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The research project has been cancelled before any participants were enrolled.
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This research is aimed to investigate the efficacy and safety of the creatine and cytidine augmentation in treating bipolar depression and to evaluate changes in relevant brain biochemical metabolism using proton and phosphorous magnetic resonance spectroscopy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Valproate and Placebo | Active Comparator | Valproate: 300mg/day for 8 weeks Placebo: for 8 weeks |
|
| Valproate and Cytidine-containing Drug | Experimental | Valproate: 300mg/day for 8 weeks Cytidine-containing Drug: 2g/day for 8 weeks |
|
| Valproate and Creatine-containing Drug | Experimental | Valproate: 300mg/day for 8 weeks Creatine-containing Drug: 3g/day for the first week 5g/day for week 2-8 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Valproate and Placebo | Drug |
| ||
| Valproate and Cytidine-containing Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Change in symptoms of bipolar depression | assessed with structured clinical interview | Baseline and 8 weeks |
| Change in depressive symptoms | assessed with structured clinical interview | Baseline and 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in brain Glx (glutamate+glutamine) level | assessed with proton magnetic resonance spectroscopy | Baseline and 8 weeks |
| Change in brain phosphocreatine level | assessed with phosphorous magnetic resonance spectroscopy |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ewha Womans University Mokdong Hospital | Seoul | 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 |
| D003562 | Cytidine |
| D003401 | Creatine |
| ID | Term |
|---|---|
| D010421 | Pentanoic Acids |
| D014631 | Valerates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
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| Drug |
|
| Valproate and Creatine-containing Drug | Drug |
|
| Baseline and 8 weeks |
| Number of participants with adverse events | Baseline through 8 weeks |
| D009930 |
| Organic Chemicals |
| D005232 | Fatty Acids, Volatile |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |