flexible-dose, long-term safety study of lu af35700 in adult patients with schizophrenia

Conditions: Schizophrenia

Summary: to evaluate the safety and tolerability of the long-term treatment with lu af35700.

safety study in patients with schizophrenia who have participated and completed a study investigating lu af35700 including studies 16159a and 16323a. or in patients with schizophrenia for whom a switch of antipsychotic treatment can be potentially beneficial according to the investigator's clinical judgement.

Eligibility criteria:
inclusion criteria: - for 16159a-patients * the patient has completed study 16159a. * the patient is able to read and understand the informed consent form. * the patient has signed the informed consent form specific for study 16159b. * the patient can potentially benefit from 52-week treatment with lu af35700 according to the investigator's clinical judgement. for 16323a-patients * the patient has completed the dosing period of study 16323a. * the patient is able to read and understand the informed consent form. * the patient has signed the informed consent form specific study 16159b. * the patient has a confirmed diagnosis of schizophrenia according to dsm-5™. * the patient can potentially benefit from 52-week treatment with lu af35700 according to the investigator's clinical judgement. for other patients * the patient has schizophrenia, diagnosed according to dsm-5™. * the patient is a man or woman, aged ≥18 years. * the patient has been prescribed oral antipsychotic treatment at the recommended dose range as stated in the summary of product characteristics or equivalent label for 6 weeks prior to the screening visit. * the patient has a panss total score ≥60 and ≤90 at screening and baseline visits. * the patient has a clinical global impression - severity of illness (cgi-s) score ≤4. * the patient is in need of a change in the current antipsychotic treatment and, according to the investigator's clinical judgement, the patient can potentially benefit from a switch to another treatment including, but not limited to, any of the following reasons: * lack of adequate response to his or her current antipsychotic medication; * poor tolerability to his or her current antipsychotic medication; * unwillingness of the patient to adhere to his or her current antipsychotic medication. exclusion criteria: - for 16159a-patients * the patient has been diagnosed with a primary psychiatric disorder other than schizophrenia during study 16159a. * the patient, in the opinion of the investigator, is at significant risk of suicide, or: answers "yes" to any question on the suicidal behaviour section of the columbia-suicide severity rating scale (c-ssrs), or answers "yes" to questions 4 and 5 on the suicidal ideation section of the c-ssrs for 16323a-patients * the patient has been diagnosed with a primary psychiatric disorder other than schizophrenia during study 16323a. * the patient, in the opinion of the investigator, is at significant risk of suicide, or: answers "yes" to any question on the suicidal behaviour section of the c-ssrs, or answers "yes" to questions 4 and 5 on the suicidal ideation section of the c-ssrs for other patients * the patient has any current psychiatric disorder (dsm-5™ criteria) other than schizophrenia established as the primary diagnosis. * the patient is experiencing acute exacerbation of psychotic symptoms at the screening visit, between the screening and baseline visits or at the baseline visit. * the patient is treated with clozapine at the time of the screening visit. * the patient has a substance use disorder (except nicotine) which according to the investigator's judgment may compromise the patient's ability to comply with the study procedures, or preclude the benefits of the study medication. * the patient, in the opinion of the investigator, is at significant risk of suicide, or: answers "yes" to any question on the suicidal behaviour section of the c-ssrs, or answers "yes" to questions 4 and 5 on the suicidal ideation section of the c-ssrs other protocol defined inclusion and exclusion criteria may apply