search
Back to results

Cytidine- and Creatine-Containing Drug in Treating Bipolar Depression

Primary Purpose

Bipolar Depression

Status
Withdrawn
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Valproate+Cytidine-+Creatine-
Valproate+Cytidine-
Valproate
Sponsored by
Ewha Womans University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Depression focused on measuring Bipolar Depression, Magnetic resonance spectroscopy, Cytidine-, Creatine-

Eligibility Criteria

19 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ewha Womans University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Valproate+Cytidine-+Creatine-

Valproate+Cytidine-

Valproate

Arm Description

The subjects with bipolar depression, treated with cytidine- and creatine-containing drug and dietary supplement in addition to valproate

The subjects with bipolar depression, treated with cytidine-containing drug and dietary supplement in addition to valproate

The subjects with bipolar depression, treated with valproate

Outcomes

Primary Outcome Measures

Change from baseline in depressive symptom scores at 4 weeks
Change from baseline in depressive symptom scores at 8 weeks

Secondary Outcome Measures

Changes in brain Glx (glutamate+glutamine) level assessed using magnetic resonance spectroscopy at baseline and 8 weeks
Number of participants with adverse events
Number of participants with adverse events
Changes in brain phosphocreatine level assessed using magnetic resonance spectroscopy at baseline and 8 weeks

Full Information

First Posted
February 27, 2012
Last Updated
February 8, 2018
Sponsor
Ewha Womans University
search

1. Study Identification

Unique Protocol Identification Number
NCT01543139
Brief Title
Cytidine- and Creatine-Containing Drug in Treating Bipolar Depression
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Withdrawn
Why Stopped
The research project has been cancelled before any participants were enrolled.
Study Start Date
December 1, 2015 (Anticipated)
Primary Completion Date
April 30, 2017 (Anticipated)
Study Completion Date
April 30, 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ewha Womans University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Depression
Keywords
Bipolar Depression, Magnetic resonance spectroscopy, Cytidine-, Creatine-

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Valproate+Cytidine-+Creatine-
Arm Type
Experimental
Arm Description
The subjects with bipolar depression, treated with cytidine- and creatine-containing drug and dietary supplement in addition to valproate
Arm Title
Valproate+Cytidine-
Arm Type
Active Comparator
Arm Description
The subjects with bipolar depression, treated with cytidine-containing drug and dietary supplement in addition to valproate
Arm Title
Valproate
Arm Type
Active Comparator
Arm Description
The subjects with bipolar depression, treated with valproate
Intervention Type
Drug
Intervention Name(s)
Valproate+Cytidine-+Creatine-
Intervention Description
Valproate: Week0-8: 300mg/day, Cytidine-: Week0-8: 2g/day, Creatine-: Week0-1: 3g/day Week1-8: 5g/day
Intervention Type
Drug
Intervention Name(s)
Valproate+Cytidine-
Intervention Description
Valproate: Week0-8: 300mg/day, Cytidine-: Week0-8: 2g/day
Intervention Type
Drug
Intervention Name(s)
Valproate
Intervention Description
Valproate: Week0-8: 300mg/day
Primary Outcome Measure Information:
Title
Change from baseline in depressive symptom scores at 4 weeks
Time Frame
Baseline and at 4 weeks
Title
Change from baseline in depressive symptom scores at 8 weeks
Time Frame
Baseline and at 8 weeks
Secondary Outcome Measure Information:
Title
Changes in brain Glx (glutamate+glutamine) level assessed using magnetic resonance spectroscopy at baseline and 8 weeks
Time Frame
Baseline and at 8 weeks
Title
Number of participants with adverse events
Time Frame
4 weeks
Title
Number of participants with adverse events
Time Frame
8 weeks
Title
Changes in brain phosphocreatine level assessed using magnetic resonance spectroscopy at baseline and 8 weeks
Time Frame
Baseline and at 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
In Kyoon Lyoo, MD, PhD, MMS
Organizational Affiliation
Ewha Womans University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ewha Womans University Medical Center
City
Seoul
ZIP/Postal Code
158-710
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Cytidine- and Creatine-Containing Drug in Treating Bipolar Depression

We'll reach out to this number within 24 hrs