- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02134808
Creatine Augmentation for Adolescent Females With Treatment-Resistant Major Depressive Disorder
April 5, 2019 updated by: Perry Renshaw
Placebo-Controlled Trial of Creatine Augmentation for Adolescent Females With Treatment-Resistant Major Depressive Disorder: a Magnetic Resonance Spectroscopy Study
The primary hypothesis is that compared to placebo, 10g of daily creatine monohydrate for eight weeks will be associated with significant increases in frontal lobe phosphocreatine and beta-nucleoside triphosphate (β-NTP) concentrations.
A secondary hypothesis is that decreased depressive symptoms measured with the Children's Depression Rating Scale-Revised (CDRS-R) and Montgomery-Asberg Depression Rating Scale (MADRS) will be reciprocally correlated with increased β-NTP concentrations.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The current protocol seeks to expand upon the investigators previous work by opening recruitment on a pilot study of creatine 10g daily vs. placebo as a treatment for female adolescents with SSRI-resistant MDD.
The purpose of the pilot study is twofold: A) to evaluate several aspects of the feasibility of creatine supplementation as a treatment for this population; and B) to estimate the effect size of adjunctive creatine, to inform the design and implementation of a potential future efficacy trial.
Study Type
Interventional
Enrollment (Actual)
71
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Utah
-
Salt Lake City, Utah, United States, 84108
- University of Utah School of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 21 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
MAJOR DEPRESSIVE DISORDER SUBJECTS
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 criteria for Major Depressive Disorder (MDD), with current mood state depressed for > 2 weeks.
- Participants must be between the ages of 12 and 21.
- Current CDRS-R raw score of > 40 or MADRS score > 25; and CGI-S score > 3.
- 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 > 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. (This definition of "Adolescent SSRI Resistant Depression" is modified from the NIH-sponsored, $17 million TORDIA Randomized Controlled Trial [http://clinicaltrials.gov/ct2/show/NCT00018902].
Exclusion Criteria:
- Unstable co-morbid medical, neurological, or psychiatric disorder.
- Current DSM criteria for substance abuse or dependence (excepting nicotine/cigarettes).
- Clinically significant suicidal or homicidal risk.
- Pre-existing renal disease.
- Proteinuria on baseline urinalysis testing.
- Pregnancy or breastfeeding.
- Sexually active and unwilling to practice contraception during the study.
- Contraindication to magnetic resonance imaging (e.g. ferromagnetic implant or claustrophobic anxiety).
- 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."
Study Withdrawal Criteria:
- Withdrawal of parental permission, participant informed consent or participant assent.
- Onset of a psychotic disorder or bipolar disorder.
- Intolerable, or clinically-significant side effects to creatine.
- Worsening depression, as demonstrated by an increase in CDRS-R or MADRS score > 25% from baseline.
- Positive pregnancy test.
- A significant change to the participant's medication or psychotherapy treatment from the regimen reported at their baseline/screening visit (e.g. if the SSRI is discontinued).
- Incarceration, as the study is not approved to conduct "Research Involving Prisoners."
- If a clinically-significant intracranial lesion is found by the Radiologist on a participant's baseline brain scan, they will be withdrawn from the study and referred for appropriate medical care.
- The principal investigator retains the right to withdraw participants from the study without their permission, in the event they are unwilling or unable to maintain adherence with the research protocol.
HEALTHY COMPARISON SUBJECTS
Inclusion Criteria:
- Participants must be able to grant informed consent (age > 18), or parent/guardian permission plus participant assent (age < 18).
- Participants must be female.
- Participants must be between the ages of 12 and 21 years.
- Participants must not meet DSM criteria for a current psychiatric illness or substance use disorder.
- Participants must have a CDRS-R score < 30.
Exclusion Criteria:
- Unstable medical or neurological illness.
- Clinically-significant psychiatric or substance use disorder.
- Pregnant subjects, due to the unknown effects of MRI/MRS scans on a fetus. In addition, women of childbearing potential who are unable or unwilling to practice contraception during the study will be excluded. Female participants who are of childbearing potential must have a negative urine pregnancy test before the MRI/MRS scan.
