Dose-Ranging Trial of Creatine Augmentation for Adolescent Females With Treatment-Resistant Major Depressive Disorder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Utah
ClinicalTrials.gov Identifier:
NCT01601210
First received: April 17, 2012
Last updated: May 12, 2014
Last verified: May 2014
  Purpose

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 is that compared to placebo, 2g, 4g, and 10g of creatine monohydrate for eight weeks will be associated with a significant increase in brain phosphocreatine (PCr) concentrations. A secondary hypothesis is that decreased depressive symptoms measured with the Children Depression Rating Scale-Revised (CDRS-R) and Montgomery Asberg Depression Rating Scale (MADRS) will be reciprocally correlated with increased β-NTP concentrations.


Condition Intervention Phase
Major Depressive Disorder
Drug: Creatine monohydrate or placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Placebo-Controlled Dose-Ranging Trial of Creatine Augmentation for Adolescent Females With Treatment-Resistant Major Depressive Disorder: a Magnetic Resonance Spectroscopy Study

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • Brain PCr concentrations [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    The primary hypothesis is that compared to placebo, 2g, 4g, and 10g of creatine monohydrate for eight weeks will be associated with a significant increase in brain phosphocreatine (PCr) concentrations.


Enrollment: 32
Study Start Date: June 2012
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Creatine monohydrate or placebo
Placebo, 2g, 4g, and 10g of creatine monohydrate
Active Comparator: 2 grams of creatine Drug: Creatine monohydrate or placebo
Placebo, 2g, 4g, and 10g of creatine monohydrate
Active Comparator: 4 grams of creatine Drug: Creatine monohydrate or placebo
Placebo, 2g, 4g, and 10g of creatine monohydrate
Active Comparator: 10 grams of creatine Drug: Creatine monohydrate or placebo
Placebo, 2g, 4g, and 10g of creatine monohydrate

  Eligibility

Ages Eligible for Study:   13 Years to 21 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Participants must be female.
  • Participants must be able to grant informed consent (age > 18), or parent/guardian permission plus participant assent (age < 18).
  • Participants must meet DSM-IV criteria for MDD, with current mood state depressed for > 2 weeks.
  • Participants must be between the ages of 13 and 21.
  • Current CDRS-R raw score of > 40 or MADRS score > 25; and CGI-S score > 4.
  • Participants may be enrolled in individual and/or group psychotherapy, if it has been ongoing for at least 8 weeks.
  • Participants must have been in treatment with an SSRI for at least 8 weeks, the last 4 of which were at a dosage of > or equal to 20 mg per day of fluoxetine or its equivalent, e.g. 20 mg per day of paroxetine, 20 mg citalopram, 10 mg escitalopram, or 100 mg sertraline. If the participant attempted, but could not tolerate, a dose comparable to 20 mg fluoxetine, they will be considered eligible.

Exclusion criteria:

  • Unstable co-morbid medical, neurological, or psychiatric disorder.
  • Current DSM-IV criteria for substance abuse or dependence (excepting nicotine/cigarettes).
  • Clinically significant suicidal or homicidal risk.
  • Pre-existing renal disease.
  • Proteinuria on baseline urinalysis testing.
  • Treatment with antiepileptic drugs, antipsychotic drugs, or lithium.
  • Pregnancy or breastfeeding.
  • Sexually active and unwilling to practice contraception during the study.
  • Contraindication to magnetic resonance imaging (e.g. ferromagnetic implant or claustrophobia)
  • History of hypersensitivity to creatine.
  • History of a previous failed therapeutic trial of creatine.
  • Participants may be outpatients or inpatients, but incarcerated persons will be excluded because this study is not approved for "Research Involving Prisoners."
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01601210

Locations
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84108
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Douglas Kondo, MD University of Utah
  More Information

No publications provided

Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT01601210     History of Changes
Other Study ID Numbers: 00055231
Study First Received: April 17, 2012
Last Updated: May 12, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on September 18, 2014