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

NCT ID: NCT03793712

Last Updated: 2020-09-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 168 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-27
• Study Completion Date: 2020-09-03

Brief Summary

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

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Lu AF11167 low dose

Group Type: EXPERIMENTAL

Lu AF11167 (1-2 mg/day)

Intervention Type: DRUG

Fixed-flexible oral dose, tablets. Once daily. 12 weeks.

Lu AF11167 high dose

Group Type: EXPERIMENTAL

Lu AF11167 (3-4 mg/day)

Intervention Type: DRUG

Fixed-flexible oral dose, tablets. Once daily. 12 weeks.

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo oral dose, tablets. Once daily. 12 weeks.

Interventions

Lu AF11167 (1-2 mg/day)

Fixed-flexible oral dose, tablets. Once daily. 12 weeks.

Intervention Type: DRUG

Lu AF11167 (3-4 mg/day)

Fixed-flexible oral dose, tablets. Once daily. 12 weeks.

Intervention Type: DRUG

Placebo

Placebo oral dose, tablets. Once daily. 12 weeks.

Intervention Type: DRUG

Eligibility 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 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).
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

H. Lundbeck A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Email contact via H. Lundbeck A/S

Role: STUDY_DIRECTOR

LundbeckClinicalTrials@Lundbeck.com

Locations

Mental Health Center Prof. Dr. Ivan Temkov EOOD (BG0001)

Burgas, , 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

UMHAT Dr.Georgi Stranski EAD (BG0006)

Pleven, , Bulgaria

Dr.Svetlozar Georgiev MD, Office of Office of Ambulatory for Group Practice for Specialized Psychiartic Help ¿ PHILIPOPOLIS OOD (BG0014)

Plovdiv, , Bulgaria

State Psychiatric Hospital - Sevlievo (BG009)

Sevlievo, , Bulgaria

Medical Center INTERMEDICA (BG0003)

Sofia, , Bulgaria

DCC Mladost-M (BG0004)

Varna, , Bulgaria

DCC Mladost-M Varna OOD (BG0005)

Varna, , Bulgaria

Med Centre Medical plus (BG008)

Varna, , Bulgaria

Center for Mental Health Veliko Tarnovo (BG0013)

Veliko Tarnovo, , Bulgaria

Mental Health Center-Vratsa EOOD (BG0002)

Vratsa, , Bulgaria

Dr.Jan Holan MD, Office of (CZ0003)

Brno, , Czechia

Meditrine s.r.o. - Psychiatricka Ambulance, Lecebne Centrum (CZ0005)

Havířov, , Czechia

Clinline services s.r.o. (CZ0006)

Hostivice, , Czechia

Neuropsychiatrie HK, s.r.o. (CZ0004)

Hradec Králové, , Czechia

A-Shine s.r.o. (CZ0001)

Pilsen, , Czechia

Institute of Neuropsychiatric Care (INEP) (CZ0007)

Prague, , Czechia

Marienthali Kliinik (EE0001)

Tallinn, , Estonia

OU Jaanson & Laane (EE0002)

Tartu, , Estonia

Medical Pratice For Neurology/Psychiatry (DE0003)

Berlin, , Germany

Office of Dr.Kirsten Hahn (DE0002)

Berlin, , Germany

Zentralinstitut fur Seelische Gesundheit (ZI)-Leitung Abteilung Molekulares Neuroimaging (DE0004)

Mannheim, , Germany

Dr. Frank Kuehn MD, Office Of (DE001)

Oranienburg, , Germany

Klinikum der Eberhard-Karls-Universitaet Tuebingen (DE0007)

Tübingen, , Germany

Nyiro Gyula Hospital - OPAI (HU0006)

Budapest, , Hungary

Semmelweis Egyetem-Neurologiai Klinika (HU0005)

Budapest, , Hungary

Bugat Pal Hospital (HU0008)

Gyöngyös, , 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

Hospital Gintermuiza (LV0001)

Jelgava, , Latvia

Jsc Piejuras Slimnica Psychiatry Clinic (LV0003)

Liepāja, , Latvia

Riga Centre Of Psychiatry And Addiction Disorders (LV0002)

Riga, , Latvia

Sigulda Hospital Outpatient Clinic (LV0006)

Sigulda, , Latvia

Gabinet Lekarski Psychiatryczny Ireneusz Kaczorowski (PL0012)

Bełchatów, , Poland

Wlokiennicza Med Specjalistyczna Praktyka Lekarska dr n. med. Tomasz Markowski (PL0005)

Bialystok, , Poland

Med-Ars (Pl0010)

Bydgoszcz, , Poland

Centrum Zdrowia Psychicznego Biomed - Jan Latala (PL0006)

Kielce, , Poland

Przychodnia Syntonia Izabela Chojnowska-Cwiakala (PL0011)

Kielce, , Poland

Syntonia Sp. z o.o. (PL0002)

Pruszcz Gdański, , Poland

Si Inpn Namsu (Ua0003)

Kharkiv, , Ukraine

Si Inpn Namsu (Ua0008)

Kharkiv, , Ukraine

Kherson Regional Psychiatric Hospital (UA0009)

Kherson, , Ukraine

Kiev Regional Specialized Psycho-Narcological Medical Care (UA0005)

Kiev, , Ukraine

Communal Institution Kirovograd Regional Psychiatric Hospital. Donetsk National Medical University, Chair of psychiatry, psychotherapy, narcology and medical psychology (UA0004)

Kropyvnytskyi, , Ukraine

Railway Clinical Hospital #1, Ukr Research Institute, Social And Forensic Psychatriy And Drug Abuse (UA0007)

Kyiv, , Ukraine

Odessa Regional Medical Centre of Mental Health (UA0006)

Odesa, , 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

Vinnitsa National Medical University (UA0002)

Vinnitsa, , Ukraine

Countries

Bulgaria; Czechia; Estonia; Germany; Hungary; Latvia; Poland; Ukraine

References

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.

Reference Type: DERIVED

PMID: 35704951 (View on PubMed)

Other Identifiers

17972A

Identifier Type: -

Identifier Source: org_study_id