Cytidine- and Creatine-Containing Drug in Treating Bipolar Depression

• Status: Withdrawn
• Trial end date: 2017-04-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ewha Womans University; Seoul National University Hospital
• Treatments: Valproic Acid

Criteria

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