Exploratory Cognition Study of Sertindole in Patients With Schizophrenia

Lundbeck

Status and phase: Completed; Phase 3

Conditions: Schizophrenia

Treatments: Drug: Sertindole; Drug: Olanzapine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00759421

11286B

Details and patient eligibility

About

The purpose of this exploratory study is to evaluate the effects of sertindole and olanzapine on neurocognitive functioning in patients with schizophrenia.

Full description

Cognitive deficits, including impairments in areas such as memory, attention, and executive function, are major determinants and predictors of long-term disability in schizophrenia. At present, available antipsychotic medications are relatively ineffective in improving cognition. However, scientific discoveries during the past decade suggest that it may be possible to develop medications that are effective in improving cognition in schizophrenia.

One of the important reasons to focus on cognitive deficits as a target for pharmacological treatment, is the association found between cognitive impairment and social dysfunction observed in patients with schizophrenia. Pervasive cognitive deficits have a limiting effect on the quality of life of patients with schizophrenia including social interaction and problem solving, community living, and employment prospects.

Enrollment: 96 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Patients with schizophrenia
• Participation in 11286 study
• Capable of completing all study-related psychometric activities for the duration of the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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96 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: Sertindole

2

Active Comparator group

Treatment:

Drug: Olanzapine