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The research project has been cancelled before any participants were enrolled.
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| Name | Class |
|---|---|
| Soon Chun Hyang University | OTHER |
The investigators will assess Li-induced gray matter volume changes with regard to the endophenotype of GSK3beta polymorphism. The changes of gray matter are supposed to be more attributable to neurotrophic and neuroprotective characteristics of Li, which were closely related to the inhibition of apoptotic activity of GSK3beta.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lithium | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lithium | Drug | 10mg/kg/day for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in manic symptom scores at 12 weeks | Baseline and at 12 weeks | |
| Change from baseline in manic symptom scores at 8 weeks | Baseline and at 8 weeks | |
| Change from baseline in manic symptom scores at 4 weeks | Baseline and at 4 weeks | |
| Change from baseline in manic symptom scores at 1 week | Baseline and at 1 week | |
| Change from baseline in depressive symptom scores at 12 weeks | Baseline and at 12 weeks | |
| Change from baseline in depressive symptom scores at 8 weeks | Baseline and at 8 weeks | |
| Change from baseline in depressive symptom scores at 4 weeks | Baseline and at 4 weeks | |
| Change from baseline in depressive symptom scores at 1 week | Baseline and at 1 week | |
| Change from baseline in global function scores at 12 weeks | Baseline and at 12 weeks | |
| Change from baseline in global function scores at 8 weeks | Baseline and at 8 weeks | |
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline in brain structure analyzed using computational approach | Baseline and at 12 weeks | |
| Number of participants with adverse events | 12 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 110-744 | South Korea |
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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 |
|---|---|
| D008094 | Lithium |
| ID | Term |
|---|---|
| D008672 | Metals, Alkali |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D019565 | Metals, Light |
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| Change from baseline in global function scores at 4 weeks |
| Baseline and at 4 weeks |
| Change from baseline in global function scores at 1 week | Baseline and at 1 week |
| Number of participants with adverse events |
| 8 weeks |
| Number of participants with adverse events | 4 weeks |
| Number of participants with adverse events | 1 week |
| D008670 |
| Metals |