Cytidine- and Creatine-Containing Drug in Treating Bipolar Depression

Study Overview
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Brief Summary
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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.

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

Conditions
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Bipolar Depression

Intervention / Treatment
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* Drug: Valproate+Cytidine-+Creatine-
* Drug: Valproate+Cytidine-
* Drug: Valproate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bipolar Depression, Magnetic resonance spectroscopy, Cytidine-, Creatine-