Cytidine- and Creatine-Containing Drug in Treating Bipolar Depression
NCT ID: NCT01543139
Last Updated: 2018-02-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2015-12-01
2017-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Valproate+Cytidine-+Creatine-
The subjects with bipolar depression, treated with cytidine- and creatine-containing drug and dietary supplement in addition to valproate
Valproate+Cytidine-+Creatine-
Valproate: Week0-8: 300mg/day, Cytidine-: Week0-8: 2g/day, Creatine-: Week0-1: 3g/day Week1-8: 5g/day
Valproate+Cytidine-
The subjects with bipolar depression, treated with cytidine-containing drug and dietary supplement in addition to valproate
Valproate+Cytidine-
Valproate: Week0-8: 300mg/day, Cytidine-: Week0-8: 2g/day
Valproate
The subjects with bipolar depression, treated with valproate
Valproate
Valproate: Week0-8: 300mg/day
Interventions
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Valproate+Cytidine-+Creatine-
Valproate: Week0-8: 300mg/day, Cytidine-: Week0-8: 2g/day, Creatine-: Week0-1: 3g/day Week1-8: 5g/day
Valproate+Cytidine-
Valproate: Week0-8: 300mg/day, Cytidine-: Week0-8: 2g/day
Valproate
Valproate: Week0-8: 300mg/day
Eligibility Criteria
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Inclusion Criteria
* Bipolar depression diagnosed by Structured Clinical Interview for DSM-IV (SCID-IV)
* Written informed consent
Exclusion Criteria
* Use of psychoactive medication that may affect brain imaging findings
* Diagnosis of any other axis I psychiatric disorder
* Presence of borderline personality disorder or antisocial personality disorder
* Presence of any major physical or neurological illness (e.g., epilepsy, multiple sclerosis, brain tumor, cerebrovascular disease, etc.)
* Hypersensitivity to divalproate, valpromide or diagnosis of porphyria
* Past or current liver disease, current severe liver or pancreas dysfunction
* Currently taking mefloquine
* Presence of alcohol or drug dependence, drug abuse
* Intelligence quotient below 80
* Contraindications to magnetic resonance imaging
* Women who are pregnant, breastfeeding, or planning pregnancy
* Allergy or intolerance to the study drugs
19 Years
65 Years
ALL
No
Sponsors
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Ewha Womans University
OTHER
Responsible Party
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In Kyoon Lyoo
Professor
Principal Investigators
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In Kyoon Lyoo, MD, PhD, MMS
Role: PRINCIPAL_INVESTIGATOR
Ewha Womans University
Locations
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Ewha Womans University Medical Center
Seoul, , South Korea
Countries
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Other Identifiers
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EBI_bipolar2015
Identifier Type: -
Identifier Source: org_study_id
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