Clinical & Pathological Studies of Upper Gastrointestinal Carcinoma
- NCT01161199 · 100 participants
The Use of Leukapheresis to Support HIV Pathogenesis Studies
- NCT01327690 · 100 participants · Early Phase 1
Mental Health in Veterans and Families After Group Therapies
- NCT01773278 · 100 participants · Phase 2
Cholesterol and Antioxidant Treatment in Patients With Smith-Lemli-Opitz Syndrome (SLOS)
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI