Creatine Monohydrate as Adjuvant Therapy for Bipolar Depression

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01655030

Enrollment

Registered

2012-08-01

Start date

2012-07-31

Completion date

2016-03-31

Last updated

2023-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar I Disorder, Current Episode Depressed

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.

Interventions

DIETARY_SUPPLEMENTcreatine monohydrate

DIETARY_SUPPLEMENTplacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

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

Design outcomes

Primary

Measure	Time frame	Description
MADRS (Montgomery-Asberg Depression Rating Scale)	6 weeks	change of score on the Montgomery-Asberg Depression Rating Scale

Secondary

Measure	Time frame	Description
HDRS-17 (Hamilton Depression Rating Scale - 17-item version)	6 weeks	change of score on the Hamilton Depression Rating Scale - 17-item version

Other

Measure	Time frame	Description
CGI (Clinical Global Impressions Scale) - Severity and Improvement	6 weeks	change of score on the Clinical Global Impressions Scale
YMRS (Young Mania Rating Scale)	6 weeks	change of score on the Young Mania Rating Scale

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026