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Combined Cytidine and Creatine-containing Drug in the Treatment of the Bipolar Depression

Primary Purpose

Depression, Bipolar

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Withdrawn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

About this trial

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

Eligibility Criteria

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

Inclusion Criteria:

  • Aged 19-65 years
  • Bipolar disorder I or II (DSM-IV-TR) with current depressive episode
  • Informed consent

Exclusion Criteria:

  • Use of medication for bipolar depression or other psychotropic drugs
  • 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

Sites / Locations

  • Ewha Womans University Mokdong Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Valproate and Placebo

Valproate and Cytidine-containing Drug

Valproate and Creatine-containing Drug

Arm Description

Valproate: 300mg/day for 8 weeks Placebo: for 8 weeks

Valproate: 300mg/day for 8 weeks Cytidine-containing Drug: 2g/day for 8 weeks

Valproate: 300mg/day for 8 weeks Creatine-containing Drug: 3g/day for the first week 5g/day for week 2-8

Outcomes

Primary Outcome Measures

Change in symptoms of bipolar depression
assessed with structured clinical interview
Change in depressive symptoms
assessed with structured clinical interview

Secondary Outcome Measures

Change in brain Glx (glutamate+glutamine) level
assessed with proton magnetic resonance spectroscopy
Change in brain phosphocreatine level
assessed with phosphorous magnetic resonance spectroscopy
Number of participants with adverse events

Full Information

First Posted
December 7, 2015
Last Updated
February 8, 2018
Sponsor
Ewha Womans University Mokdong Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02625779
Brief Title
Combined Cytidine and Creatine-containing Drug in the Treatment of the 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
March 1, 2016 (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 Mokdong Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This research is aimed to investigate the efficacy and safety of the creatine and cytidine augmentation in treating bipolar depression and to evaluate changes in relevant brain biochemical metabolism using proton and phosphorous magnetic resonance spectroscopy.

6. Conditions and Keywords

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

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 and Placebo
Arm Type
Active Comparator
Arm Description
Valproate: 300mg/day for 8 weeks Placebo: for 8 weeks
Arm Title
Valproate and Cytidine-containing Drug
Arm Type
Experimental
Arm Description
Valproate: 300mg/day for 8 weeks Cytidine-containing Drug: 2g/day for 8 weeks
Arm Title
Valproate and Creatine-containing Drug
Arm Type
Experimental
Arm Description
Valproate: 300mg/day for 8 weeks Creatine-containing Drug: 3g/day for the first week 5g/day for week 2-8
Intervention Type
Drug
Intervention Name(s)
Valproate and Placebo
Intervention Type
Drug
Intervention Name(s)
Valproate and Cytidine-containing Drug
Intervention Type
Drug
Intervention Name(s)
Valproate and Creatine-containing Drug
Primary Outcome Measure Information:
Title
Change in symptoms of bipolar depression
Description
assessed with structured clinical interview
Time Frame
Baseline and 8 weeks
Title
Change in depressive symptoms
Description
assessed with structured clinical interview
Time Frame
Baseline and 8 weeks
Secondary Outcome Measure Information:
Title
Change in brain Glx (glutamate+glutamine) level
Description
assessed with proton magnetic resonance spectroscopy
Time Frame
Baseline and 8 weeks
Title
Change in brain phosphocreatine level
Description
assessed with phosphorous magnetic resonance spectroscopy
Time Frame
Baseline and 8 weeks
Title
Number of participants with adverse events
Time Frame
Baseline through 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: Aged 19-65 years Bipolar disorder I or II (DSM-IV-TR) with current depressive episode Informed consent Exclusion Criteria: Use of medication for bipolar depression or other psychotropic drugs 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
Facility Information:
Facility Name
Ewha Womans University Mokdong Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Combined Cytidine and Creatine-containing Drug in the Treatment of the Bipolar Depression

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