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

Ewha Womans University Mokdong Hospital

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Conditions

Depression, Bipolar

Interventions

Valproate and PlaceboDRUG

Valproate and Cytidine-containing DrugDRUG

Valproate and Creatine-containing DrugDRUG

Eligibility

Sex: ALLMin age: 19 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Ewha Womans University Mokdong Hospital

Seoul, South Korea

Outcomes

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

Data from ClinicalTrials.gov

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