Safety and Efficacy of Zicronapine in Patients With Schizophrenia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S
ClinicalTrials.gov Identifier:
NCT01295372
First received: February 3, 2011
Last updated: October 30, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Drug: Zicronapine
Drug: Risperidone
Phase 3

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

Resource links provided by NLM:


Further study details as provided by H. Lundbeck A/S:

Primary Outcome Measures:
  • To assess the effect of zicronapine versus risperidone on body weight (and BMI) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • To assess the effect of zicronapine versus risperidone on waist circumference [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • To assess the effect of zicronapine versus risperidone on levels of fasting blood lipids [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • To assess the effect of zicronapine versus risperidone on levels of fasting blood glucose [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • 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 [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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 serum prolactin levels [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • To assess the effect of zicronapine on suicidal ideation and behaviour using the Columbia Suicide-Severity Rating Scale (C-SSRS) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • To assess the effect of zicronapine versus risperidone on electrocardiogram (ECG) parameters [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • 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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • 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) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • 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) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • To assess the effect of zicronapine versus risperidone on personal and social functioning using the Personal and Social Performance Scale (PSP) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • To assess the effect of zicronapine versus risperidone on functioning using the Global Assessment of Functioning scale (GAF) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • To assess the effect of zicronapine versus risperidone on quality of life using the disease-specific Schizophrenia Quality of Life scale (S-QoL) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • To assess the effect of zicronapine versus risperidone on the patient's satisfaction with treatment using the Medication Satisfaction Questionnaire (MSQ) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 160
Study Start Date: April 2011
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Zicronapine Drug: Zicronapine
7.5 mg/day; orally
Other Name: Past name: Lu 31-130
Active Comparator: Risperidone Drug: Risperidone
5 mg/day; orally
Other Name: Risperdal®

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01295372

Locations
Czech Republic
CZ001
Brno, Czech Republic, 625 00
CZ004
Brno, Czech Republic, 602 00
CZ007
Kladno, Czech Republic, 27201
CZ003
Liberec, Czech Republic, 460 63
CZ002
Olomouc, Czech Republic, 771 11
CZ006
Praha, Czech Republic, 110 00
CZ008
Praha, Czech Republic, 100 00
CZ005
Sternberk, Czech Republic, 785 17
Estonia
EE003
Pärnu, Estonia, 80012
EE002
Tallinn, Estonia, 10617
EE001
Tallinn, Estonia, 10614
EE004
Tartu, Estonia, 50406
Finland
FI001
Helsinki, Finland, 00250
FI002
Kellokoski, Finland, 04500
France
FR001
Clermont Ferrand, France, 63003
FR002
Nimes, France, 30900
FR004
Strasbourg, France, 67091
FR003
Toulon, France, 83000
Poland
PL004
Bełchatów, Poland, 97-400
PL002
Gdańsk, Poland, 80-542
PL003
Kielce, Poland, 25-317
PL001
Lublin, Poland, 20-109
PL006
Łódź, Poland, 91-229
PL005
Żuromin, Poland, 93-00
Sponsors and Collaborators
H. Lundbeck A/S
Investigators
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
  More Information

No publications provided

Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT01295372     History of Changes
Other Study ID Numbers: 13639A, 2010-022181-28
Study First Received: February 3, 2011
Last Updated: October 30, 2012
Health Authority: Czech Republic: State Institute for Drug Control
Estonia: The State Agency of Medicine
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Keywords provided by H. Lundbeck A/S:
Schizophrenia
Antipsychotic
Risperidone
Lu 31-130

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Risperidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on July 31, 2014