Safety and Efficacy of Zicronapine in Patients With Schizophrenia

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01295372
• Other study ID #: 13639A
• Secondary ID: 2010-022181-28
• Status: Completed
• Phase: Phase 3
• First received: February 3, 2011
• Last updated: November 7, 2016
• Start date: April 2011

Study information

• Verified date: November 2016
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: State Institute for Drug ControlEstonia: The State Agency of MedicineFinland: Finnish Medicines AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Zicronapine
7.5 mg/day; orally
• Risperidone
5 mg/day; orally

Locations

Country	Name	City	State
Czech Republic	CZ001	Brno
Czech Republic	CZ004	Brno
Czech Republic	CZ007	Kladno
Czech Republic	CZ003	Liberec
Czech Republic	CZ002	Olomouc
Czech Republic	CZ006	Praha
Czech Republic	CZ008	Praha
Czech Republic	CZ005	Sternberk
Estonia	EE003	Pärnu
Estonia	EE001	Tallinn
Estonia	EE002	Tallinn
Estonia	EE004	Tartu
Finland	FI001	Helsinki
Finland	FI002	Kellokoski
France	FR001	Clermont Ferrand
France	FR002	Nimes
France	FR004	Strasbourg
France	FR003	Toulon
Poland	PL004	Belchatów
Poland	PL002	Gdansk
Poland	PL003	Kielce
Poland	PL006	Lódz
Poland	PL001	Lublin
Poland	PL005	Zuromin

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Countries where clinical trial is conducted

Czech Republic,  Estonia,  Finland,  France,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the effect of zicronapine versus risperidone on body weight (and BMI)		6 months	Yes
Primary	To assess the effect of zicronapine versus risperidone on waist circumference		6 months	Yes
Primary	To assess the effect of zicronapine versus risperidone on levels of fasting blood lipids		6 months	Yes
Primary	To assess the effect of zicronapine versus risperidone on levels of fasting blood glucose		6 months	Yes
Secondary	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.		6 months	Yes
Secondary	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	Abnormal Involuntary Movement Scale (AIMS), Barnes Akathisia Scale (BARS), and Simpson Angus Scale (SAS) total scores	6 months	Yes
Secondary	To assess the effect of zicronapine versus risperidone on serum prolactin levels		6 months	Yes
Secondary	To assess the effect of zicronapine on suicidal ideation and behaviour using the Columbia Suicide-Severity Rating Scale (C-SSRS)		6 months	Yes
Secondary	To assess the effect of zicronapine versus risperidone on electrocardiogram (ECG) parameters		6 months	Yes
Secondary	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		6 months	No
Secondary	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)		6 months	No
Secondary	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)		6 months	No
Secondary	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		6 months	No
Secondary	To assess the effect of zicronapine versus risperidone on personal and social functioning using the Personal and Social Performance Scale (PSP)		6 months	No
Secondary	To assess the effect of zicronapine versus risperidone on functioning using the Global Assessment of Functioning scale (GAF)		6 months	No
Secondary	To assess the effect of zicronapine versus risperidone on quality of life using the disease-specific Schizophrenia Quality of Life scale (S-QoL)		6 months	No
Secondary	To assess the effect of zicronapine versus risperidone on the patient's satisfaction with treatment using the Medication Satisfaction Questionnaire (MSQ)		6 months	No