Cytidine- and Creatine-Containing Drug in Treating Bipolar Depression

Phase 2

Withdrawn

• Conditions: Bipolar Depression
• Interventions: Drug: Valproate+Cytidine-+Creatine-; Drug: Valproate+Cytidine-; Drug: Valproate

• Registration Number: NCT01543139
• Lead Sponsor: Ewha Womans University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-02-27
• Study First Submitted QC: 2012-02-27
• Study First Posted: 2012-03-02
• Study Start: 2015-12-01
• Primary Completion: 2017-04-30
• Study Completion: 2017-04-30
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-08
• Last Update Posted: 2018-02-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Valproate+Cytidine-+Creatine-	Valproate+Cytidine-+Creatine-	The subjects with bipolar depression, treated with cytidine- and creatine-containing drug and dietary supplement in addition to valproate
Valproate+Cytidine-	Valproate+Cytidine-	The subjects with bipolar depression, treated with cytidine-containing drug and dietary supplement in addition to valproate
Valproate	Valproate	The subjects with bipolar depression, treated with valproate

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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	8 weeks
Changes in brain phosphocreatine level assessed using magnetic resonance spectroscopy at baseline and 8 weeks	Baseline and at 8 weeks

Trial Locations

Locations (1)

Ewha Womans University Medical Center; 🇰🇷 Seoul, Korea, Republic of