Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06961968 · ClinicalTrials.gov registry record · Phase 3
Randomized Withdrawal Study in Patients With Schizophrenia
A Phase 3 study of Schizophrenia, sponsored by Vanda Pharmaceuticals.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 400
- Enrollment target
- 20
- Study locations
NCT06961968: Recruiting Phase 3 study of Schizophrenia, sponsored by Vanda Pharmaceuticals.
NCT06961968 is a Phase 3 study of Schizophrenia that is actively recruiting participants, run by Vanda Pharmaceuticals. The registered enrollment target is 400 participants, above the 218-participant average among 315 other Schizophrenia trials with a reported enrollment target (83% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06961968, a Phase 3 study of Schizophrenia, is actively recruiting participants, sponsored by Vanda Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 400 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this research is to evaluate the efficacy of dosing iloperidone long-acting injection (LAI) compared to placebo in preventing the exacerbation of symptoms in patients with schizophrenia.
Primary Outcome
As measured by the time to first exacerbation of psychiatric symptoms
Conditions Studied
Interventions
- DRUG placebo
- DRUG iloperidone
Study Locations (20)
California
- Vanda Investigational Site - Costa Mesa
- Vanda Investigational Site - Lemon Grove
- Vanda Investigational Site - Oceanside
- Vanda Investigational Site - Pico Rivera
- Vanda Investigational Site - San Diego
- Vanda Investigational Site - Walnut Creek
Texas
- Vanda Investigational Site - Austin
- Vanda Investigational Site - Houston
- Vanda Investigational Site - Irving
Georgia
- Vanda Investigational Site - Atlanta
- Vanda Investigational Site - Peachtree Corners
Missouri
- Vanda Investigational Site - Saint Charles
- Vanda Investigational Site - St Louis
Arkansas
- Vanda Investigational Site - Rogers
Florida
- Vanda Investigational Site - North Miami
Illinois
- Vanda Investigational Site - Chicago
Mississippi
- Vanda Investigational Site - Flowood
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2025-05-14 |
| Est. Completion | 2027-11 |
| Phase | Phase 3 |
What NCT06961968 shows while recruiting
NCT06961968 is an interventional study that assigns participants to a tested intervention. The registered 400 participants enrollment target is mid-sized for trials with a published cap, above the 218-participant average among 315 other Schizophrenia trials with a reported enrollment target (83% higher).
The record links to 1 condition, with Schizophrenia appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.
NCT06961968 names 20 study sites across 11 states, led by California, Texas, Georgia.
Frequently Asked Questions
What is clinical trial NCT06961968 about?
NCT06961968 is a clinical study titled "Randomized Withdrawal Study in Patients With Schizophrenia". The purpose of this research is to evaluate the efficacy of dosing iloperidone long-acting injection (LAI) compared to placebo in preventing the exacerbation of symptoms in patients with schizophrenia.
What is the current status of trial NCT06961968?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 400 participants. The study started on 2025-05-14. Estimated completion is 2027-11.
What conditions does trial NCT06961968 study?
This clinical trial studies the following conditions: Schizophrenia.
What interventions are being tested in trial NCT06961968?
The interventions under investigation include: placebo (DRUG), iloperidone (DRUG).
Who is sponsoring clinical trial NCT06961968?
This trial is sponsored by Vanda Pharmaceuticals, which has 68 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06961968 being conducted?
This trial has 20 study locations across Arkansas, California, Florida, Georgia, Illinois. 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 NCT06961968's enrollment target sits among peer trials
400 43rd of 315 higher than 271 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
-
NBI-1117568-SCZ3032: Long-Term Evaluation of NBI-1117568 in Adults With Schizophrenia
RECRUITING · Phase 3
-
NBI-1117568-SCZ3030: Evaluation of NBI-1117568 in Inpatient Adults With Schizophrenia
RECRUITING · Phase 3
-
A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Schizophrenia in Adolescents (EMERGENT TEEN)
RECRUITING · Phase 3
-
Efficacy and Safety of Cariprazine in the Treatment of Adolescent Participants (13 to 17 Years of Age) With Schizophrenia
RECRUITING · Phase 3
-
Safety and Efficacy of Brilaroxazine (RP5063) in Schizophrenia
RECRUITING · Phase 3
-
A Trial of the Efficacy and Safety of SEP-363856 in Acutely Psychotic Participants With Schizophrenia
RECRUITING · Phase 3
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
- NCT01665326 · 400 participants
Determination of CRIM Status and Longitudinal Follow-up of Individuals With Pompe Disease
- NCT02108054 · 400 participants · NA
Behavioral and Functional Task Development, Implementation, and Testing
- NCT02216500 · 400 participants · NA
Ketogenic Therapy Effects on Electrical and Metabolic Abnormalities in Epilepsy
- NCT02250352 · 400 participants
Core Biopsies for Establishing a Breast Tumor Tissue Repository
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