Status:
TERMINATED
Efficacy of Lu AF35700 in Patients With Early-in-disease or Late-in-disease Treatment-resistant Schizophrenia
Lead Sponsor:
H. Lundbeck A/S
Conditions:
Treatment-resistant Schizophrenia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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)
Detailed Description
In the study, patients will receive risperidone (4-6 mg/day), or, if recently failed on risperidone, olanzapine (15-20mg/day). Later during the study, patients will be randomized to either receive Lu ...
Eligibility Criteria
Inclusion
- 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 Schizophrenia and Psychotic Disorders (MINI-Schz).
- 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 at 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.
Exclusion
- The patient has any current primary psychiatric disorder other than schizophrenia, as assessed using the MINI-Schz.
- The patient suffers from mental retardation, organic mental disorders, or mental disorders due to a general medical condition (DSM-5™ 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 judgement.
Key Trial Info
Start Date :
July 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 5 2019
Estimated Enrollment :
119 Patients enrolled
Trial Details
Trial ID
NCT03230864
Start Date
July 20 2017
End Date
February 5 2019
Last Update
January 21 2020
Active Locations (41)
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1
University of California San Diego Health System
San Diego, California, United States, 92103
2
Emory University Cognitive Neurology Clinic & ADRC
Atlanta, Georgia, United States, 30329
3
Northwestern University
Chicago, Illinois, United States, 60611
4
Corrigan Mental Health Center
Fall River, Massachusetts, United States, 02720