Cytidine- and Creatine-Containing Drug in Treating Bipolar Depression

Ewha Womans University

Status and phase: Withdrawn; Phase 2

Conditions: Bipolar Depression

Treatments: Drug: Valproate+Cytidine-+Creatine-; Drug: Valproate; Drug: Valproate+Cytidine-

Study type: Interventional

Funder types: Other

Identifiers

NCT01543139

EBI_bipolar2015

Details and patient eligibility

About

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.

Sex: All

Ages: 19 to 65 years old

Volunteers: No 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

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+Cytidine-+Creatine-

Experimental group

Description:

The subjects with bipolar depression, treated with cytidine- and creatine-containing drug and dietary supplement in addition to valproate

Treatment:

Drug: Valproate+Cytidine-+Creatine-

Valproate+Cytidine-

Active Comparator group

Description:

The subjects with bipolar depression, treated with cytidine-containing drug and dietary supplement in addition to valproate

Treatment:

Drug: Valproate+Cytidine-

Valproate

Active Comparator group

Description:

The subjects with bipolar depression, treated with valproate

Treatment:

Drug: Valproate