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| ID | Type | Description | Link |
|---|---|---|---|
| Eudra CT nr: 2008-008366-13 |
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Due to recruitment problems
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| Name | Class |
|---|---|
| Aalborg Psychiatric Hospital | OTHER |
| Malmö University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sertindole | Active Comparator | Sertindole 16-24 mg |
|
| Olanzapine | Active Comparator | Olanzapine 10-20 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sertindole | Drug | Sertindole 16-24 mg once daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| CANTAB cognitive test battery | Baseline - 6 and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| René Nielsen, M.D. | Aalborg Psychiatric Hospital, Aarhus University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalborg Psychiatric Hospital | Aalborg | 9000 | Denmark | |||
| Universitets Allmänna Sjukhuset, Malmø UMAS |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C066304 | sertindole |
| D000077152 | Olanzapine |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Olanzapine | Drug | Olanzapine 10-20 mg |
|
|
| Baseline, 6 and 12 weeks |
| Malmö |
| Sweden |
| D006571 | Heterocyclic Compounds |