Flexible-dose Long-term Extension Study of Lu AF11167 in Patients With Schizophrenia With Prominent Negative Symptoms

Phase 2TerminatedNCT03929497

H. Lundbeck A/S96 enrolled

Overview

A study to evaluate the long-term safety and tolerability of flexible doses of Lu AF11167 in patients with schizophrenia during the 24-week treatment period

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Schizophrenia

Interventions

Lu AF11167DRUG

Lu AF11167 - 2 or 4 mg/day; tablets, orally

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * The patient completed Study 17972A. * The patient and the patient's caregiver or identified responsible person is able to read and understand the Informed Consent Form. * The patient has signed the Informed Consent Form specific for Study 17972B. * The patient can potentially benefit from 24 weeks of treatment with Lu AF11167 according to the investigator's clinical judgment. Exclusion Criteria: * The patient has any current primary psychiatric disorder other than schizophrenia diagnosed during study 17972A * The patient, in the opinion of the investigator, is at significant risk of suicide Other in- and exclusion criteria may apply

Locations (30)

Outcomes

Primary Outcomes

Number of participants with Treatment-Emergent Adverse Events

Safety and Tolerability based on the safety assessments (clinical safety laboratory tests, vital signs, BMI, waist, weight, ECG parameters)

Time frame: From baseline week 24

Secondary Outcomes

Change in Brief 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.

Time frame: from baseline to Week 24

Change in Positive and Negative Syndrome Scale (PANSS) Marder Negative Symptoms Factor 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: 7 items make up the positive scale (for example: delusions, conceptual disorganization and hallucinatory behaviour), 7 items make up the negative scale (for example: blunted affect, emotional withdrawal and poor rapport) and 16 items make up the general psychopathology scale (for example: somatic concern, anxiety and guilt feelings). Each item is rated from 1 (symptom not present) to 7 (symptom extremely severe). The PANSS total score is the sum of all items, and ranges from 30 to 210. Subscale scores are the sum of items within each subscale.

Time frame: from baseline to Week 24

Change in PANSS Negative subscale score

Data from ClinicalTrials.gov

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

Burgas, Bulgaria

MHAT Dr. Hristo Stambolski (BG0007)

Kazanlak, 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

State Psychiatric Hospital - Sevlievo (BG0009)

Sevlievo, Bulgaria

Medical Center INTERMEDICA (BG0003)

Sofia, Bulgaria

DCC Mladost-M (BG0004)

Varna, Bulgaria

Med Centre Medical plus (BG0008)

Varna, Bulgaria

DCC Mladost-M Varna OOD (BG0005)

Varna, Bulgaria

Mental Health Center-Vratsa EOOD (BG0002)

Vratsa, Bulgaria

...and 20 more locations

Change in 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-severity of illness 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.

Time frame: from baseline to Week 24

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. The CGI-SCH-degree of change 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 change) and overall ratings of severity and improvement are scored independently and no total score is derived.CGI-SCH-DC negative symptoms response is defined as a CGI-SCH-DC negative symptoms score of 1 or 2.

Time frame: at Week 24