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

Phase 2

Withdrawn

• Conditions: Depression, Bipolar
• Interventions: Drug: Valproate and Creatine-containing Drug; Drug: Valproate and Cytidine-containing Drug; Drug: Valproate and Placebo

• Registration Number: NCT02625779
• Lead Sponsor: Ewha Womans University Mokdong Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-12-07
• Study First Submitted QC: 2015-12-07
• Study First Posted: 2015-12-09
• Study Start: 2016-03-01
• 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• Status: WITHDRAWN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

• Aged 19-65 years
• Bipolar disorder I or II (DSM-IV-TR) with current depressive episode
• Informed consent

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Valproate and Creatine-containing Drug	Valproate and Creatine-containing Drug	Valproate: 300mg/day for 8 weeks Creatine-containing Drug: 3g/day for the first week 5g/day for week 2-8
Valproate and Cytidine-containing Drug	Valproate and Cytidine-containing Drug	Valproate: 300mg/day for 8 weeks Cytidine-containing Drug: 2g/day for 8 weeks
Valproate and Placebo	Valproate and Placebo	Valproate: 300mg/day for 8 weeks Placebo: for 8 weeks

Primary Outcome Measures

Name	Time	Method
Change in depressive symptoms	Baseline and 8 weeks	assessed with structured clinical interview
Change in symptoms of bipolar depression	Baseline and 8 weeks	assessed with structured clinical interview

Secondary Outcome Measures

Name	Time	Method
Change in brain Glx (glutamate+glutamine) level	Baseline and 8 weeks	assessed with proton magnetic resonance spectroscopy
Change in brain phosphocreatine level	Baseline and 8 weeks	assessed with phosphorous magnetic resonance spectroscopy
Number of participants with adverse events	Baseline through 8 weeks

Trial Locations

Locations (1)

Ewha Womans University Mokdong Hospital; 🇰🇷 Seoul, Korea, Republic of