Safety and Efficacy of Zicronapine in Patients With Schizophrenia
Information source: H. Lundbeck A/S
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
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
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.
Clinical Details
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.
Eligibility
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.
Locations and Contacts
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
Additional Information
Starting date: April 2011
Last updated: October 30, 2012
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