WithdrawnNCT02625779Updated Feb 9, 2018

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

A Phase 2 interventional study of Valproate and Placebo and Valproate and Cytidine-containing Drug in Depression, Bipolar, sponsored by Ewha Womans University Mokdong Hospital. Withdrawn at 1 site in South Korea. Open to participants aged 19 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-02-09.

Sponsored by Ewha Womans University Mokdong Hospital · Phase 2, Interventional, and Treatment

Why this study was withdrawn

The research project has been cancelled before any participants were enrolled.

Phase: Phase 2
Study type: Interventional
Enrollment: 0
Allocation: Randomized
Ages: 19 Years to 65 Years
Sex: All

Study 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.

Conditions studied

Depression, Bipolar

Browse trials for

Bipolar Disorder 1,637

Keywords

Bipolar depression
Cytidine
Creatine
Magnetic resonance spectroscopy

In context

Bipolar Disorder

1,637 studies on the registry are indexed under Bipolar Disorder; 258 are open to participants now.

Browse Bipolar Disorder studies →

Lead sponsor

Ewha Womans University Mokdong Hospital is the lead sponsor of 28 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 19 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 0 participants (actual)

Study arms

Active comparator
Valproate and Placebo
Valproate: 300mg/day for 8 weeks Placebo: for 8 weeks
Drug: Valproate and Placebo
Experimental
Valproate and Cytidine-containing Drug
Valproate: 300mg/day for 8 weeks Cytidine-containing Drug: 2g/day for 8 weeks
Drug: Valproate and Cytidine-containing Drug
Experimental
Valproate and Creatine-containing Drug
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

DrugValproate and Placebo
DrugValproate and Cytidine-containing Drug
DrugValproate and Creatine-containing Drug

What researchers measure

Primary outcomes

Change in symptoms of bipolar depression
assessed with structured clinical interview
Time frame: Baseline and 8 weeks
Change in depressive symptoms
assessed with structured clinical interview
Time frame: Baseline and 8 weeks

Secondary outcomes

Change in brain Glx (glutamate+glutamine) level
assessed with proton magnetic resonance spectroscopy
Time frame: Baseline and 8 weeks
Change in brain phosphocreatine level
assessed with phosphorous magnetic resonance spectroscopy
Time frame: Baseline and 8 weeks
Number of participants with adverse events
Time frame: Baseline through 8 weeks

Study locations

1 site

Ewha Womans University Mokdong Hospital
Seoul, South Korea

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Start is estimated for Mar 2016; primary completion for Apr 2017, 13 months later.

How these figures are worked out, and which studies are left out of them.

Registered: Dec 7, 2015
First posted: Dec 9, 2015
StartEst.: Mar 1, 2016
Primary completionEst.: Apr 30, 2017
CompletionEst.: Apr 30, 2017
Last update: Feb 9, 2018

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Feb 9, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02625779
Lead sponsor: Ewha Womans University Mokdong Hospital
Responsible party: In Kyoon Lyoo (Professor, Ewha Womans University Mokdong Hospital) — Principal investigator
First posted: Dec 9, 2015
Start date: Mar 1, 2016 (estimated)
Primary completion: Apr 30, 2017 (estimated)
Completion: Apr 30, 2017 (estimated)
Last update: Feb 9, 2018

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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