Study With Lu AF11167 for the Treatment of Negative Symptoms in Patients With Schizophrenia
- Conditions
- Schizophrenia
- Interventions
- Drug: Lu AF11167 (1-2 mg/day)Drug: Lu AF11167 (3-4 mg/day)Drug: Placebo
- Registration Number
- NCT03793712
- Lead Sponsor
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 168
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lu AF11167 low dose Lu AF11167 (1-2 mg/day) - Lu AF11167 high dose Lu AF11167 (3-4 mg/day) - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Change in Negative Symptom Scale (BNSS) total score 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
Name Time Method Change in PANSS Negative subscale score 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
CGI-SCH-DC negative symptoms response 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
Clinical Global Impression - Schizophrenia (CGI-SCH-DC) degree of change in overall severity score 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.
Change in Positive and Negative Syndrome Scale (PANSS) total score 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
Change in PANSS Marder Negative Symptom Factor score: negative symptoms 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
Clinical Global Impression - Schizophrenia (CGI-SCH-DC) negative symptoms score 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.
Change in Personal and Social Performance (PSP) score 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.
Change in Clinical Global Impression - Schizophrenia (CGI-SCH-S) negative symptoms score 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.
Change in Clinical Global Impression - Schizophrenia (CGI-SCH-S) severity of illness overall severity score 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.
BNSS response 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.
Change in PANSS -Positive subscale score 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
Change in Calgary Depression Scale for Schizophrenia (CDSS) total score 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)
Trial Locations
- Locations (53)
Sigulda Hospital Outpatient Clinic (LV0006)
🇱🇻Sigulda, Latvia
Med-Ars (Pl0010)
🇵🇱Bydgoszcz, Poland
Centrum Zdrowia Psychicznego Biomed - Jan Latala (PL0006)
🇵🇱Kielce, Poland
Wlokiennicza Med Specjalistyczna Praktyka Lekarska dr n. med. Tomasz Markowski (PL0005)
🇵🇱Białystok, Poland
Jsc Piejuras Slimnica Psychiatry Clinic (LV0003)
🇱🇻Liepāja, Latvia
Odessa Regional Medical Centre of Mental Health (UA0006)
🇺🇦Odessa, Ukraine
Si Inpn Namsu (Ua0003)
🇺🇦Kharkiv, Ukraine
Kherson Regional Psychiatric Hospital (UA0009)
🇺🇦Kherson, Ukraine
Vinnitsa National Medical University (UA0002)
🇺🇦Vinnitsa, Ukraine
Center for Mental Health Veliko Tarnovo (BG0013)
🇧🇬Veliko Tarnovo, Bulgaria
Hospital Gintermuiza (LV0001)
🇱🇻Jelgava, Latvia
Riga Centre Of Psychiatry And Addiction Disorders (LV0002)
🇱🇻Riga, Latvia
Communal Institution Kirovograd Regional Psychiatric Hospital. Donetsk National Medical University, Chair of psychiatry, psychotherapy, narcology and medical psychology (UA0004)
