NCT02625779

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.

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 Mar 2016

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withdrawn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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 7, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 9, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
1.2 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

1.2 years

First QC Date

December 7, 2015

Last Update Submit

February 8, 2018

Conditions

Depression, Bipolar

Keywords

Bipolar depressionCytidineCreatineMagnetic resonance spectroscopy

Outcome Measures

Primary Outcomes (2)

  • Change in symptoms of bipolar depression

    assessed with structured clinical interview

    Baseline and 8 weeks

  • Change in depressive symptoms

    assessed with structured clinical interview

    Baseline and 8 weeks

Secondary Outcomes (3)

  • Change in brain Glx (glutamate+glutamine) level

    Baseline and 8 weeks

  • Change in brain phosphocreatine level

    Baseline and 8 weeks

  • Number of participants with adverse events

    Baseline through 8 weeks

Study Arms (3)

Valproate and Placebo

ACTIVE COMPARATOR

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

Drug: Valproate and Placebo

Valproate and Cytidine-containing Drug

EXPERIMENTAL

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

Drug: Valproate and Cytidine-containing Drug

Valproate and Creatine-containing Drug

EXPERIMENTAL

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

Drug: Valproate and Creatine-containing Drug

Interventions

Valproate and PlaceboDRUG
Valproate and Placebo
Valproate and Cytidine-containing DrugDRUG
Valproate and Cytidine-containing Drug
Valproate and Creatine-containing DrugDRUG
Valproate and Creatine-containing Drug

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ewha Womans University Mokdong Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Valproic AcidCytidineCreatine

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Pentanoic AcidsValeratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty Acids, VolatileFatty AcidsLipidsPyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosidesGuanidinesAmidinesAmino AcidsAmino Acids, Peptides, and Proteins
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

December 7, 2015

First Posted

December 9, 2015

Study Start

March 1, 2016

Primary Completion

April 30, 2017

Study Completion

April 30, 2017

Last Updated

February 9, 2018

Record last verified: 2018-02

Locations

KR(1)