Treatment-Resistant Schizophrenia MedDRA version: 20.0 Level: LLT Classification code 10072913 Term: Treatment-resistant schizophrenia System Organ Class: 100000004873
Conditions
Interventions
Product Name: Lu AF35700
Product Code: Lu AF35700
Pharmaceutical Form: Tablet
INN or Proposed INN: Not yet assigned
Current Sponsor code
Sponsors
H. Lundbeck A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -The patient has schizophrenia, diagnosed according to DSM-5(TM). (Diagnostic and Statistical Manual of Mental Disorders) and confirmed by the Mini International Neuropsychiatric Interview for Psychotic Disorders Studies (MINI). -The patient is receiving treatment with a psychiatrist in either an inpatient or outpatient facility. -The patient has been treated with adequate dose(s) of antipsychotic drug treatment for at least 2 weeks prior to the Screening Visit. -The patient has failed to show an adequate response in the level of psychotic symptoms during at least one documented treatment trial with an adequate dose of an antipsychotic drug prescribed for an adequate time (at least lasting for 6 weeks) within 2 years prior to the Screening Visit. The failure to respond to the current antipsychotic drug treatment trial may be considered a retrospective failed treatment, if the patient has been treated for 6 weeks with adequate dose(s) of antipsychotic drug(s) -The patient has a PANSS total score of =80 (on 1-7 scale) and a score of =4 (= "Moderate" on 1-7 scale) on at least 2 of the following PANSS items at the screening and a Baseline 1 [Week 0] Visits: P2 - Conceptual disorganization, P3 - Hallucinatory behavior, P6 - Suspiciousness/persecution, G9 - Unusual thought content; AND the patient has a CGI-S score of =4 (= "Moderately ill") at the Screening and at Baseline 1 (Week 0) Visits. 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 284 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1
Exclusion criteria
Exclusion criteria: - The patient has any current primary psychiatric disorder other than schizophrenia, as assessed using the MINI. - The patient suffers from mental retardation, organic mental disorders, or mental disorders due to a general medical condition (DSM-5TM criteria). -The patient is experiencing an acute exacerbation of his/her psychotic symptoms. -The patient has been treated with, AND is resistant to, clozapine according to the investigator´s judgment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This study evaluates the efficacy of 10 mg/day Lu AF35700 on symptoms of schizophrenia in patients with early-in-disease (ED) or late-in-disease (LD) treatment-resistant schizophrenia (TRS);Secondary Objective: N/A; Primary end point(s): Change in Positive and Negative Syndrome Scale (PANSS) total score ; Timepoint(s) of evaluation of this end point: Baseline 2 to Week 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Change in Global Clinical Impression -Severity of Illness (CGI-S) score 2. Change in 16-item Negative Symptom Assessment (NSA-16 total) score 3. Change in PANSS Negative Factor Score (Marder Negative Score) ; Timepoint(s) of evaluation of this end point: Baseline 2 to Week 14 | — |
Countries
Bulgaria, Japan, Russian Federation, United Kingdom, United States
Contacts
Public ContactLundbeckClinicalTrials@lundbeck.com
H. Lundbeck A/S
Outcome results
None listed