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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

February 3, 2011
October 30, 2012
April 2011
October 2012   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01295372 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Safety and Efficacy of Zicronapine in Patients With Schizophrenia
A 6-month, Randomised, Double-blind, Parallel-group, Risperidone-controlled, Fixed-dose Study Evaluating the Safety and Efficacy of Zicronapine in Patients With Schizophrenia

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Schizophrenia
  • Drug: Zicronapine
    7.5 mg/day; orally
    Other Name: Past name: Lu 31-130
  • Drug: Risperidone
    5 mg/day; orally
    Other Name: Risperdal®
  • Experimental: Zicronapine
    Intervention: Drug: Zicronapine
  • Active Comparator: Risperidone
    Intervention: Drug: Risperidone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
160
Not Provided
October 2012   (final data collection date for primary outcome measure)

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.

Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic,   Estonia,   Finland,   France,   Poland
 
NCT01295372
13639A, 2010-022181-28
No
H. Lundbeck A/S
H. Lundbeck A/S
Not Provided
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
H. Lundbeck A/S
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP