Creatine Monohydrate as Adjuvant Therapy for Bipolar Depression

University of Sao Paulo

Status: Completed

Conditions: Current Episode Depressed; Bipolar I Disorder

Treatments: Dietary Supplement: creatine monohydrate; Dietary Supplement: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01655030

CR-BD-RCT

Details and patient eligibility

About

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

Full 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.

Enrollment: 44 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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44 participants in 2 patient groups, including a placebo group

creatine monohydrate

Experimental group

Description:

6g qd for 6 weeks

Treatment:

Dietary Supplement: creatine monohydrate

placebo

Placebo Comparator group

Description:

6g qd for 6 weeks

Treatment:

Dietary Supplement: placebo