Trial of Combined Cytidine and Creatine in the Treatment of the Bipolar Depression

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Seoul National University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
In Kyoon Lyoo, MD, PhD, MMS, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01543139
First received: February 27, 2012
Last updated: June 6, 2012
Last verified: June 2012
  Purpose

This proposed 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 magnetic resonance spectroscopy.


Condition Intervention
Bipolar Disorder
Dietary Supplement: Valproate+Cytidine+Creatine
Dietary Supplement: Valproate+Cytidine
Drug: Valproate

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled Trial of Combined Cytidine and Creatine in the Treatment of the Bipolar Depression: A Magnetic Resonance Spectroscopy Study

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Change from baseline in depressive symptom scores at 12 weeks [ Time Frame: Baseline and at 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in depressive symptom scores at 8 weeks [ Time Frame: Baseline and at 8 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in depressive symptom scores at 4 weeks [ Time Frame: Baseline and at 4 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in depressive symptom scores at 1 week [ Time Frame: Baseline and at 1 week ] [ Designated as safety issue: No ]
  • Change from baseline in manic symptom scores at 1 week [ Time Frame: Baseline and at 1 week ] [ Designated as safety issue: No ]
  • Change from baseline in manic symptom scores at 4 weeks [ Time Frame: Baseline and at 4 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in manic symptom scores at 8 weeks [ Time Frame: Baseline and at 8 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in manic symptom scores at 12 weeks [ Time Frame: Baseline and at 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in global function scores at 1 week [ Time Frame: Baseline and at 1 week ] [ Designated as safety issue: No ]
  • Change from baseline in global function scores at 4 weeks [ Time Frame: Baseline and at 4 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in global function scores at 8 weeks [ Time Frame: Baseline and at 8 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in global function scores at 12 weeks [ Time Frame: Baseline and at 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes from baseline in brain structure, function, and biochemical metabolism, analyzed using the computational approach [ Time Frame: Baseline and at 12 weeks ] [ Designated as safety issue: No ]
  • Number of participants with adverse events [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
  • Number of participants with adverse events [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
  • Number of participants with adverse events [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • Number of participants with adverse events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 75
Study Start Date: October 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Valproate+Cytidine+Creatine Dietary Supplement: Valproate+Cytidine+Creatine
Valproate: 300mg/day, Cytidine: 1g every other day, Creatine: Week0-1: 3g/day Week1-12: 5g/day
Active Comparator: Valproate+Cytidine Dietary Supplement: Valproate+Cytidine
Valproate: 300mg/day, Cytidine: 1g every other day
Active Comparator: Valproate Drug: Valproate
Valproate: 300mg/day

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women aged between 18 and 65
  • Diagnosis of bipolar depression as assessed by the Structured Clinical Interview for DSM-IV (SCID-IV)
  • Individuals who provided written consent for participation

Exclusion Criteria:

  • Present or past use of drugs for bipolar depression
  • Presence of any major physical or neurological illness (e.g., head trauma, epilepsy, seizure, stroke, cerebral tumor, multiple sclerosis, cerebrovascular disease, narrow-angle glaucoma, drug hypersensitivity, etc.)
  • Diagnosis of any Axis I disorder other than bipolar disorder or presence of symptoms requiring hospitalization
  • Presence of borderline personality disorder or antisocial personality disorder
  • Presence of alcohol or drug dependence
  • Intelligence quotient below 80
  • Contraindications to magnetic resonance imaging (e.g., pacemaker implantation, claustrophobia, etc.)
  • Use of psychoactive medications that may affect brain imaging findings
  • Women who are pregnant, breastfeeding, or planning pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01543139

Contacts
Contact: Junghyun H Lee, MD, MS 82-10-3453-1744 leejunghyun1@gmail.com

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Jeong-Hwa Hong, MD    82-2-740-8096    jhhong@snu.ac.kr   
Principal Investigator: In Kyoon Lyoo, MD, PhD, MMS         
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: In Kyoon Lyoo, MD, PhD, MMS Seoul National University Hospital
  More Information

No publications provided

Responsible Party: In Kyoon Lyoo, MD, PhD, MMS, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01543139     History of Changes
Other Study ID Numbers: bpcre2009
Study First Received: February 27, 2012
Last Updated: June 6, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Depression
Bipolar Disorder
Behavioral Symptoms
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Valproic Acid
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs

ClinicalTrials.gov processed this record on September 30, 2014