Comparison of the effects of Sertindole and Olanzapine on Cognition - SEROLA

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-008366-13-DK

Enrollment

100

Registered

2009-01-13

Start date

2009-03-17

Completion date

Unknown

Last updated

2021-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive deficits in patients with schizophrenia MedDRA version: 9.1 Level: LLT Classification code 10019364 Term: Hebephrenic schizophrenia MedDRA version: 9.1 Level: LLT Classification code 10046150 Term: Unspecified schizophrenia MedDRA version: 9.1 Level: LLT Classification code 10052792 Term: Schizophrenia, undifferentiated type MedDRA version: 9.1 Level: LLT Classification code 10007780 Term: Catatonic schizophrenia MedDRA version: 9.1 Level: LLT Classification code 10033877 Term: Pa

Interventions

Trade Name: Serdolect Pharmaceutical Form: Coated tablet INN or Proposed INN: SERTINDOLE CAS Number: 106516249 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 4- Ph

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Both genders 2. Between 18 and 65 years of age 3. The ICD-10 schizophrenia diagnosis F20.0-F20.3 and F20.9 (paranoid, hebephrenic, catatonic, undifferentiated and unspecified) 4. That all fertile women must use a safe form of birth control (birth control pills, spiral, gestagen depot injection, sub dermal implantation, hormonal vaginal ring and transdermal depot patch) 5. A negative pregnancy test for women 6. No known allergy to any of the substances in the study medication 7. Baseline QTc =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Withdrawal of consent 2. QTc prolongation >500 milliseconds 3. Patients with known clinical important cardiovascular disease e.g., heart insufficiency, cardiac hypertrophy, arrhythmia or bradycardia (<50 beats per minute) 4. Significant addictions interfering with outcome and compliance 5. Earlier partial or non-response in treatment or intolerability to sertindole or olanzapine. 6. Calgary Depression Scale score = 7 7. Treatment that interferes with the metabolism of sertindole or olanzapine, e.g. potent inhibitors of CYP1A2, CYP3A4 and CYP2D6, e.g. ketoconazole, fluvoxamine and fluoxetine as described in the SPC of Serdolect 8. Oxazepam, zopiclone or zolpidem treatment the last 48 hours before cognitive testing 9. Prescription of not-allowed medication, or a change in dosage of antidepressant, or mood stabilizers in the study period 10. Treatment with an anticholinergic after the first three weeks of the study 11. Somatic illness, as judged by investigator, interfering with cognition, e.g. delirium 12. Treatment with electroconvulsive therapy (ECT) the last three months before inclusion, or treatment with ECT in the study period 13. Treatment with clozapine or depot antipsychotics before inclusion

Design outcomes

Primary

Measure	Time frame
Main Objective: Is there significant difference in the CANTAB SWM subscale score between the olanzapine and sertindole treatment arm;Secondary Objective: • Sertindole gives a statistical significantly better cognitive outcome on the other CANTAB subscales • No significant difference in efficacy as measured by PANSS total score, or CGI during treatment with sertindole or olanzapine • Sertindole gives statistical significantly less weight gain than olanzapine, and subjectively more satiety • Sertindole gives a statistical significantly increased Quality of Life as compared to olanzapine on total score • Sertindole gives a significantly better functional outcome than olanzapine as measured by Specific Level of Functioning and GAF scales • Sertindole gives a significantly better insight than olanzapine as measured by Beck’s Cognitive Insight Scale • Sertindole has a metabolic profile than olanzapine, as measured by secondary effect parameters ;Primary end point(s): CANTAB cognitive test battery Fasting glucose Lipid profile (including TG, HDL, LDL, total cholesterol) HbA1c Body weight Height Abdominal circumference Blood pressure (measured after ten minutes of rest when the patient is sitting in an upright position) PANSS (psychopathology) 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)	—

Measure

Time frame

Main Objective: Is there significant difference in the CANTAB SWM subscale score between the olanzapine and sertindole treatment arm;Secondary Objective: • Sertindole gives a statistical significantly better cognitive outcome on the other CANTAB subscales • No significant difference in efficacy as measured by PANSS total score, or CGI during treatment with sertindole or olanzapine • Sertindole gives statistical significantly less weight gain than olanzapine, and subjectively more satiety • Sertindole gives a statistical significantly increased Quality of Life as compared to olanzapine on total score • Sertindole gives a significantly better functional outcome than olanzapine as measured by Specific Level of Functioning and GAF scales • Sertindole gives a significantly better insight than olanzapine as measured by Beck’s Cognitive Insight Scale • Sertindole has a metabolic profile than olanzapine, as measured by secondary effect parameters ;Primary end point(s): CANTAB cognitive test battery Fasting glucose Lipid profile (including TG, HDL, LDL, total cholesterol) HbA1c Body weight Height Abdominal circumference Blood pressure (measured after ten minutes of rest when the patient is sitting in an upright position) PANSS (psychopathology) 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)

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Countries

Denmark, Sweden

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026