A randomised, double-blind, parallel-group, fixed-dose study exploring the efficacy and safety of Lu AE58054 as augmentation therapy to risperidone in patient with schizophrenia

• Conditions: schizophrenia; MedDRA version: 14.1Level: PTClassification code 10039626Term: SchizophreniaSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2008-001441-26-IT
• Lead Sponsor: H. Lundbeck A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-17
• Last Update Posted: 7 January 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

The patients to be included in this study are men or women, with a primary diagnosis of schizophrenia, for whom a change in antipsychotic treatment is indicated since they are only partially responding to their current risperidone treatment. The partial response should not be due to poor compliance to this treatment. The patients must have clinically significant symptoms at screening and baseline and be on an optimised dose of risperidone for the last 4 weeks prior to screening and during the 2-week run-in period prior to baseline, with an absence of acute exacerbations. The patient signed informed consent prior to the conduct of any study specific procedures. The patient has a primary diagnosis of schizophrenia according to the Diagnostics and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR). The patient is a man or woman aged between 18 and 65 years (extremes included). The patient has been on an optimised dose of risperidone (within 4-8 mg/day) for the treatment of schizophrenia for a minimum of 4 weeks prior to screening and during the 2-week lead-in period prior to baseline. The patient has a PANSS total score between 70 and 100 (extremes included) at screening and has had an improvement of <20% in the PANSS total score at baseline. The patient has a score of 4 (moderate) on the following three PANSS items at screening and baseline:  P2 (conceptual disorganisation)  P7 (hostility)  G8 (uncooperativeness) The patient has a CGI-S score of ≥4 (moderately ill) at screening and baseline.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
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 primary psychiatric diagnosis other than schizophrenia according to the DSM-IV-TR criteria. The patient is in an emergency situation for urgent relief of symptoms. The patient has had an acute exacerbation requiring hospitalisation within the last 6 weeks. The patient has a diagnosis of mental retardation or history of pervasive developmental disorder. The patient has clinically significant extrapyramidal symptoms (SAS score >6). The patient has abused drugs or alcohol within the last 6 months preceding the study. The patient is resistant to antipsychotic treatment, according to the investigator s judgement. The patient has been treated with an antipsychotic, other than risperidone, within 4 weeks prior to screening.

Study & Design

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