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Study With Lu AF11167 for the Treatment of Negative Symptoms in Patients With Schizophrenia

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ClinicalTrials.gov Identifier: NCT03793712
Recruitment Status : Recruiting
First Posted : January 4, 2019
Last Update Posted : October 22, 2019
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S

Brief Summary:
A study to evaluate the efficacy of 2 fixed-flexible doses of Lu AF11167 on negative symptoms in patients with schizophrenia

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Lu AF11167 (1-2 mg/day) Drug: Lu AF11167 (3-4 mg/day) Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled, Fixed-flexible-dose Study of Lu AF11167 for the Treatment of Persistent Prominent Negative Symptoms in Patients With Schizophrenia
Actual Study Start Date : December 27, 2018
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: Lu AF11167 low dose Drug: Lu AF11167 (1-2 mg/day)
Fixed-flexible oral dose, tablets. Once daily. 12 weeks.

Experimental: Lu AF11167 high dose Drug: Lu AF11167 (3-4 mg/day)
Fixed-flexible oral dose, tablets. Once daily. 12 weeks.

Placebo Comparator: Placebo Drug: Placebo
Placebo oral dose, tablets. Once daily. 12 weeks.




Primary Outcome Measures :
  1. Change in Negative Symptom Scale (BNSS) total score [ Time Frame: from baseline to Week 12 ]
    The BNSS is a brief clinician rating scale, intended to measure negative symptoms. It consists of 13 items organized into 6 subscales: anhedonia, distress, asociality, avolition, blunted affect and alogia. The items score the impairment. Items 1 to 4 are rated from 0 (Normal) to 6 (Extremely severe) and items 5 to 13 are rated from 0 (No impairment) to 6 (Severe deficit). The BNSS total score is calculated by summing the 13 individual items; subscale scores are calculated by summing the individual items within each subscale. Users of the BNSS should have training in psychiatric interview techniques and have clinical experience working with patients with schizophrenia and related psychotic disorders. The BNSS total scores ranges from 0 to 78.


Secondary Outcome Measures :
  1. Change in Personal and Social Performance (PSP) score [ Time Frame: from baseline to Week 12 ]
    The PSP is a clinician-rated scale designed and validated to measure a patient's current level of social functioning. The PSP consists of 4 items: socially useful activities (including work and study), personal and social relationships, self-care, and disturbing and aggressive behaviours. The 4 items are assessed on a 6-point scale, from absent to very severe. Based on these assessments and their combination, individual scores are converted into a global score ranging from 1 to 100.

  2. Change in Positive and Negative Syndrome Scale (PANSS) total score [ Time Frame: from baseline to Week 12 ]
    The PANSS is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS includes 3 sub-scales and 30 items

  3. Change in PANSS Marder Negative Symptom Factor score: negative symptoms [ Time Frame: from baseline to Week 12 ]
    The PANSS is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS includes 3 sub-scales and 30 items

  4. Change in PANSS Negative subscale score [ Time Frame: from baseline to Week 12 ]
    The PANSS is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS includes 3 sub-scales and 30 items

  5. Change in Clinical Global Impression - Schizophrenia (CGI-SCH-S) negative symptoms score [ Time Frame: from baseline to Week 12 ]
    The CGI-SCH is a clinician-rated scale to assess global illness severity and degree of change in patients with schizophrenia. For both the global illness severity and degree of change, the CGI-SCH consists of four different groups of symptoms (positive, negative, cognitive and depressive) and the overall severity of the disorder. The CGI-SCH-S severity of illness category symptoms and overall severity are rated on a 7-point scale ranging from 1 (normal - not ill) to 7 (Among the most severely ill). For the first four ratings (positive, negative, depressive, and cognitive symptoms), the assessment should focus on the severity of symptoms only. Additionally, for 'overall severity' rating, both severity of symptoms and interference with functioning should be considered.

  6. Clinical Global Impression - Schizophrenia (CGI-SCH-DC) negative symptoms score [ Time Frame: at Week 12 ]
    The CGI-SCH is a clinician-rated scale to assess global illness severity and degree of change in patients with schizophrenia. For both the global illness severity and degree of change, the CGI-SCH consists of four different groups of symptoms (positive, negative, cognitive and depressive) and the overall severity of the disorder. In the CGI-SCH-DC degree of change category symptoms and overall severity are rated on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Each single rating (conditions of severity and degree of improvement) and overall ratings of severity and improvement are scored independently and no total score is derived.

