Combined Cytidine and Creatine-containing Drug in the Treatment of the Bipolar Depression
NCT ID: NCT02625779
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WITHDRAWN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
2016-03-01
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 and Placebo
Valproate: 300mg/day for 8 weeks Placebo: for 8 weeks
Valproate and Placebo
Valproate and Cytidine-containing Drug
Valproate: 300mg/day for 8 weeks Cytidine-containing Drug: 2g/day for 8 weeks
Valproate and Cytidine-containing Drug
Valproate and Creatine-containing Drug
Valproate: 300mg/day for 8 weeks Creatine-containing Drug: 3g/day for the first week 5g/day for week 2-8
Valproate and Creatine-containing Drug
Interventions
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Valproate and Placebo
Valproate and Cytidine-containing Drug
Valproate and Creatine-containing Drug
Eligibility Criteria
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Inclusion Criteria
* Bipolar disorder I or II (DSM-IV-TR) with current depressive episode
* Informed consent
Exclusion Criteria
* Current Axis I mental disorders other than bipolar depression based on structured clinical interview
* Current borderline or antisocial personality disorder based on structured clinical interview
* Major medical or neurological illnesses (epilepsy, multiple sclerosis, brain tumor, cerebrovascular disease, etc)
* Hypersensitivity to divalproate or valpromide
* Diagnosis of porphyria
* Current or past liver diseases
* Severe dysfunction in liver or pancreas
* Use of mefloquine
* Alcohol or substance abuse/dependence
* Intelligence quotient of 80 or below
* Contraindications to magnetic resonance imaging
* Pregnancy or breastfeeding
* Allergy or intolerance to the study drugs
19 Years
65 Years
ALL
No
Sponsors
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Ewha Womans University Mokdong Hospital
OTHER
Responsible Party
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In Kyoon Lyoo
Professor
Locations
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Ewha Womans University Mokdong Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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NARSAD_Bipolar
Identifier Type: -
Identifier Source: org_study_id
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