Flexible-dose, Long-term Safety Study of Lu AF35700 in Adult Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Lu AF35700
Intervention description: Flexible-dose of Lu AF35700, 10 or 20 mg/day, tablets, orally.
From Day 8, the daily dose can be increased to 20mg. Thereafter, the daily dose can be adjusted (decreased to 10mg or following a decrease, increased to 20mg/day)
Patients who completed the 16159A study, only, can be switched to a weekly 70 mg Lu AF35700 dosing regimen (tablets, orally, once weekly) after 8 weeks in this study
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 528.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

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

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