NCT06961968 Randomized Withdrawal Study in Patients With Schizophrenia
| NCT ID | NCT06961968 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Vanda Pharmaceuticals |
| Condition | Schizophrenia |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2025-05-14 |
| Primary Completion | 2027-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 400 participants in total. It began in 2025-05-14 with a primary completion date of 2027-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06961968 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Schizophrenia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06961968 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 400 participants.
Is NCT06961968 currently recruiting?
Yes, NCT06961968 is actively recruiting participants. Contact the research team at clinicaltrials@vandapharma.com for enrollment information.
Where is the NCT06961968 trial being conducted?
This trial is being conducted at Rogers, United States, Costa Mesa, United States, Lemon Grove, United States, Oceanside, United States and 11 additional locations.
Who is sponsoring the NCT06961968 clinical trial?
NCT06961968 is sponsored by Vanda Pharmaceuticals. The trial plans to enroll 400 participants.
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