Back to resultsDose-Ranging Trial of Creatine Augmentation for Adolescent Females With Treatment-Resistant Major Depressive Disorder
Primary Purpose
Major Depressive Disorder
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Creatine monohydrate or placebo
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder
Eligibility 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."
Sites / Locations
- University of Utah
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Placebo
2 grams of creatine
4 grams of creatine
10 grams of creatine
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01601210
Brief Title
Dose-Ranging Trial of Creatine Augmentation for Adolescent Females With Treatment-Resistant Major Depressive Disorder
Official Title
Placebo-Controlled Dose-Ranging Trial of Creatine Augmentation for Adolescent Females With Treatment-Resistant Major Depressive Disorder: a Magnetic Resonance Spectroscopy Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Perry Renshaw
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
2 grams of creatine
Arm Type
Active Comparator
Arm Title
4 grams of creatine
Arm Type
Active Comparator
Arm Title
10 grams of creatine
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Creatine monohydrate or placebo
Intervention Description
Placebo, 2g, 4g, and 10g of creatine monohydrate
Primary Outcome Measure Information:
Title
Brain PCr concentrations
Description
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.
Time Frame
8 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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."
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Douglas Kondo, MD
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Dose-Ranging Trial of Creatine Augmentation for Adolescent Females With Treatment-Resistant Major Depressive Disorder
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