The study is measuring the safety and effect of the study drug zicronapine in the treatment of patients with schizophrenia. Patients will receive either the study drug (zicronapine) or risperidone based on a computer-aided random draw, and no one involved in the study will know what treatment is given until the study has finished.

A 6-month, randomised, double-blind, parallel-group, risperidone-controlled, fixed-dose study evaluating the safety and efficacy of zicronapine in patients with schizophrenia

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-022181-28-FI

Enrollment

160

Registered

2010-12-21

Start date

2011-02-07

Completion date

Unknown

Last updated

2013-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia MedDRA version: 14.0 Level: PT Classification code 10039638 Term: Schizophrenia, disorganised type System Organ Class: 10037175 - Psychiatric disorders MedDRA version: 14.0 Level: PT Classification code 10039639 Term: Schizophrenia, paranoid type System Organ Class: 10037175 - Psychiatric disorders MedDRA version: 14.0 Level: PT Classification code 10052792 Term: Schizophrenia, undifferentiated type System Organ Class: 10037175 - Psychiatric disorders MedDRA version: 14.0 Level

Interventions

Product Name: Zicronapine Product Code: Lu 31-130 Pharmaceutical Form: Capsule INN or Proposed INN: Zicronapine Current Sponsor code: Lu 31-130 Other descriptive name: Zicronapine Concentration unit:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - The patient meets the DSM-IV-TR criteria for schizophrenia (codes 295.10, 295.20, 295.30, 295.90) - The patient is a man or woman, =18 and =65 years old - The patient has a PANSS total score =60 and =100 at screening and baseline Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 160 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - The patient has a current Axis I psychiatric disorder other than schizophrenia as defined in the DSM-IV-TR - The patient has a current diagnosis or a history of substance dependence (except nicotine) or substance abuse (except cannabis) according to the DSM-IV-TR? criteria =6 months prior to screening - The patient is at significant risk of harming himself/herself or others according to the investigator’s judgement (assisted by the assessment of suicidal ideation and behaviour using the C-SSRS) - The patient is resistant to antipsychotic treatment according to the investigator’s judgement or has been treated with clozapine = 3 months prior to screening - The patient has experienced an acute exacerbation requiring hospitalisation = 3 months prior to screening or between screening and baseline - The patient has been treated with risperidone or paliperidone =6 months prior to screening - The patient has been treated with an adequate course of risperidone or paliperidone and failed to respond or has shown intolerance to the drug according to the investigator`s judgement

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the effect of zicronapine versus risperidone on metabolic parameters comprising body weight, BMI, waist circumference, levels of fasting blood lipids and glucose during 6 months of treatment;Secondary Objective: - to assess the overall safety and tolerability of zicronapine (ZIC) versus risperidone (RIS) - to assess the potential of ZIC versus RIS to induce EPS - to assess the effect of ZIC versus RIS on serum prolactin levels - to assess the effect of ZIC on suicidal ideation and behaviour - to assess the effect of ZIC versus RIS on ECG - to assess the efficacy of ZIC versus RIS - to assess the efficacy of ZIC versus RIS by comparing the proportions of responders - to assess the efficacy of ZIC versus RIS on global improvement - to assess the effect of ZIC versus RIS on personal and social functioning - to assess the effect of ZIC versus RIS on functioning - to assess the effect of ZIC versus RIS on quality of life - to assess the effect of ZIC versus RIS on the patient’s satisfaction with treatment - to assess the PK properties of ZIC and its major metabolite Lu AA22774 - to explore biological parameters;Primary end point(s): To assess the effect of zicronapine versus risperidone on metabolic parameters comprising body weight, body mass index (BMI), waist circumference, levels of fasting blood lipids and glucose during 6 months of treatment;Timepoint(s) of evaluation of this end point: Evaluation at the end of the study	—

Measure

Time frame

Main Objective: To assess the effect of zicronapine versus risperidone on metabolic parameters comprising body weight, BMI, waist circumference, levels of fasting blood lipids and glucose during 6 months of treatment;Secondary Objective: - to assess the overall safety and tolerability of zicronapine (ZIC) versus risperidone (RIS) - to assess the potential of ZIC versus RIS to induce EPS - to assess the effect of ZIC versus RIS on serum prolactin levels - to assess the effect of ZIC on suicidal ideation and behaviour - to assess the effect of ZIC versus RIS on ECG - to assess the efficacy of ZIC versus RIS - to assess the efficacy of ZIC versus RIS by comparing the proportions of responders - to assess the efficacy of ZIC versus RIS on global improvement - to assess the effect of ZIC versus RIS on personal and social functioning - to assess the effect of ZIC versus RIS on functioning - to assess the effect of ZIC versus RIS on quality of life - to assess the effect of ZIC versus RIS on the patient’s satisfaction with treatment - to assess the PK properties of ZIC and its major metabolite Lu AA22774 - to explore biological parameters;Primary end point(s): To assess the effect of zicronapine versus risperidone on metabolic parameters comprising body weight, body mass index (BMI), waist circumference, levels of fasting blood lipids and glucose during 6 months of treatment;Timepoint(s) of evaluation of this end point: Evaluation at the end of the study

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Secondary

Measure	Time frame
Secondary end point(s): Safety endpoints: • To assess the overall safety and tolerability of zicronapine versus risperidone during 6 months of treatment • To assess the potential of zicronapine versus risperidone to induce extrapyramidal symptoms using change from baseline to each assessment in the AIMS, BARS, and SAS total scores • To assess the effect of zicronapine versus risperidone on serum prolactin levels • To assess the effect of zicronapine on suicidal ideation and behaviour using the Columbia Suicide-Severity Rating Scale (C-SSRS) • To assess the effect of zicronapine versus risperidone on electrocardiogram (ECG) parameters Efficacy endpoints: • To assess the efficacy of zicronapine versus risperidone following 6 months of treatment using change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score • To assess the efficacy of zicronapine versus risperidone using change from baseline to each assessment in the PANSS total score and PANSS subscale scores (Positive Symptoms, Negative Symptoms, and General Psychopathology • To assess the efficacy of zicronapine versus risperidone by comparing the proportions of responders (using two definitions of response: =20% and =50% decrease from baseline in PANSS total score) • To assess the efficacy of zicronapine versus risperidone on global improvement using change from baseline to each assessment in the Clinical Global Impression – Severity of Illness (CGI-S) score • To assess the effect of zicronapine versus risperidone on personal and social functioning using the Personal and Social Performance Scale (PSP) • To assess the effect of zicronapine versus risperidone on functioning using the Global Assessment of Functioning scale (GAF) • To assess the effect of zicronapine versus risperidone on quality of life using the disease-specific Schizophrenia Quality of Life scale (S-QoL) • To assess the effect of zicronapine versus risperidone on the patient’s satisfaction with treatment	—

Measure

Time frame

Secondary end point(s): Safety endpoints: • To assess the overall safety and tolerability of zicronapine versus risperidone during 6 months of treatment • To assess the potential of zicronapine versus risperidone to induce extrapyramidal symptoms using change from baseline to each assessment in the AIMS, BARS, and SAS total scores • To assess the effect of zicronapine versus risperidone on serum prolactin levels • To assess the effect of zicronapine on suicidal ideation and behaviour using the Columbia Suicide-Severity Rating Scale (C-SSRS) • To assess the effect of zicronapine versus risperidone on electrocardiogram (ECG) parameters Efficacy endpoints: • To assess the efficacy of zicronapine versus risperidone following 6 months of treatment using change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score • To assess the efficacy of zicronapine versus risperidone using change from baseline to each assessment in the PANSS total score and PANSS subscale scores (Positive Symptoms, Negative Symptoms, and General Psychopathology • To assess the efficacy of zicronapine versus risperidone by comparing the proportions of responders (using two definitions of response: =20% and =50% decrease from baseline in PANSS total score) • To assess the efficacy of zicronapine versus risperidone on global improvement using change from baseline to each assessment in the Clinical Global Impression – Severity of Illness (CGI-S) score • To assess the effect of zicronapine versus risperidone on personal and social functioning using the Personal and Social Performance Scale (PSP) • To assess the effect of zicronapine versus risperidone on functioning using the Global Assessment of Functioning scale (GAF) • To assess the effect of zicronapine versus risperidone on quality of life using the disease-specific Schizophrenia Quality of Life scale (S-QoL) • To assess the effect of zicronapine versus risperidone on the patient’s satisfaction with treatment

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Countries

Czech Republic, Estonia, Finland, Poland

Contacts

Public ContactRana Radmard

H. Lundbeck A/S

LundbeckClinicalTrials@lundbeck.com+4536301311

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026