Cytidine- and Creatine-Containing Drug in Treating Bipolar Depression

Bipolar Depression Clinical Trial

Official title:

A Double-Blind, Placebo-Controlled Trial of Combined Cytidine- and Creatine-Containing Drug and Dietary Supplement in the Treatment of the Bipolar Depression

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01543139
• Other study ID #: EBI_bipolar2015
• Status: Withdrawn
• Phase: Phase 2
• First received: February 27, 2012
• Last updated: February 8, 2018
• Start date: December 1, 2015
• Est. completion date: April 30, 2017

Study information

• Verified date: February 2018
• Source: Ewha Womans University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 30, 2017
• Est. primary completion date: April 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Depression
• Bipolar Disorder
• Depression
• Depressive Disorder

Intervention

Drug:
• Valproate+Cytidine-+Creatine-
Valproate: Week0-8: 300mg/day, Cytidine-: Week0-8: 2g/day, Creatine-: Week0-1: 3g/day Week1-8: 5g/day
• Valproate+Cytidine-
Valproate: Week0-8: 300mg/day, Cytidine-: Week0-8: 2g/day
• Valproate
Valproate: Week0-8: 300mg/day

Locations

Country	Name	City	State
Korea, Republic of	Ewha Womans University Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Ewha Womans University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in depressive symptom scores at 4 weeks		Baseline and at 4 weeks
Primary	Change from baseline in depressive symptom scores at 8 weeks		Baseline and at 8 weeks
Secondary	Changes in brain Glx (glutamate+glutamine) level assessed using magnetic resonance spectroscopy at baseline and 8 weeks		Baseline and at 8 weeks
Secondary	Number of participants with adverse events		4 weeks
Secondary	Number of participants with adverse events		8 weeks
Secondary	Changes in brain phosphocreatine level assessed using magnetic resonance spectroscopy at baseline and 8 weeks		Baseline and at 8 weeks