Creatine Monohydrate as Adjuvant Therapy for Bipolar Depression

Study Overview
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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.

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

Conditions
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Bipolar I Disorder, Current Episode Depressed

Intervention / Treatment
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* Dietary Supplement: creatine monohydrate
* Dietary Supplement: placebo


Participation Criteria
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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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: creatine monohydrate<br>6g qd for 6 weeks | Dietary Supplement: creatine monohydrate<br> <br> |
| Placebo Comparator: placebo<br>6g qd for 6 weeks | Dietary Supplement: placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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