A Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Efficacy of Creatine Monohydrate as Adjunctive Therapy for Bipolar Depression
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Sao Paulo
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- MADRS (Montgomery-Asberg Depression Rating Scale)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
placebo
6g qd for 6 weeks
Intervention: placebo (Dietary Supplement)
creatine monohydrate
6g qd for 6 weeks
Intervention: creatine monohydrate (Dietary Supplement)
Outcomes
Primary Outcomes
MADRS (Montgomery-Asberg Depression Rating Scale)
Time Frame: 6 weeks
change of score on the Montgomery-Asberg Depression Rating Scale
Secondary Outcomes
- HDRS-17 (Hamilton Depression Rating Scale - 17-item version)(6 weeks)
Investigators
Ricardo Alexandre Toniolo
MD
University of Sao Paulo