Creatine Monohydrate as Adjuvant Therapy for Bipolar Depression
Study Details
Study Description
Brief Summary
The purpose of this study is to determine whether creatine monohydrate is effective as an adjuvant treatment for bipolar depression.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: creatine monohydrate 6g qd for 6 weeks |
Dietary Supplement: creatine monohydrate
|
| Placebo Comparator: placebo 6g qd for 6 weeks |
Dietary Supplement: placebo
|
Outcome Measures
Primary Outcome Measures
- MADRS (Montgomery-Asberg Depression Rating Scale) [6 weeks]
change of score on the Montgomery-Asberg Depression Rating Scale
Secondary Outcome Measures
- HDRS-17 (Hamilton Depression Rating Scale - 17-item version) [6 weeks]
change of score on the Hamilton Depression Rating Scale - 17-item version
Other Outcome Measures
- 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
Eligibility Criteria
Criteria
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.
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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.
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Antipsychotics, anticonvulsants, benzodiazepines, and thyroid supplementation will be allowed if the dose has remained stable over the past two weeks.
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Antidepressants will be allowed if the dosage has remained stable for 4 weeks.
Exclusion Criteria:
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Subjects with substance abuse within 2 weeks before inclusion or substance dependence up to 2 months will not be included.
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Other exclusion criteria will be:
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diagnosis of schizophrenia,
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dementia,
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delirium,
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epilepsy,
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mental retardation,
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clinically unstable medical illnesses,
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preexisting renal disease,
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history of hypersensibility to creatine.
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Not included are individuals at high risk for suicidal or homicidal behavior or self-mutilation will not be included.
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Women with gestational potential can only be included if they are using reliable contraception.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Institute of Psychiatry - HC-FMUSP | Sao Paulo | SP | Brazil | 01060-970 |
Sponsors and Collaborators
- University of Sao Paulo
Investigators
- Principal Investigator: Beny Lafer, PhD, Bipolar Disorder Research Program, Coordinator, IPq-HC-FMUSP
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CR-BD-RCT