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

Ewha Womans University

Status and phase: Withdrawn; Phase 2

Conditions: Depression, Bipolar

Treatments: Drug: Valproate and Placebo; Drug: Valproate and Creatine-containing Drug; Drug: Valproate and Cytidine-containing Drug

Study type: Interventional

Funder types: Other

Identifiers

NCT02625779

NARSAD_Bipolar

Details and patient eligibility

About

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.

Sex: All

Ages: 19 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 3 patient groups

Valproate and Placebo

Active Comparator group

Description:

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

Treatment:

Drug: Valproate and Placebo

Valproate and Cytidine-containing Drug

Experimental group

Description:

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

Treatment:

Drug: Valproate and Cytidine-containing Drug

Valproate and Creatine-containing Drug

Experimental group

Description:

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

Treatment:

Drug: Valproate and Creatine-containing Drug