Cytidine- and Creatine-Containing Drug in Treating Bipolar Depression

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

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01543139

Enrollment

Registered

2012-03-02

Start date

2015-12-01

Completion date

2017-04-30

Last updated

2018-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Depression

Keywords

Bipolar Depression, Magnetic resonance spectroscopy, Cytidine-, Creatine-

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.

Interventions

DRUGValproate+Cytidine-+Creatine-

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

DRUGValproate+Cytidine-

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

DRUGValproate

Valproate: Week0-8: 300mg/day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

19 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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
Changes in brain phosphocreatine level assessed using magnetic resonance spectroscopy at baseline and 8 weeks	Baseline and at 8 weeks

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026