Effect of Lu AF35700 in Patients With Treatment-resistant Schizophrenia

Inclusion Criteria:

• The patient has schizophrenia, diagnosed according to DSM-5(TM) (Diagnostic andStatistical Manual of Mental Disorders) and confirmed by the Mini InternationalNeuropsychiatric Interview for Schizophrenia and Psychotic Disorders

• The patient is either an inpatient at a psychiatric setting or outpatient consulting apsychiatrist.

• Patients should be treated with adequate dose(s) and agent(s) of antipsychotictreatment for at least 2 weeks prior to Screening

• The patient has failed to show an adequate response in the level of psychotic symptomsdespite at least one documented treatment trial with an adequate dose of anantipsychotic agent prescribed for an adequate time (at least lasting for 6 weeks)during 2 years prior to Screening. The failure to respond to the current antipsychotictreatment trial may be considered a retrospective failed treatment, if the patient wastreated for 6 weeks with adequate dose(s) and agent(s)

• The patient has a PANSS total score of ≥80 and a score of ≥4 on at least 2 of thefollowing PANSS items (at Screening and at the first visit of Period A)

• The patient has a CGI-S score of ≥4 at Screening and at the first visit of Period A

Exclusion Criteria:

• The patient has any current primary psychiatric disorder other than schizophrenia asassessed by the Mini International Neuropsychiatric Interview (MINI)

• The patient is experiencing an acute exacerbation of his/her psychotic symptoms

• The patient has not responded to treatment with clozapine Other protocol defined inclusion and exclusion criteria may apply