Creatine Monohydrate as Adjuvant Therapy for Bipolar Depression

This study is not yet open for participant recruitment.

Verified July 2012 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: July 31, 2012

Last verified: July 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

July 29, 2012

Last Updated Date

July 31, 2012

Start Date ^ICMJE

July 2012

Estimated Primary Completion Date

November 2015 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01655030 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

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 ]

Original Other Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Creatine Monohydrate as Adjuvant Therapy for Bipolar Depression

Official Title ^ICMJE

A Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Efficacy of Creatine Monohydrate as Adjunctive Therapy in the Treatment of Bipolar Depression

Brief Summary

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

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Bipolar I Disorder
Current Episode Depressed

Intervention ^ICMJE

Dietary Supplement: creatine monohydrate
Dietary Supplement: placebo

Study Arm (s)

Experimental: creatine monohydrate
1,5g 2 caps bid

Intervention: Dietary Supplement: creatine monohydrate
Placebo Comparator: placebo
1,5g 2 caps bid

Intervention: Dietary Supplement: placebo

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

November 2015

Estimated Primary Completion Date

November 2015 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Ricardo Toniolo, MD

55 11 26617928

ricardo.toniolo@uol.com.br

Location Countries ^ICMJE

Brazil

Administrative Information

NCT Number ^ICMJE

NCT01655030

Other Study ID Numbers ^ICMJE

CR-BD-RCT

Has Data Monitoring Committee

Responsible Party

Ricardo Alexandre Toniolo, University of Sao Paulo

Study Sponsor ^ICMJE

University of Sao Paulo

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Beny Lafer, PhD

Bipolar Disorder Research Program, Coordinator, IPq-HC-FMUSP

Information Provided By

University of Sao Paulo

Verification Date

July 2012

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

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