Randomized Withdrawal Study in Patients With Schizophrenia
ConditionSchizophrenia
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorVanda Pharmaceuticals
About this trial
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
This trial does not accept healthy volunteersQualifiers
Males or females 18 to 65 years of age (inclusive)
Diagnosed with schizophrenia per DSM-5 criteria
In need of ongoing psychiatric treatment
Disqualifiers
DSM-5 diagnosis of a psychiatric disorder other than schizophrenia that was the primary focus of treatment within the previous six months
Trial design
Design model
Parallel
Treatments tested in this trial
iloperidone
Drugiloperidone LAI
placebo
Drugmatching placebo
Treatment groups
400 Participants
are divided into 2 treatment groupsGroup A: iloperidoneExperimental treatment 1 intervention
Group B: placeboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Time to exacerbation of symptoms
As measured by the time to first exacerbation of psychiatric symptoms
Time frame
Up to 52 weeks post-randomizationSponsors and contacts
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Source ClinicalTrials.gov