Exploratory Cognition Study of Sertindole in Patients With Schizophrenia

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00759421
• Date of registration: 24/09/2008
• Prospective Registration: No
• Primary sponsor: H. Lundbeck A/S
• Public title: Exploratory Cognition Study of Sertindole in Patients With Schizophrenia
• Scientific title: An Exploratory Cognition Study Conducted as an add-on to Clinical Trial 11286, to Evaluate the Neurocognitive Effects of 12 Weeks Treatment With Sertindole and Olanzapine in Patients With Schizophrenia
• Date of first enrolment: October 2006
• Target sample size: 96
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00759421
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Taiwan

Contacts

• Name: Email contact via H. Lundbeck A/S
• Affiliation: [e-mail]

Key inclusion & 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Schizophrenia

Intervention(s)

Drug: Sertindole

Drug: Olanzapine

Primary Outcome(s)

Global cognitive composite score [Time Frame: 12 weeks]

Secondary Outcome(s)

Cognitive performance in the following domains: 1) Working memory; 2) Attention and vigilance; 3) Verbal learning and memory; 4) Visual learning and memory; 5) Reasoning and problem solving; 6) Speed of processing [Time Frame: 12 weeks]

Secondary ID(s)

11286B

Source(s) of Monetary Support

Please refer to primary and secondary sponsors