A 6-month, randomised, double-blind, parallel-group, risperidone-controlled, fixed-dose study evaluating the safety and efficacy of zicronapine in patients with schizophrenia

• Conditions: Schizophrenia; MedDRA version: 14.1Level: PTClassification code 10052792Term: Schizophrenia, undifferentiated typeSystem Organ Class: 10037175 - Psychiatric disorders; MedDRA version: 14.1Level: PTClassification code 10039637Term: Schizophrenia, catatonic typeSystem Organ Class: 10037175 - Psychiatric disorders; MedDRA version: 14.1Level: PTClassification code 10039639Term: Schizophrenia, paranoid typeSystem Organ Class: 10037175 - Psychiatric disorders; MedDRA version: 14.1Level: PTClassification code 10039638Term: Schizophrenia, disorganised typeSystem Organ Class: 10037175 - Psychiatric disorders

• Registration Number: EUCTR2010-022181-28-CZ
• Lead Sponsor: H. Lundbeck A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01-20
• Last Update Posted: 17 December 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

- The patient meets the DSM-IV-TR criteria for schizophrenia (codes 295.10, 295.20, 295.30, 295.90)
- The patient is a man or woman, =18 and =65 years old
- The patient has a PANSS total score =60 and =100 at screening and baseline

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 160
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- The patient has a current 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 himself/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
- The patient has been treated with an adequate course of risperidone or paliperidone and failed to respond or has shown intolerance to the drug according to the investigator`s judgement

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified