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Creatine Monohydrate as Adjuvant Therapy for Bipolar Depression

NCT ID: NCT01655030

Last Updated: 2023-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2016-03-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Bipolar I Disorder Current Episode Depressed

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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creatine monohydrate

6g qd for 6 weeks

Group Type EXPERIMENTAL

creatine monohydrate

Intervention Type DIETARY_SUPPLEMENT

placebo

6g qd for 6 weeks

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DIETARY_SUPPLEMENT

Interventions

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creatine monohydrate

Intervention Type DIETARY_SUPPLEMENT

placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Ricardo Alexandre Toniolo

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Beny Lafer, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Institute of Psychiatry - HC-FMUSP

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type DERIVED
PMID: 29177955 (View on PubMed)

Other Identifiers

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CR-BD-RCT

Identifier Type: -

Identifier Source: org_study_id