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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Recruitment Status : Withdrawn (The research project has been cancelled before any participants were enrolled.)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

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.

Condition or disease Intervention/treatment Phase
Bipolar Depression Drug: Valproate+Cytidine-+Creatine- Drug: Valproate+Cytidine- Drug: Valproate Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled Trial of Combined Cytidine- and Creatine-Containing Drug and Dietary Supplement in the Treatment of the Bipolar Depression
Estimated Study Start Date : December 1, 2015
Estimated Primary Completion Date : April 30, 2017
Estimated Study Completion Date : April 30, 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Valproate+Cytidine-+Creatine-
The subjects with bipolar depression, treated with cytidine- and creatine-containing drug and dietary supplement in addition to valproate
Drug: Valproate+Cytidine-+Creatine-
Valproate: Week0-8: 300mg/day, Cytidine-: Week0-8: 2g/day, Creatine-: Week0-1: 3g/day Week1-8: 5g/day
Active Comparator: Valproate+Cytidine-
The subjects with bipolar depression, treated with cytidine-containing drug and dietary supplement in addition to valproate
Drug: Valproate+Cytidine-
Valproate: Week0-8: 300mg/day, Cytidine-: Week0-8: 2g/day
Active Comparator: Valproate
The subjects with bipolar depression, treated with valproate
Drug: Valproate
Valproate: Week0-8: 300mg/day



Primary Outcome Measures :
  1. Change from baseline in depressive symptom scores at 4 weeks [ Time Frame: Baseline and at 4 weeks ]
  2. Change from baseline in depressive symptom scores at 8 weeks [ Time Frame: Baseline and at 8 weeks ]

Secondary Outcome Measures :
  1. Changes in brain Glx (glutamate+glutamine) level assessed using magnetic resonance spectroscopy at baseline and 8 weeks [ Time Frame: Baseline and at 8 weeks ]
  2. Number of participants with adverse events [ Time Frame: 4 weeks ]
  3. Number of participants with adverse events [ Time Frame: 8 weeks ]
  4. Changes in brain phosphocreatine level assessed using magnetic resonance spectroscopy at baseline and 8 weeks [ Time Frame: Baseline and at 8 weeks ]


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Ages Eligible for Study:   19 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01543139


Locations
Korea, Republic of
Ewha Womans University Medical Center
Seoul, Korea, Republic of, 158-710
Sponsors and Collaborators
Ewha Womans University
Investigators
Principal Investigator: In Kyoon Lyoo, MD, PhD, MMS Ewha Womans University

Responsible Party: In Kyoon Lyoo, Professor, Ewha Womans University
ClinicalTrials.gov Identifier: NCT01543139     History of Changes
Other Study ID Numbers: EBI_bipolar2015
First Posted: March 2, 2012    Key Record Dates
Last Update Posted: February 9, 2018
Last Verified: February 2018

Keywords provided by In Kyoon Lyoo, Ewha Womans University:
Bipolar Depression
Magnetic resonance spectroscopy
Cytidine-
Creatine-

Additional relevant MeSH terms:
Depression
Depressive Disorder
Bipolar Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Bipolar and Related Disorders
Valproic Acid
Anticonvulsants
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs