ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03230864
Recruitment Status : Recruiting
First Posted : July 27, 2017
Last Update Posted : October 12, 2018
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S

July 24, 2017
July 27, 2017
October 12, 2018
July 20, 2017
September 2020   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT03230864 on ClinicalTrials.gov Archive Site
  • 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).
  • 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.
  • 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.
Same as current
Not Provided
Not Provided
 
Efficacy of Lu AF35700 in Patients With Early-in-disease or Late-in-disease Treatment-resistant Schizophrenia
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
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)
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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Treatment-resistant Schizophrenia
  • Drug: Lu AF35700
    10 mg/day, encapsulated tablets, orally
  • Drug: Risperidone
    4-6 mg/day, encapsulated tablets, orally
  • Drug: Olanzapine
    15-20 mg/day, encapsulated tablets, orally
  • Experimental: Lu AF35700 10 mg
    10 mg encapsulated tablets administered orally, once daily.
    Intervention: Drug: Lu AF35700
  • Experimental: Continued treatment
    4-6 mg risperidone or 15-20 mg olanzapine encapsulated tablets administered orally, once daily.
    Interventions:
    • Drug: Risperidone
    • Drug: Olanzapine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
817
285
September 2020
September 2020   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact: Email contact via H.Lundbeck A/S +4536301311 LundbeckClinicalTrials@Lundbeck.com
Bulgaria,   Japan,   Russian Federation,   United Kingdom,   United States
 
 
NCT03230864
17303A
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
H. Lundbeck A/S
H. Lundbeck A/S
Not Provided
Study Director: Email contact via H.Lundbeck A/S LundbeckClinicalTrials@Lundbeck.com
H. Lundbeck A/S
October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP