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Creatine Augmentation for Adolescent Females With Treatment-Resistant Major Depressive Disorder | Clinical Trials | Clareo Health

COMPLETEDPHASE4

Creatine Augmentation for Adolescent Females With Treatment-Resistant Major Depressive Disorder

Placebo-Controlled Trial of Creatine Augmentation for Adolescent Females With Treatment-Resistant Major Depressive Disorder: a Magnetic Resonance Spectroscopy Study

NCT02134808•Perry Renshaw

View on ClinicalTrials.gov

Summary

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.

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.

Eligibility

Age

12 - 21 years

Sex

FEMALE

Healthy Volunteers

Yes

Inclusion Criteria

•MAJOR DEPRESSIVE DISORDER SUBJECTS
•1. Participants must be female.
•2. Participants must be able to grant informed consent (age \>18), or parent/guardian permission plus participant assent (age \<18).
•3. Participants must meet DSM criteria for Major Depressive Disorder (MDD), with current mood state depressed for \> 2 weeks.
•4. Participants must be between the ages of 12 and 21.
•5. Current CDRS-R raw score of \> 40 or MADRS score \> 25; and CGI-S score \> 3.
•6. Participants may be enrolled in individual and/or group psychotherapy, if it has been ongoing for at least 8 weeks.
•7. 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 \[http://clinicaltrials.gov/ct2/show/NCT00018902\].
•1. Participants must be able to grant informed consent (age \> 18), or parent/guardian permission plus participant assent (age \< 18).
•2. Participants must be female.
+3 more criteria

Exclusion Criteria

•1. Unstable co-morbid medical, neurological, or psychiatric disorder.
•2. Current DSM criteria for substance abuse or dependence (excepting nicotine/cigarettes).
•3. Clinically significant suicidal or homicidal risk.
•4. Pre-existing renal disease.
•5. Proteinuria on baseline urinalysis testing.
•6. Pregnancy or breastfeeding.
•7. Sexually active and unwilling to practice contraception during the study.
•8. Contraindication to magnetic resonance imaging (e.g. ferromagnetic implant or claustrophobic anxiety).
•9. History of hypersensitivity to creatine.
•10. History of a previous failed therapeutic trial of creatine.
+21 more criteria

Locations (1)

University of Utah School of Medicine

Salt Lake City, Utah, United States

Key Dates

Start Date

November 21, 2014

Primary Completion Date

June 27, 2017

Completion Date

June 27, 2017

Last Updated

July 3, 2024

Enrollment

ACTUAL participants

Conditions

Major Depressive Disorder

Interventions

Creatine

DRUG

Placebo

DRUG

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RECRUITINGPHASE3

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 3, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Creatine Augmentation for Adolescent Females With Treatment-Resistant Major Depressive Disorder

Inclusion Criteria

Exclusion Criteria

A Phase 2 Study of Zelquistinel or Placebo for the Reduction of Symptoms of Major Depressive Disorder

A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder

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