SchizophreniaPhase 2NCT03793712
Study With Lu AF11167 for the Treatment of Negative Symptoms in Patients With Schizophrenia
A Phase 2 study testing Lu AF11167 (1-2 mg/day) and Lu AF11167 (3-4 mg/day) in people with Schizophrenia, run by H. Lundbeck A/S at 53 sites in 8 countries.
Trial summary
A study to evaluate the efficacy of 2 fixed-flexible doses of Lu AF11167 on negative symptoms in patients with schizophrenia Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Lu AF11167 (1-2 mg/day) and Lu AF11167 (3-4 mg/day)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 168 participants
- Where
- 53 sitesin 8 countries
- Study dates
- 27 Dec 2018to 3 Sep 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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 or investigator and treated by the site or investigator for at least the last 6 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). Combination therapy of two antipsychotics is only allowed with the written approval of the Medical Monitor in cases where the second antipsychotic is a low-potency first generation antipsychotic drug (e.g., chlorpromazine, promazine or chlorprothixene at low doses) or quetiapine at a dose of ≤150 mg, given in the evening for sleep problems and where both can be discontinued during the washout phase without endangering the patient's safety. Both antipsychotics will be withdrawn during the washout phase and need to be discontinued before Screening Visit 2. Combination therapy of more than 2 antipsychotic medications is not allowed during the previous 6 months prior to Screening Visit 1.
- 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.Patients hospitalized during the last 6 months for social reasons only or patients who are currently hospitalized for social reasons can be included with the Medical Monitor's approval.
- 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).
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- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
53 sites in 8 countries.
53 sites in 8 countries
Bulgaria13 sites
Mental Health Center Prof. Dr. Ivan Temkov EOOD (BG0001)
Burgas
MHAT Dr. Hristo Stambolski (BG0007)
Kazanlak
State Psychiatric Hospital Lovech (BG0012)
Lovech, 5500
First Department for men with acute mental diseases-NPH Sv. Ivan Rilski (BG0010)
Novi Iskar
UMHAT Dr.Georgi Stranski EAD (BG0006)
Pleven
Dr.Svetlozar Georgiev MD, Office of Office of Ambulatory for Group Practice for Specialized Psychiartic Help ¿ PHILIPOPOLIS OOD (BG0014)
Plovdiv, 4000
State Psychiatric Hospital - Sevlievo (BG009)
Sevlievo
Medical Center INTERMEDICA (BG0003)
Sofia
DCC Mladost-M (BG0004)
Varna
DCC Mladost-M Varna OOD (BG0005)
Varna
Med Centre Medical plus (BG008)
Varna
Center for Mental Health Veliko Tarnovo (BG0013)
Veliko Tarnovo, 5000
Mental Health Center-Vratsa EOOD (BG0002)
Vratsa
Ukraine9 sites
Si Inpn Namsu (Ua0003)
Kharkiv
Si Inpn Namsu (Ua0008)
Kharkiv
Kherson Regional Psychiatric Hospital (UA0009)
Kherson
Kiev Regional Specialized Psycho-Narcological Medical Care (UA0005)
Kiev
Communal Institution Kirovograd Regional Psychiatric Hospital. Donetsk National Medical University, Chair of psychiatry, psychotherapy, narcology and medical psychology (UA0004)
Kropyvnytskyi
Railway Clinical Hospital #1, Ukr Research Institute, Social And Forensic Psychatriy And Drug Abuse (UA0007)
Kyiv
Odessa Regional Medical Centre of Mental Health (UA0006)
Odesa
Ukrainian Medical Stomatological Academy, Chair Of Psychiatry, Narcology And Medical Psychology Based On O.F. Maltsev Poltava Regional Clinical Psychiatric Hospital (UA0001)
Poltava
Vinnitsa National Medical University (UA0002)
Vinnitsa
Hungary7 sites
Nyiro Gyula Hospital - OPAI (HU0006)
Budapest
Semmelweis Egyetem-Neurologiai Klinika (HU0005)
Budapest
Bugat Pal Hospital (HU0008)
Gyöngyös
Dr Mathe es Tarsa Bt (HU0001)
Kalocsa
Somogy Megyei Kaposi Mor Oktato Korhaz (HU0003)
Kaposvár
Szabolcs-Szatmar-Bereg megyei Korhazak es Egyetemi Oktatokorhaz, Josa Andras Oktatokorhaz, Pszichiatriai es Pszichoterapias Osztaly (HU0002)
Nyíregyháza
Javorszky Odon Hospital (HU0004)
Vác
Czechia6 sites
Dr.Jan Holan MD, Office of (CZ0003)
Brno, 61500
Meditrine s.r.o. - Psychiatricka Ambulance, Lecebne Centrum (CZ0005)
Havířov, 73601
Clinline services s.r.o. (CZ0006)
Hostivice, 25301
Neuropsychiatrie HK, s.r.o. (CZ0004)
Hradec Králové, 50009
A-Shine s.r.o. (CZ0001)
Pilsen, 31200
Institute of Neuropsychiatric Care (INEP) (CZ0007)
Prague, 18600
Poland6 sites
Gabinet Lekarski Psychiatryczny Ireneusz Kaczorowski (PL0012)
Bełchatów, 97400
Wlokiennicza Med Specjalistyczna Praktyka Lekarska dr n. med. Tomasz Markowski (PL0005)
Bialystok
Med-Ars (Pl0010)
Bydgoszcz
Centrum Zdrowia Psychicznego Biomed - Jan Latala (PL0006)
Kielce
Przychodnia Syntonia Izabela Chojnowska-Cwiakala (PL0011)
Kielce
Syntonia Sp. z o.o. (PL0002)
Pruszcz Gdański
Germany5 sites
Medical Pratice For Neurology/Psychiatry (DE0003)
Berlin
Office of Dr.Kirsten Hahn (DE0002)
Berlin
Zentralinstitut fur Seelische Gesundheit (ZI)-Leitung Abteilung Molekulares Neuroimaging (DE0004)
Mannheim
Dr. Frank Kuehn MD, Office Of (DE001)
Oranienburg
Klinikum der Eberhard-Karls-Universitaet Tuebingen (DE0007)
Tübingen
Latvia5 sites
Daugavpils Psychoneurological Hospital (LV0005)
Daugavpils
Hospital Gintermuiza (LV0001)
Jelgava
Jsc Piejuras Slimnica Psychiatry Clinic (LV0003)
Liepāja
Riga Centre Of Psychiatry And Addiction Disorders (LV0002)
Riga
Sigulda Hospital Outpatient Clinic (LV0006)
Sigulda
Estonia2 sites
Marienthali Kliinik (EE0001)
Tallinn, 11315
OU Jaanson & Laane (EE0002)
Tartu
About this study
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
A study to evaluate the efficacy of 2 fixed-flexible doses of Lu AF11167 on negative symptoms in patients with schizophrenia
- Conditions
- Schizophrenia
- Being tested
- Lu AF11167 (1-2 mg/day), Lu AF11167 (3-4 mg/day), Placebo
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lu AF11167 (1-2 mg/day)Drug
Fixed-flexible oral dose, tablets. Once daily. 12 weeks.
Lu AF11167 (3-4 mg/day)Drug
Fixed-flexible oral dose, tablets. Once daily. 12 weeks.
PlaceboDrug
Placebo oral dose, tablets. Once daily. 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Lu AF11167 low dose | Experimental | Not described Receives: Drug: Lu AF11167 (1-2 mg/day) |
| Lu AF11167 high dose | Experimental | Not described Receives: Drug: Lu AF11167 (3-4 mg/day) |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Negative Symptom Scale (BNSS) total score
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.
Measured: from baseline to Week 12
Secondary outcomes (12)
Change in Personal and Social Performance (PSP) score
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.
Measured: from baseline to Week 12
Change in Positive and Negative Syndrome Scale (PANSS) total score
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
Measured: from baseline to Week 12
Change in PANSS Marder Negative Symptom Factor score: negative symptoms
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
Measured: from baseline to Week 12
Change in PANSS Negative subscale score
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
Measured: from baseline to Week 12
Change in Clinical Global Impression - Schizophrenia (CGI-SCH-S) negative symptoms score
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.
Measured: from baseline to Week 12
Clinical Global Impression - Schizophrenia (CGI-SCH-DC) negative symptoms score
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.
Measured: at Week 12
CGI-SCH-DC negative symptoms response
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
Measured: at Week 12
BNSS response
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.
Measured: at Week 12
Change in PANSS -Positive subscale score
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
Measured: from baseline to Week 12
Change in Clinical Global Impression - Schizophrenia (CGI-SCH-S) severity of illness overall severity score
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.
Measured: from baseline to Week 12
Clinical Global Impression - Schizophrenia (CGI-SCH-DC) degree of change in overall severity score
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.
Measured: at Week 12
Change in Calgary Depression Scale for Schizophrenia (CDSS) total score
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)
Measured: from baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2019
- Study start27 Dec 2018
- Primary completion20 Aug 2020
- Study completion3 Sep 2020
Why it stopped: Lack of efficacy based on interim analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by H. Lundbeck A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- H. Lundbeck A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Email contact via H. Lundbeck A/S, Study director, LundbeckClinicalTrials@Lundbeck.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03793712
- Sponsor's protocol ID
- 17972A
- Status last verified
- Sep 2020
- First submitted
- 3 Jan 2019
- Last updated
- 23 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Meyer-Lindenberg A, Nielsen J, Such P, Lemming OM, Zambori J, Buller R, der Goltz CV. A double-blind, randomized, placebo-controlled proof of concept study of the efficacy and safety of Lu AF11167 for persistent negative symptoms in people with schizophrenia. Eur Neuropsychopharmacol. 2022 Aug;61:4-14. doi: 10.1016/j.euroneuro.2022.05.009. Epub 2022 Jun 12.
