Effect of Lu AF35700 in Patients With Treatment-resistant Schizophrenia

• Status: Completed
• Trial end date: 2018-10-08
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the efficacy of 10 and 20 mg/day of Lu AF35700 on schizophrenia symptoms in patients with treatment-resistant schizophrenia (TRS)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: H. Lundbeck A/S
• Treatments: Olanzapine; Risperidone

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

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

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

• The patient has failed to show an adequate response in the level of psychotic symptoms despite at least one documented treatment trial with an adequate dose of an antipsychotic 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 antipsychotic treatment trial may be considered a retrospective failed treatment, if the patient was treated 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 the following 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 as assessed 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