Efficacy of Lu AF35700 in Patients With Early-in-disease or Late-in-disease Treatment-resistant Schizophrenia
Condition: Treatment-resistant Schizophrenia
MeSH terms: Schizophrenia; Schizophrenia, Treatment-Resistant
Intervention: Lu AF35700; Risperidone; Olanzapine
Intervention description: 10 mg/day, encapsulated tablets, orally; 4-6 mg/day, encapsulated tablets, orally; 15-20 mg/day, encapsulated tablets, orally
Intervention MeSH terms: Olanzapine; Risperidone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 119.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Treatment-resistant schizophrenia; Lu AF35700

Summary:

      This study evaluates the efficacy of 10 mg/day Lu AF35700 on symptoms of schizophrenia in
      patients with early-in-disease (ED) or late-in-disease (LD) treatment-resistant schizophrenia
      (TRS)
    

Eligibility criteria:

        Inclusion Criteria:

          -  The patient has schizophrenia, diagnosed according to DSM-5(TM). (Diagnostic and
             Statistical Manual of Mental Disorders) and confirmed by the Mini International
             Neuropsychiatric Interview for Schizophrenia and Psychotic Disorders (MINI-Schz).

          -  The patient is receiving treatment with a psychiatrist in either an inpatient or
             outpatient facility.

          -  The patient has been treated with adequate dose(s) of antipsychotic drug treatment for
             at least 2 weeks prior to the Screening Visit.

          -  The patient has failed to show an adequate response in the level of psychotic symptoms
             during at least one documented treatment trial with an adequate dose of an
             antipsychotic drug prescribed for an adequate time (at least lasting for 6 weeks)
             within 2 years prior to the Screening Visit. The failure to respond to the current
             antipsychotic drug treatment trial may be considered a retrospective failed treatment,
             if the patient has been treated for 6 weeks with adequate dose(s) of antipsychotic
             drug(s).

          -  The patient has a PANSS total score of ≥80 (on 1-7 scale) and a score of ≥4 (≥
             "Moderate" on 1-7 scale) on at least 2 of the following PANSS items at the Screening
             and at Baseline 1 [Week 0] Visits: P2 - Conceptual disorganization, P3 - Hallucinatory
             behavior, P6 - Suspiciousness/persecution, G9 - Unusual thought content; AND the
             patient has a CGI-S score of ≥4 (≥ "Moderately ill") at the Screening and at Baseline
             1 (Week 0) Visits.

        Exclusion Criteria:

          -  The patient has any current primary psychiatric disorder other than schizophrenia, as
             assessed using the MINI-Schz.

          -  The patient suffers from mental retardation, organic mental disorders, or mental
             disorders due to a general medical condition (DSM-5™ criteria).

          -  The patient is experiencing an acute exacerbation of his/her psychotic symptoms.

          -  The patient has been treated with, AND is resistant to, clozapine according to the
             investigator's judgement.