- Participants with a contraindication to MRI/MRS scanning, such as a metallic implant.
Study Withdrawal Criteria:
- Withdrawal of parental permission or participant assent.
- Onset of a psychotic disorder or depression.
- Positive pregnancy test.
- A significant change to the participant's medication or psychotherapy treatment from the regimen reported at their baseline/screening visit, unless directed by the principal investigator.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Creatine
Subjects randomized to this study arm will receive 10 grams of creatine daily for 8 weeks.
|
Creatine is a nutritional supplement.
Other Names:
|
Placebo Comparator: Placebo
Subjects randomized to this study arm will receive 10 grams of placebo daily for 8 weeks.
|
The placebo is an inactive ingredient similar in appearance, weight and density to the active treatment.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Brain phosphocreatine (PCr) concentrations
Time Frame: 8 weeks
|
PCr will be measured through phosphorus magnetic resonance spectroscopy (31P-MRS).
This will be performed in a 3 Tesla magnetic resonance imaging (MRI) scanner.
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Children's Depression Rating Scale-Revised (CDRS-R); Montgomery-Asberg Depression Rating Scale (MADRS)
Time Frame: 8 weeks
|
The CDRS-R and MADRS will be administered to understand the severity of depressive symptoms, and how these symptoms change throughout the course of the study.
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Douglas Kondo, MD, University of Utah
- Principal Investigator: Perry F Renshaw, MD, PhD, MBA, University of Utah
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 21, 2014
Primary Completion (Actual)
June 27, 2017
Study Completion (Actual)
June 27, 2017
Study Registration Dates
First Submitted
May 6, 2014
First Submitted That Met QC Criteria
May 7, 2014
First Posted (Estimate)
May 9, 2014
Study Record Updates
Last Update Posted (Actual)
April 9, 2019
Last Update Submitted That Met QC Criteria
April 5, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 00073442
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Major Depressive Disorder
-
Shalvata Mental Health CenterUnknownMAjor Depressive DisorderIsrael
-
York UniversityCentre for Addiction and Mental HealthSuspendedDisorder, Major DepressiveCanada
-
Seasons Biotechnology (Taizhou) Co., Ltd.CompletedMajor Depressive Disorder (MDDIndia
-
Gangnam Severance HospitalCompletedMajor Depressive Disorder(MDD)Korea, Republic of
-
University College, LondonCompletedUnipolar Major Depressive DisorderUnited Kingdom
-
Fundació Institut de Recerca de l'Hospital de la...Fondo de Investigacion SanitariaUnknown
-
Seasons Biotechnology (Taizhou) Co., Ltd.CompletedMajor Depressive Disorder (MDD)India
-
Repurposed Therapeutics, Inc.Unknown
-
GlaxoSmithKlineCompletedMajor Depressive Disorder (MDD)United States
-
AccexibleRecruitingMajor Depressive Disorder (MDD)Spain
Clinical Trials on Creatine
-
Texas A&M UniversityNutraboltCompletedDietary Modification
-
University of Novi Sad, Faculty of Sport and Physical...Completed
-
GlaxoSmithKlineCompletedSports Nutritional SciencesUnited Kingdom
-
Massachusetts General HospitalCompletedHuntington's Disease (HD)United States
-
Texas A&M UniversityNutraboltCompletedDietary Supplementation
-
Dynamical Business and Science Society - DBSS International...CES University; INDEPORTES AntioquiaCompleted
-
The Cleveland ClinicCompletedHypercholesterolemia | Weakness | Cramps | AchesUnited States
-
Silesian Centre for Heart DiseasesRecruiting
-
University of UtahNational Cancer Institute (NCI)RecruitingFatigue | Sedentary Lifestyle | Metastatic Prostate Carcinoma | Stage IV Prostate Cancer AJCC (American Joint Committee on Cancer) v8 | Stage IVA Prostate Cancer AJCC (American Joint Committee on Cancer) v8 | Stage IVB Prostate Cancer AJCC (American Joint Committee on Cancer) v8United States
-
Beth Israel Medical CenterCompleted