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Completed

NCT Number: NCT01295372

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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CZ001, Brno, Czechia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Zicronapine

Drug

7.5 mg/day; orally

Other names: Past name: Lu 31-130

Risperidone

Drug

5 mg/day; orally

Other names: Risperdal®

Primary outcomes

  1. To assess the effect of zicronapine versus risperidone on body weight (and BMI)

    Time frame: 6 months

  2. To assess the effect of zicronapine versus risperidone on waist circumference

    Time frame: 6 months

  3. To assess the effect of zicronapine versus risperidone on levels of fasting blood lipids

    Time frame: 6 months

  4. To assess the effect of zicronapine versus risperidone on levels of fasting blood glucose

    Time frame: 6 months

Secondary outcomes

  1. 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

  2. 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

    Abnormal Involuntary Movement Scale (AIMS), Barnes Akathisia Scale (BARS), and Simpson Angus Scale (SAS) total scores

  3. To assess the effect of zicronapine versus risperidone on serum prolactin levels

    Time frame: 6 months

  4. To assess the effect of zicronapine on suicidal ideation and behaviour using the Columbia Suicide-Severity Rating Scale (C-SSRS)

    Time frame: 6 months

  5. To assess the effect of zicronapine versus risperidone on electrocardiogram (ECG) parameters

    Time frame: 6 months

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. To assess the effect of zicronapine versus risperidone on functioning using the Global Assessment of Functioning scale (GAF)

    Time frame: 6 months

  12. 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

  13. 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

Sponsors and collaborators

Lead sponsor

H. Lundbeck A/S

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
First posted
Feb 14, 2011
Registry last updated
Nov 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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