  7. CGI-SCH-DC negative symptoms response [ Time Frame: at Week 12 ]
    The CGI-SCH is a clinician-rated scale to assess global illness severity and degree of change in patients with schizophrenia. For both the global illness severity and degree of change, the CGI-SCH consists of four different groups of symptoms (positive, negative, cognitive and depressive) and the overall severity of the disorder. In the CGI-SCH-DC degree of change category symptoms and overall severity are rated on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Each single rating (conditions of severity and degree of improvement) and overall ratings of severity and improvement are scored independently and no total score is derived. Response defined as CGI-SCH-DC negative symptoms = 1 or 2

  8. BNSS response [ Time Frame: at Week 12 ]
    The BNSS is a brief clinician rating scale, intended to measure negative symptoms. It consists of 13 items organized into 6 subscales: anhedonia, distress, asociality, avolition, blunted affect and alogia. The items score the impairment. Items 1 to 4 are rated from 0 (Normal) to 6 (Extremely severe) and items 5 to 13 are rated from 0 (No impairment) to 6 (Severe deficit). The BNSS total score is calculated by summing the 13 individual items; subscale scores are calculated by summing the individual items within each subscale. Users of the BNSS should have training in psychiatric interview techniques and have clinical experience working with patients with schizophrenia and related psychotic disorders. The BNSS total scores ranges from 0 to 78. Response criteria defined as 20,30 or 40% decrease in BNSS total score.

  9. Change in PANSS -Positive subscale score [ Time Frame: from baseline to Week 12 ]
    The PANSS is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS includes 3 sub-scales and 30 items

  10. Change in Clinical Global Impression - Schizophrenia (CGI-SCH-S) severity of illness overall severity score [ Time Frame: from baseline to Week 12 ]
    The CGI-SCH is a clinician-rated scale to assess global illness severity and degree of change in patients with schizophrenia. For both the global illness severity and degree of change, the CGI-SCH consists of four different groups of symptoms (positive, negative, cognitive and depressive) and the overall severity of the disorder. The CGI-SCH-S severity of illness category symptoms and overall severity are rated on a 7-point scale ranging from 1 (normal - not ill) to 7 (Among the most severely ill). For the first four ratings (positive, negative, depressive, and cognitive symptoms), the assessment should focus on the severity of symptoms only. Additionally, for 'overall severity' rating, both severity of symptoms and interference with functioning should be considered.

  11. Clinical Global Impression - Schizophrenia (CGI-SCH-DC) degree of change in overall severity score [ Time Frame: at Week 12 ]
    The CGI-SCH is a clinician-rated scale to assess global illness severity and degree of change in patients with schizophrenia. For both the global illness severity and degree of change, the CGI-SCH consists of four different groups of symptoms (positive, negative, cognitive and depressive) and the overall severity of the disorder. In the CGI-SCH-DC degree of change category symptoms and overall severity are rated on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Each single rating (conditions of severity and degree of improvement) and overall ratings of severity and improvement are scored independently and no total score is derived.

  12. Change in Calgary Depression Scale for Schizophrenia (CDSS) total score [ Time Frame: from baseline to Week 12 ]
    The CDSS is a 9-item clinician rated scale specifically developed for the assessment of depression in patients with schizophrenia. The items on the CDSS are all typical depressive symptoms and do not appear to overlap with the negative symptoms of schizophrenia. All items are rated on a 4-point scale from 0 (absent) to 3 (severe)



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • The patient has schizophrenia, diagnosed according to DSM-5® as confirmed by the Mini-International Neuropsychiatric Interview for Schizophrenia and Psychotic Disorders Studies (MINI-Schz).
  • The patient has been known to the site and treated by the site for at least the last 12 months prior to Screening Visit 1.
  • The patient has suffered from persistent prominent negative symptoms for the last 6 months prior to the Screening Visit 1, in the opinion of the investigator and recorded in medical records.
  • The patient has been treated for schizophrenia with stable doses of an oral antipsychotic within the approved dose range and without any dose increase during the last 6 months prior to Screening Visit 1 (dose reductions are acceptable).
  • The patient has had no psychiatric admissions/hospitalization due to a clinical deterioration during the last 6 months prior to Screening Visit 1, this excludes ambulatory visits to ask for advice from the psychiatry team.
  • The patient is in a clinically stable phase of schizophrenia and has not more than moderate severity on relevant positive symptoms, that is a score of ≤4 (moderate) out of score of 7 on each of the following PANSS items: Delusions (P1), Hallucinatory behaviour (P3), Suspiciousness / persecution (P6), Uncooperativeness (G8), Unusual thought content (G9) at Screening Visit 1, Washout Visit(s), Screening Visit 2, and Baseline Visit and a score ≤5 on Conceptual disorganization (P2).
  • The patient currently has no clinically significant acute extrapyramidal side effects (acute EPS) or tardive dyskinesia (TD) based upon the protocol-specified clinical examination.
  • The patient has prominent negative symptoms as demonstrated by a PANSS Marder Negative Symptom Factor Score (NSFS) ≥20 at Screening Visit 1, Washout Visit(s) and Screening Visit 2. NSFS is the sum of scores of the following PANSS items: Blunted affect (N1), Emotional withdrawal (N2), Poor rapport (N3), Passive/apathetic social withdrawal (N4), Lack of spontaneity & flow of conversation (N6), Motor retardation (G7) and Active social avoidance (G16).
  • The patient has a Clinical Global Impression-Schizophrenia Severity of Illness (CGI-SCH-S) overall severity score ≤4 at Screening Visit 1.
  • The patient does not currently have a diagnosis of Major Depressive Disorder or have depressive symptoms rated with a total score ≥5 on the Calgary Depression Scale for Schizophrenia (CDSS).
  • The patient has no history of violent behaviour for the last 12 months prior to Screening Visit 1.
  • The patient has a caregiver or an identified responsible person (for example, partner, family member, social worker, case worker, or nurse) considered reliable by the investigator in providing support to the patient to ensure compliance with study treatment, outpatient visits, and protocol procedures.

Exclusion criteria

  • The patient has had an acute exacerbation requiring hospitalization within the last 6 months prior to Screening Visit 1.
  • The patient has had an acute exacerbation requiring change in antipsychotic medication (with reference to drug or dose) within the last 6 months prior to Screening Visit 1.
  • The patient has a current diagnosis or a history of substance use disorder according to DSM-5® criteria within 6 months prior to Screening Visit 1 with the exception of tobacco, or mild cannabis or mild alcohol use disorder (occasional - but not weekly recreational cannabis use is acceptable). Patients with a positive drug screen test for opiates, methadone, cocaine, amphetamines [including ecstasy], barbiturates, verified by repeated testing, are excluded from the study.
  • The patient is at significant risk of harming himself/herself or others in the investigator's opinion.
  • The patient has tested positive for hepatitis A virus antibody (anti-HAV IgM), hepatitis B surface antigen (HBsAg), or hepatitis C virus antibody (anti-HCV). If the anti-HCV test result is positive, but acute/chronic infection is excluded with a negative HCV RNA test patient can be included in the study.
  • The patient has tested positive for human immunodeficiency virus (HIV).
  • The patient has a present condition that might compromise liver function (for example, alcohol abuse, hepatitis, hepatic insufficiency, cholestasis, haemachromatosis, deficit in alpha 1 antitrypsine, Wilson's Disease, autoimmune diseases, cirrhosis).
  • The patient has any other disorder for which the treatment takes priority over treatment of schizophrenia or is likely to interfere with the study treatment or impair treatment compliance.

Other in- and exclusion criteria may apply.


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): NCT03793712


Contacts
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Contact: Email contact via H. Lundbeck A/S +45 36301311 LundbeckClinicalTrials@Lundbeck.com

