Comparing the Effects of Sertindole and Olanzapine on Cognition (SEROLA)

NCT00885690 | Terminated DMC

• 2 other identifiers: 3.1 - 01-25-09Eudra CT nr: 2008-008366-13
• Study Type: interventional
• Target: 11
• Locations: 2 countries
• Sites: 2

Brief Summary

Cognition is one of the core symptoms of schizophrenia. This study is a head-to-head trial between olanzapine and sertindole with cognition as primary outcome. The design is a 12-week double-blinded randomized controlled flexible dose study.

Conditions

Schizophrenia

Keywords

Schizophrenia; Antipsychotic; Cognition

Outcome Measures

Primary Outcomes (1)

• CANTAB cognitive test battery

  Baseline - 6 and 12 weeks

Secondary Outcomes (2)

• Fasting glucose, lipid profile, HbA1c, body weight, abdominal circumference, blood pressure

  Baseline - 6 and 12 weeks

• PANSS, CGI, Sf-36 (quality of life), GAF (social function), UKU (side effects), DAI (attitude towards medicine), Beck's insight scale, Specific Level of Functioning (SLOF)

  Baseline, 6 and 12 weeks

Study Arms (2)

Sertindole

ACTIVE COMPARATOR

Sertindole 16-24 mg

Drug: Sertindole

Olanzapine

ACTIVE COMPARATOR

Olanzapine 10-20 mg

Drug: Olanzapine

Interventions

Sertindole DRUG

Sertindole 16-24 mg once daily

Also known as: Serdolect

Sertindole

Olanzapine DRUG

Olanzapine 10-20 mg

Also known as: Zyprexa

Olanzapine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• AnICD-10 schizophrenia diagnosis F20.0-F20.9.
• Contraception.
• A negative pregnancy test for women.
• No known allergy to any of the substances in the study medication
• Baseline QTc \< 450 milliseconds for men and \< 470 milliseconds for women
• S-potassium and s-magnesium within normal reference range.
• Suboptimally treated on current antipsychotic medication
• Signed informed consent and power of attorney

You may not qualify if:

• Withdrawal of consent
• QTc prolongation \>500 milliseconds during the study
• Patients with known clinical important cardiovascular disease
• Significant substance abuse
• Earlier partial or non-response in treatment or intolerability to sertindole or olanzapine.
• Calgary Depression Scale score ≥ 7
• Treatment that interferes with the metabolism of sertindole or olanzapine,
• Oxazepam, zopiclone or zolpidem treatment the last 48 hours before cognitive testing
• Prescription of not-allowed medication, or a change in dosage of antidepressant, or mood stabilizers in the study period
• Treatment with an anticholinergic after the first three weeks of the study
• Somatic illness, as judged by investigator, interfering with cognition
• Known risk of narrow angle glaucoma

Sponsors & Collaborators

• University of Aarhus: lead
• Aalborg Psychiatric Hospital: collaborator
• Malmö University: collaborator

Study Sites (2)

Aalborg Psychiatric Hospital

Aalborg, 9000, Denmark

Location

Universitets Allmänna Sjukhuset, Malmø UMAS

Malmo, Sweden

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

sertindole; Olanzapine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• René Nielsen, M.D.

  Aalborg Psychiatric Hospital, Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2009
• First Posted: April 22, 2009
• Study Start: April 1, 2009
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: September 4, 2013

Record last verified: 2013-09

Locations

DK (1); SE (1)