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Safety and Efficacy of Zicronapine in Patients With Schizophrenia

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Zicronapine
Risperidone
Sponsored by
H. Lundbeck A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Antipsychotic, Risperidone, Lu 31-130

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CZ004
  • CZ001
  • CZ007
  • CZ003
  • CZ002
  • CZ008
  • CZ006
  • CZ005
  • EE003
  • EE001
  • EE002
  • EE004
  • FI001
  • FI002
  • FR001
  • FR002
  • FR004
  • FR003
  • PL004
  • PL002
  • PL003
  • PL001
  • PL006
  • PL005

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Zicronapine

Risperidone

Arm Description

Outcomes

Primary Outcome Measures

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 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.
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
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)

Full Information

First Posted
February 3, 2011
Last Updated
November 7, 2016
Sponsor
H. Lundbeck A/S
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1. Study Identification

Unique Protocol Identification Number
NCT01295372
Brief Title
Safety and Efficacy of Zicronapine in Patients With Schizophrenia
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 Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lundbeck A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, Antipsychotic, Risperidone, Lu 31-130

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Zicronapine
Arm Type
Experimental
Arm Title
Risperidone
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Zicronapine
Other Intervention Name(s)
Past name: Lu 31-130
Intervention Description
7.5 mg/day; orally
Intervention Type
Drug
Intervention Name(s)
Risperidone
Other Intervention Name(s)
Risperdal®
Intervention Description
5 mg/day; orally
Primary Outcome Measure Information:
Title
To assess the effect of zicronapine versus risperidone on body weight (and BMI)
Time Frame
6 months
Title
To assess the effect of zicronapine versus risperidone on waist circumference
Time Frame
6 months
Title
To assess the effect of zicronapine versus risperidone on levels of fasting blood lipids
Time Frame
6 months
Title
To assess the effect of zicronapine versus risperidone on levels of fasting blood glucose
Time Frame
6 months
Secondary Outcome Measure Information:
Title
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
Title
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
Description
Abnormal Involuntary Movement Scale (AIMS), Barnes Akathisia Scale (BARS), and Simpson Angus Scale (SAS) total scores
Time Frame
6 months
Title
To assess the effect of zicronapine versus risperidone on serum prolactin levels
Time Frame
6 months
Title
To assess the effect of zicronapine on suicidal ideation and behaviour using the Columbia Suicide-Severity Rating Scale (C-SSRS)
Time Frame
6 months
Title
To assess the effect of zicronapine versus risperidone on electrocardiogram (ECG) parameters
Time Frame
6 months
Title
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
Title
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
Title
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
Title
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
Title
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
Title
To assess the effect of zicronapine versus risperidone on functioning using the Global Assessment of Functioning scale (GAF)
Time Frame
6 months
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Email contact via H. Lundbeck A/S
Organizational Affiliation
LundbeckClinicalTrials@lundbeck.com
Official's Role
Study Director
Facility Information:
Facility Name
CZ004
City
Brno
ZIP/Postal Code
602 00
Country
Czech Republic
Facility Name
CZ001
City
Brno
ZIP/Postal Code
625 00
Country
Czech Republic
Facility Name
CZ007
City
Kladno
ZIP/Postal Code
27201
Country
Czech Republic
Facility Name
CZ003
City
Liberec
ZIP/Postal Code
460 63
Country
Czech Republic
Facility Name
CZ002
City
Olomouc
ZIP/Postal Code
771 11
Country
Czech Republic
Facility Name
CZ008
City
Praha
ZIP/Postal Code
100 00
Country
Czech Republic
Facility Name
CZ006
City
Praha
ZIP/Postal Code
110 00
Country
Czech Republic
Facility Name
CZ005
City
Sternberk
ZIP/Postal Code
785 17
Country
Czech Republic
Facility Name
EE003
City
Pärnu
ZIP/Postal Code
80012
Country
Estonia
Facility Name
EE001
City
Tallinn
ZIP/Postal Code
10614
Country
Estonia
Facility Name
EE002
City
Tallinn
ZIP/Postal Code
10617
Country
Estonia
Facility Name
EE004
City
Tartu
ZIP/Postal Code
50406
Country
Estonia
Facility Name
FI001
City
Helsinki
ZIP/Postal Code
00250
Country
Finland
Facility Name
FI002
City
Kellokoski
ZIP/Postal Code
04500
Country
Finland
Facility Name
FR001
City
Clermont Ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
FR002
City
Nimes
ZIP/Postal Code
30900
Country
France
Facility Name
FR004
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
FR003
City
Toulon
ZIP/Postal Code
83000
Country
France
Facility Name
PL004
City
Bełchatów
ZIP/Postal Code
97-400
Country
Poland
Facility Name
PL002
City
Gdańsk
ZIP/Postal Code
80-542
Country
Poland
Facility Name
PL003
City
Kielce
ZIP/Postal Code
25-317
Country
Poland
Facility Name
PL001
City
Lublin
ZIP/Postal Code
20-109
Country
Poland
Facility Name
PL006
City
Łódź
ZIP/Postal Code
91-229
Country
Poland
Facility Name
PL005
City
Żuromin
ZIP/Postal Code
93-00
Country
Poland

12. IPD Sharing Statement

Available IPD and Supporting Information:
Available IPD/Information Type
EudraCT Results
Available IPD/Information URL
https://www.clinicaltrialsregister.eu/ctr-search/trial/2010-022181-28/result
Available IPD/Information Identifier
2010-022181-28

Learn more about this trial

Safety and Efficacy of Zicronapine in Patients With Schizophrenia

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