Back to results

Creatine Monohydrate as Adjuvant Therapy for Bipolar Depression

Primary Purpose

Bipolar I Disorder, Current Episode Depressed

Status

Unknown status

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

creatine monohydrate

placebo

About this trial

This is an interventional treatment trial for Bipolar I Disorder

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Institute of Psychiatry - HC-FMUSPRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

creatine monohydrate

placebo

Arm Description

6g qd for 6 weeks

Outcomes

Primary Outcome Measures

MADRS (Montgomery-Asberg Depression Rating Scale)

change of score on the Montgomery-Asberg Depression Rating Scale

Secondary Outcome Measures

HDRS-17 (Hamilton Depression Rating Scale - 17-item version)

change of score on the Hamilton Depression Rating Scale - 17-item version

Full Information

NCT ID

NCT01655030

First Posted

July 29, 2012

Last Updated

September 30, 2021

Sponsor

University of Sao Paulo

1. Study Identification

Unique Protocol Identification Number

NCT01655030

Brief Title

Creatine Monohydrate as Adjuvant Therapy for Bipolar Depression

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Unknown status

Study Start Date

July 2012 (undefined)

Primary Completion Date

November 2021 (Anticipated)

Study Completion Date

January 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Sao Paulo

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bipolar I Disorder, Current Episode Depressed

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

creatine monohydrate

Arm Type

Experimental

Arm Description

6g qd for 6 weeks

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

6g qd for 6 weeks

Intervention Type

Dietary Supplement

Intervention Name(s)

creatine monohydrate

Intervention Type

Dietary Supplement

Intervention Name(s)

placebo

Primary Outcome Measure Information:

Title

MADRS (Montgomery-Asberg Depression Rating Scale)

Description

change of score on the Montgomery-Asberg Depression Rating Scale

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

HDRS-17 (Hamilton Depression Rating Scale - 17-item version)

Description

change of score on the Hamilton Depression Rating Scale - 17-item version

Time Frame

6 weeks

Other Pre-specified Outcome Measures:

Title

CGI (Clinical Global Impressions Scale) - Severity and Improvement

Description

change of score on the Clinical Global Impressions Scale

Time Frame

6 weeks

Title

YMRS (Young Mania Rating Scale)

Description

change of score on the Young Mania Rating Scale

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ricardo Toniolo, MD

Phone

55 11 26617928

ricardotoniolo.md@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Beny Lafer, PhD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

Institute of Psychiatry - HC-FMUSP

City

Sao Paulo

State/Province

ZIP/Postal Code

01060-970

Country

Brazil

Individual Site Status

Recruiting

12. IPD Sharing Statement

Citations:

PubMed Identifier

29177955

Citation

Toniolo RA, Silva M, Fernandes FBF, Amaral JAMS, Dias RDS, Lafer B. A randomized, double-blind, placebo-controlled, proof-of-concept trial of creatine monohydrate as adjunctive treatment for bipolar depression. J Neural Transm (Vienna). 2018 Feb;125(2):247-257. doi: 10.1007/s00702-017-1817-5. Epub 2017 Nov 24.

Results Reference

derived

Learn more about this trial

Creatine Monohydrate as Adjuvant Therapy for Bipolar Depression

We'll reach out to this number within 24 hrs