🇺🇦Kropyvnytskyi, Ukraine
DCC Mladost-M (BG0004)
🇧🇬Varna, Bulgaria
Gabinet Lekarski Psychiatryczny Ireneusz Kaczorowski (PL0012)
🇵🇱Bełchatów, Poland
Si Inpn Namsu (Ua0008)
🇺🇦Kharkiv, Ukraine
Ukrainian Medical Stomatological Academy, Chair Of Psychiatry, Narcology And Medical Psychology Based On O.F. Maltsev Poltava Regional Clinical Psychiatric Hospital (UA0001)
🇺🇦Poltava, Ukraine
Przychodnia Syntonia Izabela Chojnowska-Cwiakala (PL0011)
🇵🇱Kielce, Poland
Railway Clinical Hospital #1, Ukr Research Institute, Social And Forensic Psychatriy And Drug Abuse (UA0007)
🇺🇦Kyiv, Ukraine
DCC Mladost-M Varna OOD (BG0005)
🇧🇬Varna, Bulgaria
Med Centre Medical plus (BG008)
🇧🇬Varna, Bulgaria
A-Shine s.r.o. (CZ0001)
🇨🇿Plzen, Czechia
Mental Health Center Prof. Dr. Ivan Temkov EOOD (BG0001)
🇧🇬Bourgas, Bulgaria
MHAT Dr. Hristo Stambolski (BG0007)
🇧🇬Kazanlak, Bulgaria
State Psychiatric Hospital Lovech (BG0012)
🇧🇬Lovech, Bulgaria
First Department for men with acute mental diseases-NPH Sv. Ivan Rilski (BG0010)
🇧🇬Novi Iskar, Bulgaria
Dr.Svetlozar Georgiev MD, Office of Office of Ambulatory for Group Practice for Specialized Psychiartic Help ¿ PHILIPOPOLIS OOD (BG0014)
🇧🇬Plovdiv, Bulgaria
UMHAT Dr.Georgi Stranski EAD (BG0006)
🇧🇬Pleven, Bulgaria
State Psychiatric Hospital - Sevlievo (BG009)
🇧🇬Sevlievo, Bulgaria
Medical Center INTERMEDICA (BG0003)
🇧🇬Sofia, Bulgaria
Mental Health Center-Vratsa EOOD (BG0002)
🇧🇬Vratsa, Bulgaria
Meditrine s.r.o. - Psychiatricka Ambulance, Lecebne Centrum (CZ0005)
🇨🇿Havířov, Czechia
Dr.Jan Holan MD, Office of (CZ0003)
🇨🇿Brno, Czechia
Institute of Neuropsychiatric Care (INEP) (CZ0007)
🇨🇿Praha 8, Czechia
Clinline services s.r.o. (CZ0006)
🇨🇿Hostivice, Czechia
Marienthali Kliinik (EE0001)
🇪🇪Tallinn, Estonia
Medical Pratice For Neurology/Psychiatry (DE0003)
🇩🇪Berlin, Germany
OU Jaanson & Laane (EE0002)
🇪🇪Tartu, Estonia
Dr. Frank Kuehn MD, Office Of (DE001)
🇩🇪Oranienburg, Germany
Klinikum der Eberhard-Karls-Universitaet Tuebingen (DE0007)
🇩🇪Tuebingen, Germany
Zentralinstitut fur Seelische Gesundheit (ZI)-Leitung Abteilung Molekulares Neuroimaging (DE0004)
🇩🇪Mannheim, Germany
Office of Dr.Kirsten Hahn (DE0002)
🇩🇪Berlin, Germany
Nyiro Gyula Hospital - OPAI (HU0006)
🇭🇺Budapest, Hungary
Bugat Pal Hospital (HU0008)
🇭🇺Gyöngyös, Hungary
Semmelweis Egyetem-Neurologiai Klinika (HU0005)
🇭🇺Budapest, Hungary
Dr Mathe es Tarsa Bt (HU0001)
🇭🇺Kalocsa, Hungary
Somogy Megyei Kaposi Mor Oktato Korhaz (HU0003)
🇭🇺Kaposvár, Hungary
Szabolcs-Szatmar-Bereg megyei Korhazak es Egyetemi Oktatokorhaz, Josa Andras Oktatokorhaz, Pszichiatriai es Pszichoterapias Osztaly (HU0002)
🇭🇺Nyíregyháza, Hungary
Javorszky Odon Hospital (HU0004)
🇭🇺Vác, Hungary
Daugavpils Psychoneurological Hospital (LV0005)
🇱🇻Daugavpils, Latvia
Syntonia Sp. z o.o. (PL0002)
🇵🇱Pruszcz Gdański, Poland
Kiev Regional Specialized Psycho-Narcological Medical Care (UA0005)
🇺🇦Kiev, Ukraine
Neuropsychiatrie HK, s.r.o. (CZ0004)
🇨🇿Hradec Králové, Czechia