Cytidine- and Creatine-Containing Drug in Treating Bipolar Depression

Sponsor

Ewha Womans University (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01543139

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Bipolar Depression	Drug: Valproate+Cytidine-+Creatine- Drug: Valproate+Cytidine- Drug: Valproate	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Dec 1, 2015

Anticipated Primary Completion Date :

Apr 30, 2017

Anticipated Study Completion Date :

Apr 30, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Valproate+Cytidine-+Creatine- The subjects with bipolar depression, treated with cytidine- and creatine-containing drug and dietary supplement in addition to valproate	Drug: Valproate+Cytidine-+Creatine- Valproate: Week0-8: 300mg/day, Cytidine-: Week0-8: 2g/day, Creatine-: Week0-1: 3g/day Week1-8: 5g/day
Active Comparator: Valproate+Cytidine- The subjects with bipolar depression, treated with cytidine-containing drug and dietary supplement in addition to valproate	Drug: Valproate+Cytidine- Valproate: Week0-8: 300mg/day, Cytidine-: Week0-8: 2g/day
Active Comparator: Valproate The subjects with bipolar depression, treated with valproate	Drug: Valproate Valproate: Week0-8: 300mg/day

Arm

Intervention/Treatment

Experimental: Valproate+Cytidine-+Creatine-

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

Drug: Valproate+Cytidine-+Creatine-

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

Active Comparator: Valproate+Cytidine-

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

Drug: Valproate+Cytidine-

Valproate: Week0-8: 300mg/day, Cytidine-: Week0-8: 2g/day

Active Comparator: Valproate

The subjects with bipolar depression, treated with valproate

Drug: Valproate

Valproate: Week0-8: 300mg/day

Outcome Measures

Primary Outcome Measures

Change from baseline in depressive symptom scores at 4 weeks [Baseline and at 4 weeks]
Change from baseline in depressive symptom scores at 8 weeks [Baseline and at 8 weeks]

Secondary Outcome Measures

Changes in brain Glx (glutamate+glutamine) level assessed using magnetic resonance spectroscopy at baseline and 8 weeks [Baseline and at 8 weeks]
Number of participants with adverse events [4 weeks]
Number of participants with adverse events [8 weeks]
Changes in brain phosphocreatine level assessed using magnetic resonance spectroscopy at baseline and 8 weeks [Baseline and at 8 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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