At a glance
ClinicalIndex Comparison Record- ✓Diagnosis of schizophrenia (paranoid, disorganized, catatonic, or undifferentiated subtype)
- ✓PANSS total score ≥60 at screening and baseline
- ✓PANSS positive subscale score ≥4 in at least 2 of 5 items at screening and baseline
- ✓Acute exacerbation confirmed: current episode ≤2 months duration, dramatic/substantial change from baseline, medication change needed for new/worsened positive symptoms
- ✕Treatment-refractory schizophrenia defined as: ≥2 atypical antipsychotics at ≥600 mg/day chlorpromazine equivalent for >4 weeks each without response, OR clozapine for 12 weeks immediately preceding screening
- ✕Received ≥3 antipsychotic drugs or doses >18 mg/day haloperidol equivalent within 1 month prior to randomization
- ✕Schizoaffective disorder, residual subtype schizophrenia, schizophreniform disorder, or schizophrenia in remission
- ✕Concurrent Axis I psychiatric disorder other than schizophrenia; primary diagnosis other than schizophrenia
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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Matched to this trial by ClinicalIndexfrom reputable biotech & medical press.
A Multicenter, Randomized, Double-blind, Fixed-dose, 6-week Trial of the Efficacy and Safety of Asenapine Compared With Placebo in Subjects With an Acute Exacerbation of Schizophrenia (Phase 3)
In Brief
A Phase 3 clinical trial evaluating Asenapine 5 mg, Asenapine 10 mg, and 1 other intervention for Schizophrenia. Completed, enrolled 532 participants.
Detailed Summary
A multicenter, randomized, parallel-group, double-blind, fixed dose, 6-week trial of the efficacy and safety of asenapine compared with placebo in participants with an acute exacerbation of schizophrenia.
Study Details
Timeline
Interventions
Asenapine 5 mg fast dissolving tablets sublingually without water twice daily, in the morning (around 8 am) and in the evening (around 8 pm), on Day 1 only or for 6 weeks.
Participants receive on Day 2, 10 mg BID of fast dissolving tablets sublingually without water twice daily, in the morning (around 8 am) and in the evening (around 8 pm), for 6 weeks.
A matching placebo of asenapine sublingual tablet not containing asenapine