Safety and Efficacy of Zicronapine in Patients With Schizophrenia
- Registration Number
- NCT01295372
- Lead Sponsor
- H. Lundbeck A/S
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 160
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Risperidone Risperidone - Zicronapine Zicronapine -
- Primary Outcome Measures
Name Time Method To assess the effect of zicronapine versus risperidone on levels of fasting blood lipids 6 months To assess the effect of zicronapine versus risperidone on levels of fasting blood glucose 6 months To assess the effect of zicronapine versus risperidone on body weight (and BMI) 6 months To assess the effect of zicronapine versus risperidone on waist circumference 6 months
- Secondary Outcome Measures
Name Time Method 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 6 months Abnormal Involuntary Movement Scale (AIMS), Barnes Akathisia Scale (BARS), and Simpson Angus Scale (SAS) total scores
To assess the effect of zicronapine versus risperidone on electrocardiogram (ECG) parameters 6 months To assess the effect of zicronapine on suicidal ideation and behaviour using the Columbia Suicide-Severity Rating Scale (C-SSRS) 6 months 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 To assess the effect of zicronapine versus risperidone on personal and social functioning using the Personal and Social Performance Scale (PSP) 6 months To assess the effect of zicronapine versus risperidone on the patient's satisfaction with treatment using the Medication Satisfaction Questionnaire (MSQ) 6 months 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 To assess the effect of zicronapine versus risperidone on serum prolactin levels 6 months 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 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 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 To assess the effect of zicronapine versus risperidone on functioning using the Global Assessment of Functioning scale (GAF) 6 months 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
Trial Locations
- Locations (24)
FR004
🇫🇷Strasbourg, France
CZ001
🇨🇿Brno, Czech Republic
FR003
🇫🇷Toulon, France
CZ008
🇨🇿Praha, Czech Republic
FR002
🇫🇷Nimes, France
FR001
🇫🇷Clermont Ferrand, France
PL004
🇵🇱Bełchatów, Poland
CZ006
🇨🇿Praha, Czech Republic
EE003
🇪🇪Pärnu, Estonia
FI001
🇫🇮Helsinki, Finland
PL002
🇵🇱Gdańsk, Poland
CZ004
🇨🇿Brno, Czech Republic
PL006
🇵🇱Łódź, Poland
EE001
🇪🇪Tallinn, Estonia
EE002
🇪🇪Tallinn, Estonia
PL005
🇵🇱Żuromin, Poland
EE004
🇪🇪Tartu, Estonia
CZ007
🇨🇿Kladno, Czech Republic
CZ003
🇨🇿Liberec, Czech Republic
CZ002
🇨🇿Olomouc, Czech Republic
CZ005
🇨🇿Sternberk, Czech Republic
FI002
🇫🇮Kellokoski, Finland
PL003
🇵🇱Kielce, Poland
PL001
🇵🇱Lublin, Poland