NCT01543139

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2015

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 2, 2012

Completed
3.8 years until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2017

Completed
Last Updated

February 9, 2018

Status Verified

February 1, 2018

Enrollment Period

1.4 years

First QC Date

February 27, 2012

Last Update Submit

February 8, 2018

Conditions

Bipolar Depression

Keywords

Bipolar DepressionMagnetic resonance spectroscopyCytidine-Creatine-

Outcome Measures

Primary Outcomes (2)

  • Change from baseline in depressive symptom scores at 4 weeks

    Baseline and at 4 weeks

  • Change from baseline in depressive symptom scores at 8 weeks

    Baseline and at 8 weeks

Secondary Outcomes (4)

  • Changes in brain Glx (glutamate+glutamine) level assessed using magnetic resonance spectroscopy at baseline and 8 weeks

    Baseline and at 8 weeks

  • Number of participants with adverse events

    4 weeks

  • Number of participants with adverse events

    8 weeks

  • Changes in brain phosphocreatine level assessed using magnetic resonance spectroscopy at baseline and 8 weeks

    Baseline and at 8 weeks

Study Arms (3)

Valproate+Cytidine-+Creatine-

EXPERIMENTAL

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

Drug: Valproate+Cytidine-+Creatine-

Valproate+Cytidine-

ACTIVE COMPARATOR

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

Drug: Valproate+Cytidine-

Valproate

ACTIVE COMPARATOR

The subjects with bipolar depression, treated with valproate

Drug: Valproate

Interventions

Valproate+Cytidine-+Creatine-DRUG

Valproate: Week0-8: 300mg/day, Cytidine-: Week0-8: 2g/day, Creatine-: Week0-1: 3g/day Week1-8: 5g/day

Valproate+Cytidine-+Creatine-
Valproate+Cytidine-DRUG

Valproate: Week0-8: 300mg/day, Cytidine-: Week0-8: 2g/day

Valproate+Cytidine-
ValproateDRUG

Valproate: Week0-8: 300mg/day

Valproate

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ewha Womans University Medical Center

Seoul, 158-710, South Korea

Location

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Valproic Acid

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Pentanoic AcidsValeratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty Acids, VolatileFatty AcidsLipids

Study Officials

  • In Kyoon Lyoo, MD, PhD, MMS

    Ewha Womans University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 27, 2012

First Posted

March 2, 2012

Study Start

December 1, 2015

Primary Completion

April 30, 2017

Study Completion

April 30, 2017

Last Updated

February 9, 2018

Record last verified: 2018-02

Locations

KR(1)