We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Creatine Monohydrate as Adjuvant Therapy for Bipolar Depression

This study is currently recruiting participants.
Verified October 2017 by Ricardo Alexandre Toniolo, University of Sao Paulo
Sponsor:
ClinicalTrials.gov Identifier:
NCT01655030
First Posted: August 1, 2012
Last Update Posted: October 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Ricardo Alexandre Toniolo, University of Sao Paulo
July 29, 2012
August 1, 2012
October 26, 2017
July 2012
May 2018   (Final data collection date for primary outcome measure)
MADRS (Montgomery-Asberg Depression Rating Scale) [ Time Frame: 6 weeks ]
change of score on the Montgomery-Asberg Depression Rating Scale
MADRS (Montgomery-Asberg Depression Rating Scale) [ Time Frame: 6 weeks ]
Complete list of historical versions of study NCT01655030 on ClinicalTrials.gov Archive Site
HDRS-17 (Hamilton Depression Rating Scale - 17-item version) [ Time Frame: 6 weeks ]
change of score on the Hamilton Depression Rating Scale - 17-item version
HDRS-17 (Hamilton Depression Rating Scale - 17-item version) [ Time Frame: 6 weeks ]
  • CGI (Clinical Global Impressions Scale) - Severity and Improvement [ Time Frame: 6 weeks ]
    change of score on the Clinical Global Impressions Scale
  • YMRS (Young Mania Rating Scale) [ Time Frame: 6 weeks ]
    change of score on the Young Mania Rating Scale
  • CGI (Clinical Global Impressions Scale) - Severity and Improvement [ Time Frame: 6 weeks ]
  • YMRS (Young Mania Rating Scale) [ Time Frame: 6 weeks ]
 
Creatine Monohydrate as Adjuvant Therapy for Bipolar Depression
A Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Efficacy of Creatine Monohydrate as Adjunctive Therapy for Bipolar Depression
The purpose of this study is to determine whether creatine monohydrate is effective as an adjuvant treatment for bipolar depression.
Bipolar Depression is associated with high rates of disability and increased mortality. Despite its major negative impact, treatment of Bipolar Depression is still controversial and only partially efficacious, with over half of patients not responding adequately to available treatment. In this context, the use of drugs that modulate energy metabolism has been proposed as promising new option as treatment strategies for bipolar depression. The aim of our proposed study is to perform a 6-week randomized, double-blind, placebo-controlled clinical trial of creatine monohydrate as an adjuvant treatment for bipolar depression.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Bipolar I Disorder
  • Current Episode Depressed
  • Dietary Supplement: creatine monohydrate
  • Dietary Supplement: placebo
  • Experimental: creatine monohydrate
    6g qd for 6 weeks
    Intervention: Dietary Supplement: creatine monohydrate
  • Placebo Comparator: placebo
    6g qd for 6 weeks
    Intervention: Dietary Supplement: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
44
July 2018
May 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Individuals eligible for the study will be adults aged 18 to 60 years of age who met DSM-IV criteria assessed by the SCID (Structural Clinical Interview for DSM-IV) for type I bipolar disorder, current episode depressed.
  • Patients who have scored > 19 on the Montgomery-Asberg Depression Rating Scale (MADRS) will be included, although more than two weeks of treatment with lithium (serum level> 0.8 mEq / L), valproate (serum levels> 50 mg / L) or quetiapine (300-600mg/dia dose) or drug combination.
  • Antipsychotics, anticonvulsants, benzodiazepines, and thyroid supplementation will be allowed if the dose has remained stable over the past two weeks.
  • Antidepressants will be allowed if the dosage has remained stable for 4 weeks.

Exclusion Criteria:

  • Subjects with substance abuse within 2 weeks before inclusion or substance dependence up to 2 months will not be included.
  • Other exclusion criteria will be:

    • diagnosis of schizophrenia,
    • dementia,
    • delirium,
    • epilepsy,
    • mental retardation,
    • clinically unstable medical illnesses,
    • preexisting renal disease,
    • history of hypersensibility to creatine.
  • Not included are individuals at high risk for suicidal or homicidal behavior or self-mutilation will not be included.
  • Women with gestational potential can only be included if they are using reliable contraception.
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
No
Contact: Ricardo Toniolo, MD 55 11 26617928 ricardotoniolo.md@gmail.com
Brazil
 
 
NCT01655030
CR-BD-RCT
No
Not Provided
Not Provided
Ricardo Alexandre Toniolo, University of Sao Paulo
University of Sao Paulo
Not Provided
Principal Investigator: Beny Lafer, PhD Bipolar Disorder Research Program, Coordinator, IPq-HC-FMUSP
University of Sao Paulo
October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP