Combined Cytidine and Creatine-containing Drug in the Treatment of the 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Withdrawn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

NCT02625779

Enrollment

Registered

2015-12-09

Start date

2016-03-01

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

Depression, Bipolar

Keywords

Bipolar depression, Cytidine, Creatine, Magnetic resonance spectroscopy

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.

Interventions

DRUGValproate and Placebo

DRUGValproate and Cytidine-containing Drug

DRUGValproate and Creatine-containing Drug

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

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

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

Design outcomes

Primary

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

Secondary

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

Countries

South Korea

Outcome results

None listed

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