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Safety and Efficacy of Zicronapine in Patients With Schizophrenia

NCT ID: NCT01295372

Last Updated: 2016-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Brief Summary

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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

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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.

Conditions

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Schizophrenia

Keywords

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Schizophrenia Antipsychotic Risperidone Lu 31-130

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Zicronapine

Group Type EXPERIMENTAL

Zicronapine

Intervention Type DRUG

7.5 mg/day; orally

Risperidone

Group Type ACTIVE_COMPARATOR

Risperidone

Intervention Type DRUG

5 mg/day; orally

Interventions

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Zicronapine

7.5 mg/day; orally

Intervention Type DRUG

Risperidone

5 mg/day; orally

Intervention Type DRUG

Other Intervention Names

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Past name: Lu 31-130 Risperdal®

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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H. Lundbeck A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Email contact via H. Lundbeck A/S

Role: STUDY_DIRECTOR

[email protected]

Locations

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CZ004

Brno, , Czechia

Site Status

CZ001

Brno, , Czechia

Site Status

CZ007

Kladno, , Czechia

Site Status

CZ003

Liberec, , Czechia

Site Status

CZ002

Olomouc, , Czechia

Site Status

CZ008

Prague, , Czechia

Site Status

CZ006

Prague, , Czechia

Site Status

CZ005

Sternberk, , Czechia

Site Status

EE003

Pärnu, , Estonia

Site Status

EE001

Tallinn, , Estonia

Site Status

EE002

Tallinn, , Estonia

Site Status

EE004

Tartu, , Estonia

Site Status

FI001

Helsinki, , Finland

Site Status

FI002

Kellokoski, , Finland

Site Status

FR001

Clermont-Ferrand, , France

Site Status

FR002

Nîmes, , France

Site Status

FR004

Strasbourg, , France

Site Status

FR003

Toulon, , France

Site Status

PL004

Bełchatów, , Poland

Site Status

PL002

Gdansk, , Poland

Site Status

PL003

Kielce, , Poland

Site Status

PL006

Lodz, , Poland

Site Status

PL001

Lublin, , Poland

Site Status

PL005

Żuromin, , Poland

Site Status

Countries

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Czechia Estonia Finland France Poland

Study Documents

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Document Type: EudraCT Results

View Document

Other Identifiers

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2010-022181-28

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

13639A

Identifier Type: -

Identifier Source: org_study_id