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

February 8, 2018 updated by: In Kyoon Lyoo, Ewha Womans University Mokdong Hospital

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Valproate and Placebo
Valproate: 300mg/day for 8 weeks Placebo: for 8 weeks
Drug: Valproate and Placebo
Experimental: Valproate and Cytidine-containing Drug
Valproate: 300mg/day for 8 weeks Cytidine-containing Drug: 2g/day for 8 weeks
Drug: Valproate and Cytidine-containing Drug
Experimental: 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
Drug: Valproate and Creatine-containing Drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in symptoms of bipolar depression
Time Frame: Baseline and 8 weeks
assessed with structured clinical interview
Baseline and 8 weeks
Change in depressive symptoms
Time Frame: Baseline and 8 weeks
assessed with structured clinical interview
Baseline and 8 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ewha Womans University Mokdong Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2016

Primary Completion (Anticipated)

April 30, 2017

Study Completion (Anticipated)

April 30, 2017

Study Registration Dates

First Submitted

December 7, 2015

First Submitted That Met QC Criteria

December 7, 2015

First Posted (Estimate)

December 9, 2015

Study Record Updates

Last Update Posted (Actual)

February 9, 2018

Last Update Submitted That Met QC Criteria

February 8, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NARSAD_Bipolar

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

3
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