PubMed 35704951
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03793712
- Acronym / sponsor ID
- 17972A
- Conditions
- Schizophrenia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of efficacy based on interim analysis
- Enrolment
- 168 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- 27 Dec 2018 (actual)
- Primary completion
- 20 Aug 2020 (actual)
- Study completion
- 3 Sep 2020 (actual)
- First posted
- 4 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study to evaluate the efficacy of 2 fixed-flexible doses of Lu AF11167 on negative symptoms in patients with schizophrenia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lu AF11167 low dose | Experimental | Drug: Lu AF11167 (1-2 mg/day) |
| Lu AF11167 high dose | Experimental | Drug: Lu AF11167 (3-4 mg/day) |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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 or investigator and treated by the site or investigator for at least the last 6 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). Combination therapy of two antipsychotics is only allowed with the written approval of the Medical Monitor in cases where the second antipsychotic is a low-potency first generation antipsychotic drug (e.g., chlorpromazine, promazine or chlorprothixene at low doses) or quetiapine at a dose of ≤150 mg, given in the evening for sleep problems and where both can be discontinued during the washout phase without endangering the patient's safety. Both antipsychotics will be withdrawn during the washout phase and need to be discontinued before Screening Visit 2. Combination therapy of more than 2 antipsychotic medications is not allowed during the previous 6 months prior to Screening Visit 1.
- 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.Patients hospitalized during the last 6 months for social reasons only or patients who are currently hospitalized for social reasons can be included with the Medical Monitor's approval.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lu AF11167 (1-2 mg/day)Fixed-flexible oral dose, tablets. Once daily. 12 weeks. | Drug | Lu AF11167 low dose |
| Lu AF11167 (3-4 mg/day)Fixed-flexible oral dose, tablets. Once daily. 12 weeks. | Drug | Lu AF11167 high dose |
| PlaceboPlacebo oral dose, tablets. Once daily. 12 weeks. | Drug | Placebo |
Primary outcome
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.
12 secondary outcomes
Change in Personal and Social Performance (PSP) score
Time frame: from baseline to Week 12
Change in Positive and Negative Syndrome Scale (PANSS) total score
Time frame: from baseline to Week 12
Change in PANSS Marder Negative Symptom Factor score: negative symptoms
Time frame: from baseline to Week 12
Change in PANSS Negative subscale score
Time frame: from baseline to Week 12
Change in Clinical Global Impression - Schizophrenia (CGI-SCH-S) negative symptoms score
Time frame: from baseline to Week 12
Clinical Global Impression - Schizophrenia (CGI-SCH-DC) negative symptoms score
Time frame: at Week 12
CGI-SCH-DC negative symptoms response
Time frame: at Week 12
BNSS response
Time frame: at Week 12
Change in PANSS -Positive subscale score
Time frame: from baseline to Week 12
Change in Clinical Global Impression - Schizophrenia (CGI-SCH-S) severity of illness overall severity score
Time frame: from baseline to Week 12
Clinical Global Impression - Schizophrenia (CGI-SCH-DC) degree of change in overall severity score
Time frame: at Week 12
Change in Calgary Depression Scale for Schizophrenia (CDSS) total score
Time frame: from baseline to Week 12
Results and safety
The study was stopped early (reason given: Lack of efficacy based on interim analysis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2020.
- Derived from this study: PubMed 35704951Meyer-Lindenberg A, Nielsen J, Such P, Lemming OM, Zambori J, Buller R, der Goltz CV. A double-blind, randomized, placebo-controlled proof of concept study of the efficacy and safety of Lu AF11167 for persistent negative symptoms in people with schizophrenia. Eur Neuropsychopharmacol. 2022 Aug;61:4-14. doi: 10.1016/j.euroneuro.2022.05.009. Epub 2022 Jun 12.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Email contact via H. Lundbeck A/S study director
LundbeckClinicalTrials@Lundbeck.com
53 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lu AF11167 (1-2 mg/day) and Lu AF11167 (3-4 mg/day) in people with Schizophrenia, run by H. Lundbeck A/S at 53 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 53 sites in Bulgaria, Ukraine, Hungary, Czechia, Poland and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Lack of efficacy based on interim analysis). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Negative Symptom Scale (BNSS) total score (time frame: from baseline to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03793712, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2020.