Dose-Ranging Trial of Creatine Augmentation for Adolescent Females With Treatment-Resistant Major Depressive Disorder

NCT ID: NCT01601210

Last Updated: 2016-10-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2014-05-31

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.

Conditions

Major Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Group Type: PLACEBO_COMPARATOR

Creatine monohydrate or placebo

Intervention Type: DRUG

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

2 grams of creatine

Group Type: ACTIVE_COMPARATOR

Creatine monohydrate or placebo

Intervention Type: DRUG

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

4 grams of creatine

Group Type: ACTIVE_COMPARATOR

Creatine monohydrate or placebo

Intervention Type: DRUG

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

10 grams of creatine

Group Type: ACTIVE_COMPARATOR

Creatine monohydrate or placebo

Intervention Type: DRUG

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

Interventions

Creatine monohydrate or placebo

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

Intervention Type: DRUG

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."

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Perry Renshaw

OTHER

Sponsor Role: lead

Responsible Party

Perry Renshaw

MD, PhD, MBA

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Douglas Kondo, MD

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

University of Utah

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

00055231

Identifier Type: -

Identifier Source: org_study_id