Creatine Monohydrate as Adjuvant Therapy for Bipolar Depression

Bipolar I Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01655030
• Other study ID #: CR-BD-RCT
• Status: Completed
• Phase: N/A
• Start date: July 2012
• Est. completion date: March 2016

Study information

• Verified date: December 2023
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bipolar Disorder
• Bipolar I Disorder
• Current Episode Depressed

Intervention

Dietary Supplement:
• creatine monohydrate

• placebo

Locations

Country	Name	City	State
Brazil	Institute of Psychiatry - HC-FMUSP	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	CGI (Clinical Global Impressions Scale) - Severity and Improvement	change of score on the Clinical Global Impressions Scale	6 weeks
Other	YMRS (Young Mania Rating Scale)	change of score on the Young Mania Rating Scale	6 weeks
Primary	MADRS (Montgomery-Asberg Depression Rating Scale)	change of score on the Montgomery-Asberg Depression Rating Scale	6 weeks
Secondary	HDRS-17 (Hamilton Depression Rating Scale - 17-item version)	change of score on the Hamilton Depression Rating Scale - 17-item version	6 weeks