Study on Metabolic Parameters of Sertindole in Patients With Schizophrenia

Sponsor

H. Lundbeck A/S (Industry)

Overall Status

Completed

CT.gov ID

NCT00759460

Collaborator

(none)

250

Enrollment

Location

Arms

Duration (Months)

19.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Drug: Sertindole Drug: Olanzapine	Phase 3

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

250 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

An Exploratory Study Conducted as an add-on to Clinical Trial 11286, to Evaluate the Metabolic Effect of up to 12 Weeks Treatment With Sertindole and Olanzapine in Patients With Schizophrenia

Study Start Date :

Mar 1, 2007

Actual Primary Completion Date :

Mar 1, 2008

Actual Study Completion Date :

Apr 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: Sertindole 12 to 20 mg daily after initial up-titration, encapsulated tablets, orally, 84 days
Active Comparator: 2	Drug: Olanzapine 10 to 20 mg daily after initial up-titration, encapsulated tablets, orally, 84 days Other Names: Zyprexa

Arm

Intervention/Treatment

Experimental: 1

Drug: Sertindole

12 to 20 mg daily after initial up-titration, encapsulated tablets, orally, 84 days

Active Comparator: 2

Drug: Olanzapine

10 to 20 mg daily after initial up-titration, encapsulated tablets, orally, 84 days

Other Names:

Zyprexa

Outcome Measures

Primary Outcome Measures

Changes from baseline by treatment and between treatments for each of the components of the metabolic syndrome [12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CN002	Beijing		China	100083

Sponsors and Collaborators

H. Lundbeck A/S

Investigators

Study Director: Email contact via H. Lundbeck A/S, LundbeckClinicalTrials@lundbeck.com

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

H. Lundbeck A/S

ClinicalTrials.gov Identifier:

NCT00759460

Other Study ID Numbers:

11286C

First Posted:

Sep 25, 2008

Last Update Posted:

Sep 20, 2013

Last Verified:

Sep 1, 2013

Keywords provided by H. Lundbeck A/S

Schizophrenia

Additional relevant MeSH terms:

Schizophrenia

Olanzapine

Sertindole

Study Results

No Results Posted as of Sep 20, 2013