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

NCT ID: NCT03230864

Last Updated: 2020-01-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 119 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-20
• Study Completion Date: 2019-02-05

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 AF35700 (10 mg/day), or continue their treatment from the prospective confirmation (PC) period.

The study consists of a Screening Period (up to 3 weeks), a single-blind PC Period (6 weeks), a Double-blind Treatment (DBT) Period (8 weeks), and a Safety Follow-up Period (6 weeks).

Patients who did not fulfil the randomization criteria for the DBT Period, were withdrawn from the study after the PC period.

Patients who fulfilled the randomization criteria for the DBT Period, continued into the DBT period and were randomized into one of the 2 treatmetn arms (1:1) with either Lu AF35700 10 mg or to continue the treatment allocated in the PC period (olanzapine or risperidone) at the dose set at the last visit of the PC period. This means that approximately half of the confirmed treatment-resistant patients were randomised back to the failed treatment in the PC period.

Data was not collected seperately for the DBT olanzapine and DBT risperidone participants, and there was no intent to compare Lu AF35700 to each drug seperately.

Conditions

Treatment-resistant Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Prospective Confirmation (PC) Period

Single (patient)-blinded treatment period with risperidone or olanzapine for 6 weeks

Group Type: EXPERIMENTAL

Risperidone

Intervention Type: DRUG

4-6 mg/day, encapsulated tablets, orally

Olanzapine

Intervention Type: DRUG

15-20 mg/day, encapsulated tablets, orally

Double-blind treatment (DBT) period, Lu AF35700 10 mg

Eligible patients from PC period (based on criteria to which investigator and patient are blinded ), will be randomly assigned (1:1) double-blind treatment in DBT period, 8 weeks

Group Type: EXPERIMENTAL

Lu AF35700

Intervention Type: DRUG

10 mg/day, encapsulated tablets, orally

DBT Period, Continued treatment from PC Period

Eligible patients from PC period (based on criteria to which investigator and patient are blinded ), will be randomly assigned (1:1) double-blind treatment in DBT period, 8 weeks. Patients in this arm will continue with the same treatment and dose as at the last visit of the PC Period

Group Type: EXPERIMENTAL

Risperidone

Intervention Type: DRUG

4-6 mg/day, encapsulated tablets, orally

Olanzapine

Intervention Type: DRUG

15-20 mg/day, encapsulated tablets, orally

Interventions

Lu AF35700

10 mg/day, encapsulated tablets, orally

Intervention Type: DRUG

Risperidone

4-6 mg/day, encapsulated tablets, orally

Intervention Type: DRUG

Olanzapine

15-20 mg/day, encapsulated tablets, orally

Intervention Type: DRUG

Eligibility 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 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 Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

H. Lundbeck A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Email contact via H.Lundbeck A/S

Role: STUDY_DIRECTOR

LundbeckClinicalTrials@Lundbeck.com

Locations

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

NHO Ryukyu Hospital

Kunigami, , Japan

Fujita Health University Hospital

Toyoake, , Japan

GUZ Lipetsk Regional psychoneurological Hospital 1

Lipetsk, , Russia

Lipetsk Regional Psychoneurological Hospital

Lipetsk, , Russia

City Psychiatric Hospital # 6

Saint Petersburg, , Russia

Psychoneurological Dispensary #10

Saint Petersburg, , Russia

Psychoneurological Dispensary #1

Saint Petersburg, , Russia

Samara Psychiatric Hospital

Samara, , Russia

Tomsk National Research Medical Centre of the Russian Academy of Sciences

Tomsk, , Russia

Yaroslavl Regional Clinical Psychiatric Hospital

Yaroslavl, , Russia

Sverdlovsk Regional Clinical Psychiatric Hospital

Yekaterinburg, , Russia

Royal Edinburgh Hospital

Edinburgh, , United Kingdom

The Maudsley Hospital - GB0001

London, , United Kingdom

The Maudsley Hospital

London, , United Kingdom

Manchester Mental Health & Social Care NHS Trust - GB0003

Manchester, , United Kingdom

Manchester Mental Health & Social Care NHS Trust

Manchester, , United Kingdom

Countries

United States; Bulgaria; Japan; Russia; United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

17303A

Identifier Type: -

Identifier Source: org_study_id