Clinical trial NCT01655030: Creatine Monohydrate as Adjuvant Therapy for Bipolar Depression
Official title: A Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Efficacy of Creatine Monohydrate as Adjunctive Therapy for Bipolar Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bipolar I Disorder
Current Episode Depressed
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2012-08-01
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.
* 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.

Primary outcomes:
measure: MADRS (Montgomery-Asberg Depression Rating Scale)
timeFrame: 6 weeks
Secondary outcomes:
measure: HDRS-17 (Hamilton Depression Rating Scale - 17-item version)
timeFrame: 6 weeks
Other outcomes:
measure: CGI (Clinical Global Impressions Scale) - Severity and Improvement
timeFrame: 6 weeks
measure: YMRS (Young Mania Rating Scale)
timeFrame: 6 weeks
Locations:
city: Sao Paulo
country: Brazil
facility: Institute of Psychiatry - HC-FMUSP
state: SP
Study officials:
affiliation: Bipolar Disorder Research Program, Coordinator, IPq-HC-FMUSP
name: Beny Lafer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Toniolo RA, Silva M, Fernandes FBF, Amaral JAMS, Dias RDS, Lafer B. A randomized, double-blind, placebo-controlled, proof-of-concept trial of creatine monohydrate as adjunctive treatment for bipolar depression. J Neural Transm (Vienna). 2018 Feb;125(2):247-257. doi: 10.1007/s00702-017-1817-5. Epub 2017 Nov 24.