Creatine Monohydrate as Adjuvant Therapy for Bipolar Depression

Not Applicable

Completed

• Conditions: Bipolar I Disorder; Current Episode Depressed
• Interventions: Dietary Supplement: creatine monohydrate; Dietary Supplement: placebo

• Registration Number: NCT01655030
• Lead Sponsor: University of Sao Paulo

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-07-29
• Study First Submitted QC: 2012-07-31
• Study First Posted: 2012-08-01
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-01
• Last Update Posted: 2023-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
creatine monohydrate	creatine monohydrate	6g qd for 6 weeks
placebo	placebo	6g qd for 6 weeks

Primary Outcome Measures

Name	Time	Method
MADRS (Montgomery-Asberg Depression Rating Scale)	6 weeks	change of score on the Montgomery-Asberg Depression Rating Scale

Secondary Outcome Measures

Name	Time	Method
HDRS-17 (Hamilton Depression Rating Scale - 17-item version)	6 weeks	change of score on the Hamilton Depression Rating Scale - 17-item version

Trial Locations

Locations (1)

Institute of Psychiatry - HC-FMUSP; 🇧🇷 Sao Paulo, SP, Brazil