Creatine Monohydrate as Adjuvant Therapy for Bipolar Depression

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2013 by University of Sao Paulo
Sponsor:
Information provided by (Responsible Party):
Ricardo Alexandre Toniolo, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01655030
First received: July 29, 2012
Last updated: September 7, 2013
Last verified: September 2013

July 29, 2012
September 7, 2013
July 2012
November 2015   (final data collection date for primary outcome measure)
MADRS (Montgomery-Asberg depression Rating Scale) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Same as current
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 ] [ Designated as safety issue: No ]
Same as current
  • CGI (Clinical Global Impressions Scale) - Severity and Improvement [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • YMRS (Young Mania Rating Scale) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Same as current
 
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.
 
Not yet recruiting
44
November 2015
November 2015   (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.
Both
18 Years to 60 Years
No
Contact: Ricardo Toniolo, MD 55 11 26617928 ricardo.toniolo@uol.com.br
Brazil
 
NCT01655030
CR-BD-RCT
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
September 2013

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