Locations
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Bulgaria
Mental Health Center Prof. Dr. Ivan Temkov EOOD (BG0001) Recruiting
Bourgas, Bulgaria
MHAT Dr. Hristo Stambolski (BG0007) Recruiting
Kazanlak, Bulgaria
First Department for men with acute mental diseases-NPH Sv. Ivan Rilski (BG0010) Recruiting
Novi Iskar, Bulgaria
UMHAT Dr.Georgi Stranski EAD (BG0006) Recruiting
Pleven, Bulgaria
State Psychiatric Hospital - Sevlievo (BG009) Recruiting
Sevlievo, Bulgaria
Medical Center INTERMEDICA (BG0003) Recruiting
Sofia, Bulgaria
DCC Mladost-M (BG0004) Recruiting
Varna, Bulgaria
DCC Mladost-M Varna OOD (BG0005) Recruiting
Varna, Bulgaria
Med Centre Medical plus (BG008) Recruiting
Varna, Bulgaria
Mental Health Center-Vratsa EOOD (BG0002) Recruiting
Vratsa, Bulgaria
Estonia
Marienthali Kliinik (EE0001) Recruiting
Tallinn, Estonia, 11315
OU Jaanson & Laane (EE0002) Recruiting
Tartu, Estonia
Germany
Medical Pratice For Neurology/Psychiatry (DE0003) Recruiting
Berlin, Germany
Office of Dr.Kirsten Hahn (DE0002) Recruiting
Berlin, Germany
Zentralinstitut fur Seelische Gesundheit (ZI)-Leitung Abteilung Molekulares Neuroimaging (DE0004) Recruiting
Mannheim, Germany
Dr. Frank Kuehn MD, Office Of (DE001) Recruiting
Oranienburg, Germany
Klinikum der Eberhard-Karls-Universitaet Tuebingen (DE0007) Recruiting
Tuebingen, Germany
Hungary
Nyiro Gyula Hospital - OPAI (HU0006) Recruiting
Budapest, Hungary
Semmelweis Egyetem-Neurologiai Klinika (HU0005) Recruiting
Budapest, Hungary
Dr Mathe es Tarsa Bt (HU0001) Recruiting
Kalocsa, Hungary
Somogy Megyei Kaposi Mor Oktato Korhaz (HU0003) Recruiting
Kaposvár, Hungary
Szabolcs-Szatmar-Bereg megyei Korhazak es Egyetemi Oktatokorhaz, Josa Andras Oktatokorhaz, Pszichiatriai es Pszichoterapias Osztaly (HU0002) Recruiting
Nyíregyháza, Hungary
Javorszky Odon Hospital (HU0004) Recruiting
Vác, Hungary
Latvia
Daugavpils Psychoneurological Hospital (LV0005) Recruiting
Daugavpils, Latvia
Hospital Gintermuiza (LV0001) Recruiting
Jelgava, Latvia
Jsc Piejuras Slimnica Psychiatry Clinic (LV0003) Recruiting
Liepāja, Latvia
Riga Centre Of Psychiatry And Addiction Disorders (LV0002) Recruiting
Riga, Latvia
Sigulda Hospital Outpatient Clinic (LV0006) Recruiting
Sigulda, Latvia
Ukraine
Si Inpn Namsu (Ua0003) Recruiting
Kharkiv, Ukraine
Si Inpn Namsu (Ua0008) Recruiting
Kharkiv, Ukraine
Kherson Regional Psychiatric Hospital (UA0009) Recruiting
Kherson, Ukraine
Kiev Regional Specialized Psycho-Narcological Medical Care (UA0005) Recruiting
Kiev, Ukraine
Communal Institution Kirovograd Regional Psychiatric Hospital. Donetsk National Medical University, Chair of psychiatry, psychotherapy, narcology and medical psychology (UA0004) Recruiting
Kropyvnytskyi, Ukraine
Railway Clinical Hospital #1, Ukr Research Institute, Social And Forensic Psychatriy And Drug Abuse (UA0007) Recruiting
Kyiv, Ukraine
Odessa Regional Medical Centre of Mental Health (UA0006) Recruiting
Odessa, Ukraine
Ukrainian Medical Stomatological Academy, Chair Of Psychiatry, Narcology And Medical Psychology Based On O.F. Maltsev Poltava Regional Clinical Psychiatric Hospital (UA0001) Recruiting
Poltava, Ukraine
Vinnitsa National Medical University (UA0002) Recruiting
Vinnitsa, Ukraine
Sponsors and Collaborators
H. Lundbeck A/S
Investigators
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Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@Lundbeck.com

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Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT03793712     History of Changes
Other Study ID Numbers: 17972A
First Posted: January 4, 2019    Key Record Dates
Last Update Posted: October 22, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders