Safety and Efficacy of Zicronapine in Patients With Schizophrenia

Condition(s) targeted: Schizophrenia

Intervention: Zicronapine (Drug); Risperidone (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: H. Lundbeck A/S

Official(s) and/or principal investigator(s):
Email contact via H. Lundbeck A/S, Study Director, Affiliation: LundbeckClinicalTrials@lundbeck.com

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.

Official title: A 6-month, Randomised, Double-blind, Parallel-group, Risperidone-controlled, Fixed-dose Study Evaluating the Safety and Efficacy of Zicronapine in Patients With Schizophrenia

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

To assess the effect of zicronapine versus risperidone on body weight (and BMI)

To assess the effect of zicronapine versus risperidone on waist circumference

To assess the effect of zicronapine versus risperidone on levels of fasting blood lipids

To assess the effect of zicronapine versus risperidone on levels of fasting blood glucose

Secondary outcome:

To assess the overall safety and tolerability of zicronapine versus risperidone during 6 months of treatment by comparing the frequencies of adverse events sorted by system organ class and preferred term.

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

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 using the Medication Satisfaction Questionnaire (MSQ)

Detailed description: Schizophrenia is a serious and disabling mental disorder that affects approximately 1% of the world's population. Antipsychotic drugs remain the cornerstone in the pharmacotherapy of schizophrenia. There are a number of antipsychotic drugs in use but none is ideal, in particular because their safety profile is complex and their effectiveness is limited. Thus, present treatment options leave room for improvement and call for new, more effective pharmacotherapies for the treatment of schizophrenia. In the current study, non-acute patients with schizophrenia will be randomised to blinded treatment with either zicronapine or a standard antipsychotic treatment for 24 weeks. The safety (with focus on metabolic parameters) and efficacy of zicronapine will be evaluated in comparison to risperidone.

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- The patient meets the Diagnostic and Statistical Manual of Mental Disorders, 4th

edition, Text Revision (DSM-IV-TR) criteria for schizophrenia

- The patient is a man or woman, ≥18 and ≤65 years old

- The patient has a PANSS total score ≥60 and ≤100 (extremes included) at screening and

baseline Exclusion Criteria:

- The patient has a current, predominant 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 him/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 Other inclusion and exclusion criteria may apply.

CZ001, Brno 625 00, Czech Republic

CZ004, Brno 602 00, Czech Republic

CZ007, Kladno 27201, Czech Republic

CZ003, Liberec 460 63, Czech Republic

CZ002, Olomouc 771 11, Czech Republic

CZ006, Praha 110 00, Czech Republic

CZ008, Praha 100 00, Czech Republic

CZ005, Sternberk 785 17, Czech Republic

EE003, Pärnu 80012, Estonia

EE001, Tallinn 10614, Estonia

EE002, Tallinn 10617, Estonia

EE004, Tartu 50406, Estonia

FI001, Helsinki 00250, Finland

FI002, Kellokoski 04500, Finland

FR001, Clermont Ferrand 63003, France

FR002, Nimes 30900, France

FR004, Strasbourg 67091, France

FR003, Toulon 83000, France

PL004, Bełchatów 97-400, Poland

PL002, Gdańsk 80-542, Poland

PL003, Kielce 25-317, Poland

PL001, Lublin 20-109, Poland

PL006, Łódź 91-229, Poland

PL005, Żuromin 93-00, Poland

Starting date: April 2011
Last updated: October 30, 2012