Creatine Treatment for Female Adolescents With Depression Who Are Non-Responders to Fluoxetine or Escitalopram

NCT00851006 | Completed Phase 2 Results DMC

• 1 other identifier: 33465
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to see if creatine, which is a naturally occurring chemical in the body, is effective for treating Major Depressive Disorder (MDD) in female teenagers. Creatine may have effects of interest in the brain. The reason for the MRI component of this study is to learn about new ways to see inside the brain. The investigators will use magnetic fields and radio waves to look at the brain and chemicals in the brain. The investigators hope that this technique will have medial use in the future. The primary hypothesis of the study is that oral creatine supplementation will have a beneficial effect as adjunctive therapy in female adolescents with MDD who are non-responders to an adequate trial of the SSRIs Fluoxetine or Escitalopram.

Conditions

Major Depressive Disorder

Keywords

Depression; Females; Adolescents

Outcome Measures

Primary Outcomes (1)

• Mean Children's Depression Rating Scale (CDRS-R) [Reference: Poznanski EO et al. Preliminary Studies of the Reliability and Validity of the Children's Depression Rating Scale. J Am Acad Child Psychiatry. 1984 Mar;23(2):191-7.]

  The CDRS-R is a 17-item scale, with items ranging from 1 to 5 or 1 to 7 (possible total score from 17 to 113), rated by a clinician via interviews with the child or parent. Scores ≥40 are indicative of depression, whereas scores ≤28 is often used to define remission

  8 weeks

Secondary Outcomes (1)

• 31-phosphorus Magnetic Resonance Spectroscopy Phosphocreatine Metabolite

  8 weeks

Study Arms (1)

Open-Label Creatine

EXPERIMENTAL

Creatine Monohydrate 4 grams daily by mouth

Drug: Creatine Monohydrate

Interventions

Creatine Monohydrate DRUG

Creapure brand of creatine monohydrate

Also known as: Creapure

Open-Label Creatine

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Participants must meet DSM-IV-TR criteria for Major Depressive Disorder, with current mood state depressed for ≥ 2 weeks.
• Participants must be females
• Participants must be between the age of 13 and 18 years.
• Participants must have had an adequate trial of fluoxetine, defined as a trial of ≥ 8 weeks of treatment, with a dose of ≥ 40mg daily for ≥ 4 weeks. If the participant had a trial of 40mg daily and was unable to tolerate it, a dose of 20mg for ≥ 8 weeks is acceptable; OR
• Participants must have had an adequate trial of escitalopram, defined as a trial of ≥ 8 weeks of treatment, with a dose of ≥ 20 mg daily for ≥ 4 weeks. If the participant had a trial of 20 mg daily and was unable to tolerate it, a dose of 10 mg for ≥ 8 weeks is acceptable.
• Participants must have a CDRS-R score of ≥ 40 and a CGI-S score of ≥ 4.
• Participants must be able to give informed consent or assent, and where applicable, parent(s)/guardian(s) must be able to give informed permission for study participation.
• Participants must be females
• Participants must be between the age of 13 and 18 years.
• Participants must not meet DSM-IV-TR diagnostic criteria for a psychiatric or substance abuse disorder.
• Participants must be able to give informed consent or assent and, where applicable, parent(s)/guardian(s) must be able to give informed permission for study participation.

You may not qualify if:

• Unstable co-morbid medical, neurological or psychiatric disorder.
• Pre-existing renal disease.
• Proteinuria or microalbuminuria.
• Pregnant females, nursing mothers, or females of childbearing potential who are unable or unwilling to practice birth control during the study. Participants who are of child-bearing potential must have a negative urine pregnancy test before each MRI/MRS brain scan.
• High risk for suicidal behavior, homicidal behavior or self-harm.
• Adolescents who are unlikely to be able to comply with the study protocol.
• DSM-IV-TR criteria for current substance abuse or substance dependence, with the exception of nicotine abuse or dependence.
• Contraindication to MRI/MRS brain scans, such as ferromagnetic implants or claustrophobic anxiety.
• Documented or suspected history of intellectual disability (Full-Scale I.Q. \< 70).
• History of hypersensitivity to creatine monohydrate.
• Clinically significant psychiatric or substance abuse disorder.
• Unstable medical or neurological illness.
• Pregnancy, due to the unknown effects of MRI/MRS scanning on a developing fetus.
• Females of childbearing potential who are unable or unwilling to practice contraception during the study.
• Positive urine pregnancy test.

Sponsors & Collaborators

• University of Utah: lead
• AlzChem, LLC: collaborator

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84108, United States

Location

Related Publications (2)

• Kondo DG, Hellem TL, Sung YH, Kim N, Jeong EK, Delmastro KK, Shi X, Renshaw PF. Review: magnetic resonance spectroscopy studies of pediatric major depressive disorder. Depress Res Treat. 2011;2011:650450. doi: 10.1155/2011/650450. Epub 2010 Oct 4.

  PMID: 21197097 BACKGROUND

• Kondo DG, Sung YH, Hellem TL, Fiedler KK, Shi X, Jeong EK, Renshaw PF. Open-label adjunctive creatine for female adolescents with SSRI-resistant major depressive disorder: a 31-phosphorus magnetic resonance spectroscopy study. J Affect Disord. 2011 Dec;135(1-3):354-61. doi: 10.1016/j.jad.2011.07.010. Epub 2011 Aug 9.

  PMID: 21831448 RESULT

Related Links

• University of Utah Brain Institute Website

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

Creatine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Douglas Kondo, M.D.
• Organization: University of Utah

doug.kondo@hsc.utah.edu

801-587-1549

Study Officials

• Douglas G Kondo, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 23, 2009
• First Posted: February 25, 2009
• Study Start: April 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: May 12, 2017
• Results First Posted: January 13, 2015

Record last verified: 2017-04

Locations

US (1)