NCT06961968 · Vanda Pharmaceuticals
Randomized Withdrawal Study in Patients With Schizophrenia
What this study is about
The purpose of this research is to evaluate the effectiveness of dosing iloperidone long-acting injection (LAI) compared to placebo in preventing the exacerbation of symptoms in patients with schizophrenia.
View original scientific description
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.
Interventions
DRUG
iloperidone
iloperidone LAI
DRUG
placebo
matching placebo
Primary outcome measures
Time to exacerbation of symptoms
Time frame: Up to 52 weeks post-randomization
As measured by the time to first exacerbation of psychiatric symptoms
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Males or females 18 to 65 years of age (inclusive)
- Diagnosed with schizophrenia per DSM-5 criteria
- In need of ongoing psychiatric treatment
Exclusion criteria
- DSM-5 diagnosis of a psychiatric disorder other than schizophrenia that was the primary focus of treatment within the previous six months
Where
- Rogers, Arkansas
- Costa Mesa, California
- Lemon Grove, California
- Oceanside, California
- Pico Rivera, California
- San Diego, California
- Walnut Creek, California
- North Miami, Florida
- Atlanta, Georgia
- Peachtree Corners, Georgia
- Chicago, Illinois
- Flowood, Mississippi
And 10 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 12, 2026 · Source of record for eligibility and locations