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Cytidine- and Creatine-Containing Drug in Treating Bipolar Depression

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ClinicalTrials.gov Identifier: NCT01543139
Recruitment Status : Withdrawn (The research project has been cancelled before any participants were enrolled.)
First Posted : March 2, 2012
Last Update Posted : February 9, 2018
Sponsor:
Information provided by (Responsible Party):
In Kyoon Lyoo, Ewha Womans University

Tracking Information
First Submitted Date  ICMJE February 27, 2012
First Posted Date  ICMJE March 2, 2012
Last Update Posted Date February 9, 2018
Estimated Study Start Date  ICMJE December 1, 2015
Estimated Primary Completion Date April 30, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 8, 2018)
  • Change from baseline in depressive symptom scores at 4 weeks [ Time Frame: Baseline and at 4 weeks ]
  • Change from baseline in depressive symptom scores at 8 weeks [ Time Frame: Baseline and at 8 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 27, 2012)
  • Change from baseline in depressive symptom scores at 12 weeks [ Time Frame: Baseline and at 12 weeks ]
  • Change from baseline in depressive symptom scores at 8 weeks [ Time Frame: Baseline and at 8 weeks ]
  • Change from baseline in depressive symptom scores at 4 weeks [ Time Frame: Baseline and at 4 weeks ]
  • Change from baseline in depressive symptom scores at 1 week [ Time Frame: Baseline and at 1 week ]
  • Change from baseline in manic symptom scores at 1 week [ Time Frame: Baseline and at 1 week ]
  • Change from baseline in manic symptom scores at 4 weeks [ Time Frame: Baseline and at 4 weeks ]
  • Change from baseline in manic symptom scores at 8 weeks [ Time Frame: Baseline and at 8 weeks ]
  • Change from baseline in manic symptom scores at 12 weeks [ Time Frame: Baseline and at 12 weeks ]
  • Change from baseline in global function scores at 1 week [ Time Frame: Baseline and at 1 week ]
  • Change from baseline in global function scores at 4 weeks [ Time Frame: Baseline and at 4 weeks ]
  • Change from baseline in global function scores at 8 weeks [ Time Frame: Baseline and at 8 weeks ]
  • Change from baseline in global function scores at 12 weeks [ Time Frame: Baseline and at 12 weeks ]
Change History Complete list of historical versions of study NCT01543139 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 8, 2018)
  • Changes in brain Glx (glutamate+glutamine) level assessed using magnetic resonance spectroscopy at baseline and 8 weeks [ Time Frame: Baseline and at 8 weeks ]
  • Number of participants with adverse events [ Time Frame: 4 weeks ]
  • Number of participants with adverse events [ Time Frame: 8 weeks ]
  • Changes in brain phosphocreatine level assessed using magnetic resonance spectroscopy at baseline and 8 weeks [ Time Frame: Baseline and at 8 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 27, 2012)
  • Changes from baseline in brain structure, function, and biochemical metabolism, analyzed using the computational approach [ Time Frame: Baseline and at 12 weeks ]
  • Number of participants with adverse events [ Time Frame: 1 week ]
  • Number of participants with adverse events [ Time Frame: 4 weeks ]
  • Number of participants with adverse events [ Time Frame: 8 weeks ]
  • Number of participants with adverse events [ Time Frame: 12 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cytidine- and Creatine-Containing Drug in Treating Bipolar Depression
Official Title  ICMJE A Double-Blind, Placebo-Controlled Trial of Combined Cytidine- and Creatine-Containing Drug and Dietary Supplement in the Treatment of the Bipolar Depression
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Bipolar Depression
Intervention  ICMJE
  • Drug: Valproate+Cytidine-+Creatine-
    Valproate: Week0-8: 300mg/day, Cytidine-: Week0-8: 2g/day, Creatine-: Week0-1: 3g/day Week1-8: 5g/day
  • Drug: Valproate+Cytidine-
    Valproate: Week0-8: 300mg/day, Cytidine-: Week0-8: 2g/day
  • Drug: Valproate
    Valproate: Week0-8: 300mg/day
Study Arms  ICMJE
  • Experimental: Valproate+Cytidine-+Creatine-
    The subjects with bipolar depression, treated with cytidine- and creatine-containing drug and dietary supplement in addition to valproate
    Intervention: Drug: Valproate+Cytidine-+Creatine-
  • Active Comparator: Valproate+Cytidine-
    The subjects with bipolar depression, treated with cytidine-containing drug and dietary supplement in addition to valproate
    Intervention: Drug: Valproate+Cytidine-
  • Active Comparator: Valproate
    The subjects with bipolar depression, treated with valproate
    Intervention: Drug: Valproate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: February 8, 2018)
0
Original Estimated Enrollment  ICMJE
 (submitted: February 27, 2012)
75
Estimated Study Completion Date  ICMJE April 30, 2017
Estimated Primary Completion Date April 30, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 19-65 year-old male or female
  • Bipolar depression diagnosed by Structured Clinical Interview for DSM-IV (SCID-IV)
  • Written informed consent

Exclusion Criteria:

  • Present use of drugs for bipolar depression or any psychotropic medication
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01543139
Other Study ID Numbers  ICMJE EBI_bipolar2015
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party In Kyoon Lyoo, Ewha Womans University
Study Sponsor  ICMJE Ewha Womans University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: In Kyoon Lyoo, MD, PhD, MMS Ewha Womans University
PRS Account Ewha Womans University
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP