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

• Status: Withdrawn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

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.

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

Details

• Lead Sponsor: Ewha Womans University Mokdong Hospital
• Treatments: Valproic Acid

Criteria

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