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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
  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
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: 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:
Depression
Behavioral Symptoms

ClinicalTrials.gov processed this record on November 25, 2014