The study is measuring the safety and effect of the study drug zicronapine in the treatment of patients with schizophrenia. Patients will receive either the study drug (zicronapine) or risperidone based on a computer-aided random draw, and no one involved in the study will know what treatment is given until the study has finished.

• Conditions: Schizophrenia; MedDRA version: 14.0Level: PTClassification code 10039638Term: Schizophrenia, disorganised typeSystem Organ Class: 10037175 - Psychiatric disorders; MedDRA version: 14.0Level: PTClassification code 10039639Term: Schizophrenia, paranoid typeSystem Organ Class: 10037175 - Psychiatric disorders; MedDRA version: 14.0Level: PTClassification code 10052792Term: Schizophrenia, undifferentiated typeSystem Organ Class: 10037175 - Psychiatric disorders; MedDRA version: 14.0Level: PTClassification code 10039637Term: Schizophrenia, catatonic typeSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-21
• Last Update Posted: 21 January 2013

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