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

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ClinicalTrials.gov Identifier: NCT03230864
Recruitment Status : Recruiting
First Posted : July 27, 2017
Last Update Posted : July 12, 2018
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S

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)

Condition or disease Intervention/treatment Phase
Treatment-resistant Schizophrenia Drug: Lu AF35700 Drug: Risperidone Drug: Olanzapine Phase 2

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 with risperidone or olanzapine.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 285 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : July 20, 2017
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Risperidone

Arm Intervention/treatment
Experimental: Lu AF35700 10 mg
10 mg encapsulated tablets administered orally, once daily.
Drug: Lu AF35700
10 mg/day, encapsulated tablets, orally

Experimental: Continued treatment from Period A
4-6 mg risperidone or 15-20 mg olanzapine encapsulated tablets administered orally, once daily.
Drug: Risperidone
4-6 mg/day, encapsulated tablets, orally

Drug: Olanzapine
15-20 mg/day, encapsulated tablets, orally




Primary Outcome Measures :
  1. Change in Positive and Negative Syndrome Scale (PANSS) total score [ Time Frame: Baseline 2 to Week 14 ]
    The Positive and Negative Syndrome Scale (PANSS) is a 30-item scale for assessing the symptoms of schizophrenia. For each PANSS item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS total score (30 items) ranged from 30 to 210 with a higher score indicating greater severity of symptoms.


Secondary Outcome Measures :
  1. Change in Global Clinical Impression - Severity of Illness (CGI-S) score [ Time Frame: Baseline 2 to Week 14 ]
    The Clinical Global Impression - Severity of Illness (CGI-S) provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients).

  2. Change in 16-item Negative Symptom Assessment (NSA-16 total) score [ Time Frame: Baseline 2 to Week 14 ]
    The NSA-16 is a clinician-rated scale designed to assess the presence, severity, and range of negative symptoms associated with schizophrenia. The NSA-16 consists of 16 items arranged in 5 subdomains: communication dysfunction (items 1 to 4), emotional/affective dysfunction (items 5 to 7), dysfunction in sociality (items 8 to 10), motivational/hedonic dysfunction (items 11 to 14), and reduced psychomotor activity (items 15 and 16), and a Global Negative Symptom Rating. NSA-16 items are rated on a 6-point scale from 1 (behaviour is normal) to 6 (behaviour severely reduced), and a score of 9 if the item is not-rateable. The Global Negative Symptom Rating is rated from 1 (no evidence of symptoms) to 7 (extremely severe symptoms). The 16 items are summed to yield a total score ranging from 16 to 96 and the global rating ranges from 1 to 7.

  3. Change in PANSS Negative Factor Score (Marder Negative Score) [ Time Frame: Baseline 2 to Week 14 ]
    The PANSS Negative Factor score is a subset of the PANSS assessing negative symptoms of schizophrenia. The factor consist of the seven items: blunted affect, emotional withdrawal, poor rapport, passive social withdrawal, lack of spontaneity, motor retardation, and active social avoidance which are each rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS Negative Factor score (7 items) range from 7 to 49 with a higher score indicating greater severity of symptoms.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03230864


Contacts
Contact: Email contact via H.Lundbeck A/S +4536301311 LundbeckClinicalTrials@Lundbeck.com

  Hide Study Locations
Locations
United States, California
University of California San Diego Health System Recruiting
San Diego, California, United States, 92103
United States, Georgia
Emory University Cognitive Neurology Clinic & ADRC Recruiting
Atlanta, Georgia, United States, 30329
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
United States, Massachusetts
Corrigan Mental Health Center Recruiting
Fall River, Massachusetts, United States, 02720
University Of Massachusetts Medical Center Recruiting
Worcester, Massachusetts, United States, 01605-2610
United States, Michigan
Michigan Clinical Research Institute PC Recruiting
Ann Arbor, Michigan, United States, 48108
Kalamazoo Community Mental Health and Substance Abuse Services Recruiting
Kalamazoo, Michigan, United States, 49001
United States, Missouri
PsychCare Consultants Research Recruiting
Saint Louis, Missouri, United States, 63128
United States, Nebraska
Creighton University Recruiting
Omaha, Nebraska, United States, 68131
United States, North Carolina
Carolina Behavioral Care Recruiting
Durham, North Carolina, United States, 27704
United States, Utah
Psychiatric and Behavioral Solutions Recruiting
Salt Lake City, Utah, United States, 84105
Bulgaria
SPH - Kardzhali Recruiting
Kardzhali, Bulgaria
State Psychiatric Hospital Recruiting
Novi Iskar, Bulgaria
UMHAT Recruiting
Pleven, Bulgaria
State Psychiatric Hospital Recruiting
Radnevo, Bulgaria
DCC St. Vrach and St.St. Kuzma and Damian Not yet recruiting
Sofia, Bulgaria
MHC - Sofia Recruiting
Sofia, Bulgaria
MHAT - Targovishte Recruiting
Tărgovište, Bulgaria
Japan
Takeda General Hospital - JP0009 Recruiting
Aizu-Wakamatsu, Japan
Takeda General Hospital Recruiting
Fukushima, Japan
Kohnodai Hospital Recruiting
Ichikawa, Japan
Nara Medical University Hospital Recruiting
Kashihara, Japan
University of Occupational and Environmental Health Hospital Recruiting
Kitakyushu, Japan
Sankeikai Nishigahara Hospital - JP0008 Recruiting
Kita, Japan
Sankeikai Nishigahara Hospital Recruiting
Kita, Japan
Satokai Yuge Hospital Recruiting
Kumamoto, Japan
NHO Ryukyu Hospital Recruiting
Kunigami, Japan
Fujita Health University Hospital Recruiting
Toyoake, Japan
Russian Federation
Sverdlovsk Regional Clinical Psychiatric Hospital Recruiting
Ekaterinburg, Russian Federation
Lipetsk Regional Psychoneurological Hospital Recruiting
Lipetsk, Russian Federation
City Psychiatric Hospital # 6 Recruiting
Saint Petersburg, Russian Federation
Psychoneurological Dispensary #10 Recruiting
Saint Petersburg, Russian Federation
Psychoneurological Dispensary #1 Recruiting
Saint Petersburg, Russian Federation
Samara Psychiatric Hospital Recruiting
Samara, Russian Federation
Tomsk National Research Medical Centre of the Russian Academy of Sciences Recruiting
Tomsk, Russian Federation
Yaroslavl Regional Clinical Psychiatric Hospital Recruiting
Yaroslavl, Russian Federation
United Kingdom
Royal Edinburgh Hospital Recruiting
Edinburgh, United Kingdom
The Maudsley Hospital - GB0001 Recruiting
London, United Kingdom
The Maudsley Hospital Recruiting
London, United Kingdom
Manchester Mental Health & Social Care NHS Trust - GB0003 Recruiting
Manchester, United Kingdom
Sponsors and Collaborators
H. Lundbeck A/S
Investigators
Study Director: Email contact via H.Lundbeck A/S LundbeckClinicalTrials@Lundbeck.com

Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT03230864     History of Changes
Other Study ID Numbers: 17303A
First Posted: July 27, 2017    Key Record Dates
Last Update Posted: July 12, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by H. Lundbeck A/S:
Treatment-resistant schizophrenia
Lu AF35700

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Risperidone
Olanzapine
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators