Flexible-dose, Long-term Safety Study of Lu AF35700 in Adult Patients With Schizophrenia

• Status: Completed
• Trial end date: 2019-10-10
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the safety and tolerability of the long-term treatment with Lu AF35700.

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

Details

• Lead Sponsor: H. Lundbeck A/S

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