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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-517560-30-00 | EU Trial (CTIS) Number | ||
| 2020-001980-95 | EudraCT Number |
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| Name | Class |
|---|---|
| Arvid Carlsson Research AB | INDUSTRY |
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An explorative, open label, single armed, flexible dose, single center, phase IIa study of 8 weeks, initiated in subjects with bipolar depression. The study will consist of 9 visits and 1 safety visit.
Subjects with a primary diagnosis of bipolar disorder (type 1 or 2) currently in an acute depressive phase (i.e. bipolar depression) and being on stable medication with at least one mood stabilizer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OSU6162 | Experimental | Coated tablet, flexible dosing |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OSU6162 | Drug | OSU6162 |
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| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the Montgomery-Ã…sberg Depression Rating Scale (MADRS) at endpoint [Day 60]. | Endpoint at 60 days treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elias Eriksson, Professor | Contact | + 46 709 555055 | elias.eriksson@neuro.gu.se | |
| Steinn Steingrimsson, MD, PhD | Contact | + 46 722 448372 | steinn.steingrimsson@vgregion.se |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sahlgrenska university hospital/Östra | Recruiting | Gothenburg | SE 405 30 | Sweden |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C109513 | OSU 6162 |
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Open study
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