Flexible-dose, Long-term Safety Study of Lu AF35700 in Adult Patients With Schizophrenia (Debut)
- Conditions
- Treatment-resistant schizophreniaMedDRA version: 20.0Level: LLTClassification code 10072913Term: Treatment-resistant schizophreniaSystem Organ Class: 100000004873Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2015-003284-11-SK
- Lead Sponsor
- H. Lundbeck A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 400
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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<br>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 Outcome Measures
Name Time Method Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable