Study on Metabolic Parameters of Sertindole in Patients With Schizophrenia

Lundbeck

Status and phase: Completed; Phase 3

Conditions: Schizophrenia

Treatments: Drug: Olanzapine; Drug: Sertindole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00759460

11286C

Details and patient eligibility

About

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

Full description

The prevalence of metabolic syndrome is estimated to be around 20-25% of the population and is particularly high in patients with schizophrenia. Individuals with metabolic syndrome are twice as likely to die from, and three times as likely to suffer from a heart attack or stroke compared to individuals without the syndrome.

Patients on atypical antipsychotic medication should be considered a high risk group for diabetes and cardiovascular disease. Weight gain is common in patients taking neuroleptics and atypical antipsychotics, and excessive body weight is a risk factor for type 2 diabetes.

Enrollment: 250 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 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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250 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: Sertindole

2

Active Comparator group

Treatment:

Drug: Olanzapine