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The purpose of this study is to investigate the effect of Lu AF35700 on electrical activity in the heart as measured on an electrocardiogram (ECG) in patients with schizophrenia or schizoaffective disorder after 6 weeks of treatment
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lu AF35700 (10 mg/day) | Experimental | Lu AF35700 10 mg/day for 6 weeks |
|
| Lu AF35700 (30 mg/day) | Experimental | Lu AF35700 30 mg/day for 6 weeks |
|
| Quetiapine (Seroquel XR® 800 mg/day) | Experimental | Quetiapine (Seroquel XR®) 800 mg/day for 6 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lu AF35700 (10 mg/day) | Drug | tablets for oral administration once daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from time-matched baseline on day 1, 21, and 42 in QTcF | Before dose to 10 hours post dose |
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Inclusion Criteria:
Exclusion Criteria:´
Other protocol defined inclusion and exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Email contact via H. Lundbeck A/S | LundbeckClinicalTrials@Lundbeck.com | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| US1104 | Long Beach | California | United States |
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| Lu AF35700 (30 mg/day) |
| Drug |
tablets for oral administration once daily |
|
| Quetiapine (Seroquel XR® 800 mg/day) | Drug | tablets for oral administration once daily |
|
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000726227 | Lu AF35700 |
| D000069348 | Quetiapine Fumarate |
| ID | Term |
|---|---|
| D003987 | Dibenzothiazepines |
| D013841 | Thiazepines |
| D013846 | Thiepins |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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