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The research project has been cancelled before any participants were enrolled.
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This proposed research is aimed to investigate the efficacy and safety of combined cytidine- and creatine-containing drug and dietary supplement in treating bipolar depression and to evaluate changes in relevant brain biochemical metabolism using magnetic resonance spectroscopy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Valproate+Cytidine-+Creatine- | Experimental | The subjects with bipolar depression, treated with cytidine- and creatine-containing drug and dietary supplement in addition to valproate |
|
| Valproate+Cytidine- | Active Comparator | The subjects with bipolar depression, treated with cytidine-containing drug and dietary supplement in addition to valproate |
|
| Valproate | Active Comparator | The subjects with bipolar depression, treated with valproate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Valproate+Cytidine-+Creatine- | Drug | Valproate: Week0-8: 300mg/day, Cytidine-: Week0-8: 2g/day, Creatine-: Week0-1: 3g/day Week1-8: 5g/day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in depressive symptom scores at 4 weeks | Baseline and at 4 weeks | |
| Change from baseline in depressive symptom scores at 8 weeks | Baseline and at 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in brain Glx (glutamate+glutamine) level assessed using magnetic resonance spectroscopy at baseline and 8 weeks | Baseline and at 8 weeks | |
| Number of participants with adverse events | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| In Kyoon Lyoo, MD, PhD, MMS | Ewha Womans University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ewha Womans University Medical Center | Seoul | 158-710 | 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 |
|---|---|
| D014635 | Valproic Acid |
| ID | Term |
|---|---|
| D010421 | Pentanoic Acids |
| D014631 | Valerates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
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| Valproate+Cytidine- | Drug | Valproate: Week0-8: 300mg/day, Cytidine-: Week0-8: 2g/day |
|
| Valproate | Drug | Valproate: Week0-8: 300mg/day |
|
| Number of participants with adverse events | 8 weeks |
| Changes in brain phosphocreatine level assessed using magnetic resonance spectroscopy at baseline and 8 weeks | Baseline and at 8 weeks |
| D009930 |
| Organic Chemicals |
| D005232 | Fatty Acids, Volatile |
| D005227 | Fatty Acids |
| D008055 | Lipids |