Safety and Efficacy of Zicronapine in Patients With Schizophrenia

NCT01295372 | Completed Phase 3

• 2 other identifiers: 13639A2010-022181-28
• Study Type: interventional
• Target: 160
• Locations: 5 countries
• Sites: 24

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.

Conditions

Schizophrenia

Keywords

Schizophrenia; Antipsychotic; Risperidone; Lu 31-130

Outcome Measures

Primary Outcomes (4)

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

  6 months

• To assess the effect of zicronapine versus risperidone on waist circumference

  6 months

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

  6 months

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

  6 months

Secondary Outcomes (13)

• 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.

  6 months

• 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

  6 months

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

  6 months

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

  6 months

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

  6 months

Study Arms (2)

Zicronapine

EXPERIMENTAL

Drug: Zicronapine

Risperidone

ACTIVE COMPARATOR

Drug: Risperidone

Interventions

Zicronapine DRUG

7.5 mg/day; orally

Also known as: Past name: Lu 31-130

Zicronapine

Risperidone DRUG

5 mg/day; orally

Also known as: Risperdal®

Risperidone

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• H. Lundbeck A/S: lead

Study Sites (24)

CZ004

Brno, 602 00, Czechia

Location

CZ001

Brno, 625 00, Czechia

Location

CZ007

Kladno, 27201, Czechia

Location

CZ003

Liberec, 460 63, Czechia

Location

CZ002

Olomouc, 771 11, Czechia

Location

CZ008

Prague, 100 00, Czechia

Location

CZ006

Prague, 110 00, Czechia

Location

CZ005

Sternberk, 785 17, Czechia

Location

EE003

Pärnu, 80012, Estonia

Location

EE001

Tallinn, 10614, Estonia

Location

EE002

Tallinn, 10617, Estonia

Location

EE004

Tartu, 50406, Estonia

Location

FI001

Helsinki, 00250, Finland

Location

FI002

Kellokoski, 04500, Finland

Location

FR001

Clermont-Ferrand, 63003, France

Location

FR002

Nîmes, 30900, France

Location

FR004

Strasbourg, 67091, France

Location

FR003

Toulon, 83000, France

Location

PL004

Bełchatów, 97-400, Poland

Location

PL002

Gdansk, 80-542, Poland

Location

PL003

Kielce, 25-317, Poland

Location

PL006

Lodz, 91-229, Poland

Location

PL001

Lublin, 20-109, Poland

Location

PL005

Żuromin, 93-00, Poland

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Risperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Email contact via H. Lundbeck A/S

  LundbeckClinicalTrials@lundbeck.com

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2011
• First Posted: February 14, 2011
• Study Start: April 1, 2011
• Primary Completion: October 1, 2012
• Last Updated: November 8, 2016

Record last verified: 2016-11

Locations

PL (6); FR (4); FI (2); CZ (8); ES (4)