Cytidine- and Creatine-Containing Drug in Treating Bipolar Depression

February 8, 2018 updated by: In Kyoon Lyoo, Ewha Womans University

A Double-Blind, Placebo-Controlled Trial of Combined Cytidine- and Creatine-Containing Drug and Dietary Supplement in the Treatment of the Bipolar Depression

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 158-710
        • Ewha womans university medical center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in depressive symptom scores at 4 weeks
Time Frame: Baseline and at 4 weeks
Baseline and at 4 weeks
Change from baseline in depressive symptom scores at 8 weeks
Time Frame: Baseline and at 8 weeks
Baseline and at 8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in brain Glx (glutamate+glutamine) level assessed using magnetic resonance spectroscopy at baseline and 8 weeks
Time Frame: Baseline and at 8 weeks
Baseline and at 8 weeks
Number of participants with adverse events
Time Frame: 4 weeks
4 weeks
Number of participants with adverse events
Time Frame: 8 weeks
8 weeks
Changes in brain phosphocreatine level assessed using magnetic resonance spectroscopy at baseline and 8 weeks
Time Frame: Baseline and at 8 weeks
Baseline and at 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ewha Womans University

Investigators

  • Principal Investigator: In Kyoon Lyoo, MD, PhD, MMS, Ewha Womans University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2015

Primary Completion (Anticipated)

April 30, 2017

Study Completion (Anticipated)

April 30, 2017

Study Registration Dates

First Submitted

February 27, 2012

First Submitted That Met QC Criteria

February 27, 2012

First Posted (Estimate)

March 2, 2012

Study Record Updates

Last Update Posted (Actual)

February 9, 2018

Last Update Submitted That Met QC Criteria

February 8, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EBI_bipolar2015

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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