NCT01601210

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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P50-P75 for early_phase_1 major-depressive-disorder

Timeline
Completed

Started Jun 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 17, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 17, 2012

Completed
15 days until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

October 25, 2016

Status Verified

October 1, 2016

Enrollment Period

1.9 years

First QC Date

April 17, 2012

Last Update Submit

October 24, 2016

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

  • Brain PCr concentrations

    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.

    8 weeks

Study Arms (4)

Placebo

PLACEBO COMPARATOR
Drug: Creatine monohydrate or placebo

2 grams of creatine

ACTIVE COMPARATOR
Drug: Creatine monohydrate or placebo

4 grams of creatine

ACTIVE COMPARATOR
Drug: Creatine monohydrate or placebo

10 grams of creatine

ACTIVE COMPARATOR
Drug: Creatine monohydrate or placebo

Interventions

Creatine monohydrate or placeboDRUG

Placebo, 2g, 4g, and 10g of creatine monohydrate

10 grams of creatine2 grams of creatine4 grams of creatinePlacebo

Eligibility Criteria

Age13 Years - 21 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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."

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84108, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Creatine

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

GuanidinesAmidinesOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Douglas Kondo, MD

    University of Utah

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD, MBA

Study Record Dates

First Submitted

April 17, 2012

First Posted

May 17, 2012

Study Start

June 1, 2012

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

October 25, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will share

Locations

US(1)