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

Depression, Bipolar 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Clinical Trial Details — Status: Withdrawn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: NCT02625779
• Other study ID #: NARSAD_Bipolar
• Status: Withdrawn
• Phase: Phase 2
• First received: December 7, 2015
• Last updated: February 8, 2018
• Start date: March 1, 2016
• Est. completion date: April 30, 2017

Study information

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

Clinical Trial 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.

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• Status: Withdrawn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:

• Aged 19-65 years

• Bipolar disorder I or II (DSM-IV-TR) with current depressive episode

• Informed consent

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

Related Conditions & MeSH terms

• Bipolar Disorder
• Depression
• Depression, Bipolar
• Depressive Disorder

Intervention

Drug:
• Valproate and Placebo

• Valproate and Cytidine-containing Drug

• Valproate and Creatine-containing Drug

Locations

Country	Name	City	State
Korea, Republic of	Ewha Womans University Mokdong Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Ewha Womans University Mokdong Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in symptoms of bipolar depression	assessed with structured clinical interview	Baseline and 8 weeks
Primary	Change in depressive symptoms	assessed with structured clinical interview	Baseline and 8 weeks
Secondary	Change in brain Glx (glutamate+glutamine) level	assessed with proton magnetic resonance spectroscopy	Baseline and 8 weeks
Secondary	Change in brain phosphocreatine level	assessed with phosphorous magnetic resonance spectroscopy	Baseline and 8 weeks
Secondary	Number of participants with adverse events		Baseline through 8 weeks