Efficacy of Lu AF35700 in Patients With Early-in-disease or Late-in-disease Treatment-resistant Schizophrenia

Stopped early · Phase 3

Conditions studied: Treatment-resistant Schizophrenia

In brief

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)

Key facts

Study ID

NCT03230864

Run by

H. Lundbeck A/S

People needed

119

Starts

2017-07-20

Expected to finish

2019-02-05

Last updated by the study team

2020-01-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify 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.

Where it is running

• University of California San Diego Health System — San Diego, California, United States
• Emory University Cognitive Neurology Clinic & ADRC — Atlanta, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• Corrigan Mental Health Center — Fall River, Massachusetts, United States
• University Of Massachusetts Medical Center — Worcester, Massachusetts, United States
• Michigan Clinical Research Institute PC — Ann Arbor, Michigan, United States
• Kalamazoo Community Mental Health and Substance Abuse Services — Kalamazoo, Michigan, United States
• PsychCare Consultants Research — St Louis, Missouri, United States
• Creighton University — Omaha, Nebraska, United States
• Psychiatric and Behavioral Solutions — Salt Lake City, Utah, United States
• SPH - Kardzhali — Kardzhali, Bulgaria
• State Psychiatric Hospital — Novi Iskar, Bulgaria
• UMHAT — Pleven, Bulgaria
• State Psychiatric Hospital — Radnevo, Bulgaria
• DCC St. Vrach and St.St. Kuzma and Damian — Sofia, Bulgaria
• MHC - Sofia — Sofia, Bulgaria
• MHAT - Targovishte — Targovishte, Bulgaria
• Takeda General Hospital - JP0009 — Aizu-Wakamatsu, Japan
• Takeda General Hospital — Fukushima, Japan
• Kohnodai Hospital — Ichikawa, Japan
• Nara Medical University Hospital — Kashihara, Japan
• Sankeikai Nishigahara Hospital - JP0008 — Kita-ku, Japan
• University of Occupational and Environmental Health Hospital — Kitakyushu, Japan
• National Center of Neurology and Psychiatry — Kodaira, Japan
• Satokai Yuge Hospital — Kumamoto, Japan

Full record on ClinicalTrials.gov

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