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

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 Ricardo Alexandre Toniolo, University of Sao Paulo:

Primary Outcome Measures:
  • MADRS (Montgomery-Asberg Depression Rating Scale) [ Time Frame: 6 weeks ]
    change of score on the Montgomery-Asberg Depression Rating Scale


Secondary Outcome Measures:
  • 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


Other Outcome Measures:
  • 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


Estimated Enrollment: 44
Study Start Date: July 2012
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: May 2018 (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

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01655030


Contacts
Contact: Ricardo Toniolo, MD 55 11 26617928 ricardotoniolo.md@gmail.com

Locations
Brazil
Institute of Psychiatry - HC-FMUSP Recruiting
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

Responsible Party: Ricardo Alexandre Toniolo, MD, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01655030     History of Changes
Other Study ID Numbers: CR-BD-RCT
First Submitted: July 29, 2012
First Posted: August 1, 2012
Last Update Posted: October 26, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Depression
Bipolar Disorder
Behavioral Symptoms
Bipolar and Related Disorders
Mental Disorders