Creatine Monohydrate as Adjuvant Therapy for Bipolar Depression

This study is not yet open for participant recruitment.
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
  Purpose

The purpose of this study is to determine whether creatine monohydrate is effective as an adjuvant treatment for bipolar depression.


Condition Intervention Phase
Bipolar I Disorder
Current Episode Depressed
Dietary Supplement: creatine monohydrate
Dietary Supplement: placebo
Phase 4

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, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Efficacy of Creatine Monohydrate as Adjunctive Therapy for Bipolar Depression

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • MADRS (Montgomery-Asberg depression Rating Scale) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • HDRS-17 (Hamilton Depression Rating Scale - 17-item version) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • 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 ]

Estimated Enrollment: 44
Study Start Date: July 2012
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: creatine monohydrate
6g qd for 6 weeks
Dietary Supplement: creatine monohydrate
Placebo Comparator: placebo
6g qd for 6 weeks
Dietary Supplement: placebo

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01655030

Contacts
Contact: Ricardo Toniolo, MD 55 11 26617928 ricardo.toniolo@uol.com.br

Locations
Brazil
Institute of Psychiatry - HC-FMUSP
Sao Paulo, SP, Brazil, 01060-970
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Beny Lafer, PhD Bipolar Disorder Research Program, Coordinator, IPq-HC-FMUSP
  More Information

No publications provided

Responsible Party: Ricardo Alexandre Toniolo, MD, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01655030     History of Changes
Other Study ID Numbers: CR-BD-RCT
Study First Received: July 29, 2012
Last Updated: September 7, 2013
Health Authority: Brazil: National Committee of Ethics in Research

Additional relevant MeSH terms:
Bipolar Disorder
Depression
Depressive Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on April 17, 2014