Summary

for people ages 18 years and up (full criteria)
at San Diego, California and other locations
study started
estimated completion:

Description

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)

Official Title

Interventional, Randomized, Double-blind, Active-controlled Study of the Efficacy of Lu AF35700 in Patients With Early-in-disease or Late-in-disease Treatment-resistant Schizophrenia

Details

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 AF35700 (10 mg/day), or continue their treatment with risperidone or olanzapine.

Keywords

Treatment-resistant Schizophrenia Lu AF35700 Schizophrenia Risperidone Olanzapine

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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.

Locations

  • University of California San Diego Health System accepting new patients
    San Diego California 92103 United States
  • Psychiatric and Behavioral Solutions accepting new patients
    Salt Lake City Utah 84105 United States
  • Creighton University accepting new patients
    Omaha Nebraska 68131 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
H. Lundbeck A/S
ID
NCT03230864
Phase
Phase 2
Study Type
Interventional
Last Updated
July 11, 2018