Treatment-resistant schizophrenia MedDRA version: 19.0 Level: LLT Classification code 10072913 Term: Treatment-resistant schizophrenia System Organ Class: 100000004873
Conditions
Interventions
Product Name: AF35700
Product Code: AF35700
Pharmaceutical Form: Tablet
INN or Proposed INN: AF35700
Current Sponsor code: AF35700
Sponsors
H. Lundbeck A/S
Eligibility
Sex/Gender
All
Inclusion 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 397 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 3
Exclusion criteria
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and tolerability of the long-term treatment with Lu AF35700;Secondary Objective: Not applicable; Primary end point(s): Safety and tolerability Based on the Safety variables (Adverse events, clinical safety laboratory tests, vital signs, weight, waist circumference and ECG ;Timepoint(s) of evaluation of this end point: From dosing to end of study (57 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Argentina, Bulgaria, Canada, Czech Republic, Estonia, Finland, Italy, Mexico, Poland, Romania, Russian Federation, Serbia, Slovakia, Spain, United States
Contacts
Public ContactLundbeckClinicalTrials@lundbeck.com
Lundbeck España S.A.
Outcome results
None listed