schizophrenia with persistent prominent negative symptoms MedDRA version: 20.0 Level: PT Classification code 10039626 Term: Schizophrenia System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Product Code: Lu AF11167 modified-release tablet
Pharmaceutical Form: Modified-release tablet
INN or Proposed INN: LU AF11167
Current Sponsor code: LU AF11167 hemiadipate
Other descriptive name: LU
Sponsors
H. Lunbeck A/S
Eligibility
Sex/Gender
All
Inclusion 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 theraphy 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 Both antipsychotics will be withdrawn during the washout phase and need to be discontinued before Screening Visit 2.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 respons
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: A study to evaluate the efficacy of 2 fixed-flexible doses of Lu AF11167 on negative symptoms in patients with schizophrenia;Secondary Objective: N/A;Primary end point(s): 1. Change in Negative Symptom Scale (BNSS) total score ;Timepoint(s) of evaluation of this end point: [1.Time Frame: from baseline to Week 12] | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 2. Change in Personal and Social Performance (PSP) score 3. Change in Positive and Negative Syndrome Scale (PANSS) total score 4. Change in PANSS Marder Negative Symptom Factor score: negative symptoms 5. Change in PANSS Negative subscale score 6. Change in Clinical Global Impression - Schizophrenia (CGI-SCH-S) negative symptoms score 7. Clinical Global Impression - Schizophrenia (CGI-SCH-DC) negative symptoms score 8.CGI-SCH-DC negative symptoms response 9.BNSS response 10.Change in PANSS -Positive subscale score 11.Change in Clinical Global Impression - Schizophrenia (CGI-SCH-S) severity of illness overall severity score 12.Clinical Global Impression - Schizophrenia (CGI-SCH-DC) degree of change in overall severity score 13.Change in Calgary Depression Scale for Schizophrenia (CDSS) total score ;Timepoint(s) of evaluation of this end point: 2.[Time Frame: from baseline to Week 12] 3.[Time Frame: from baseline to Week 12] 4.[Time Frame: from baseline to Week 12], 5.[Time Frame: from baseline to Week 12] 6.[Time Frame: from baseline to Week 12] 7.[Time Frame: at Week 12] 8.[Time Frame: at Week 12] 9.[Time Frame: at Week 12] 10.[Time Frame: from baseline to Week 12] 11.[Time Frame: from baseline to Week 12] 12.[Time Frame: at Week 12] 13.[Time Frame: from baseline to Week 12] | — |
Countries
Bulgaria, Czech Republic, Estonia, Germany, Hungary, Latvia, Russian Federation, Ukraine
Contacts
Public ContactLundbeckClinicalTrials@lundbeck.com
H. Lundbeck A/S
Outcome results
None listed