Creatine Monohydrate as Adjuvant Therapy for Bipolar Depression

NCT01655030 | Completed

• 1 other identifier: CR-BD-RCT
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Bipolar I Disorder; Current Episode Depressed

Outcome Measures

Primary Outcomes (1)

• MADRS (Montgomery-Asberg Depression Rating Scale)

  change of score on the Montgomery-Asberg Depression Rating Scale

  6 weeks

Secondary Outcomes (1)

• HDRS-17 (Hamilton Depression Rating Scale - 17-item version)

  6 weeks

Other Outcomes (2)

• CGI (Clinical Global Impressions Scale) - Severity and Improvement

  6 weeks

• YMRS (Young Mania Rating Scale)

  6 weeks

Study Arms (2)

creatine monohydrate

EXPERIMENTAL

6g qd for 6 weeks

Dietary Supplement: creatine monohydrate

placebo

PLACEBO COMPARATOR

6g qd for 6 weeks

Dietary Supplement: placebo

Interventions

creatine monohydrate DIETARY_SUPPLEMENT

creatine monohydrate

placebo DIETARY_SUPPLEMENT

placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Institute of Psychiatry - HC-FMUSP

São Paulo, São Paulo, 01060-970, Brazil

Location

Related Publications (1)

• 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.

  PMID: 29177955 DERIVED

MeSH Terms

Interventions

Creatine

Intervention Hierarchy (Ancestors)

Guanidines; Amidines; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Beny Lafer, PhD

  Bipolar Disorder Research Program, Coordinator, IPq-HC-FMUSP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 29, 2012
• First Posted: August 1, 2012
• Study Start: July 1, 2012
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: December 5, 2023

Record last verified: 2023-12

Locations

BR (1)