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

NCT02134808 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2024-07-03

Study results available
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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.

Conditions

Interventions

DRUG

Creatine

Creatine is a nutritional supplement.

DRUG

Placebo

The placebo is an inactive ingredient similar in appearance, weight and density to the active treatment.

Sponsors & Collaborators

  • Perry Renshaw

    lead OTHER

Principal Investigators

  • Douglas Kondo, MD · University of Utah

  • Perry F Renshaw, MD, PhD, MBA · University of Utah

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
21 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-11-21
Primary Completion
2017-06-27
Completion
2017-06-27
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02134808 on ClinicalTrials.gov