Major Depressive Disorder Clinical Trial
Official title:
Placebo-Controlled Dose-Ranging Trial of Creatine Augmentation for Adolescent Females With Treatment-Resistant Major Depressive Disorder: a Magnetic Resonance Spectroscopy Study
Verified date | October 2016 |
Source | University of Utah |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 32 |
Est. completion date | May 2014 |
Est. primary completion date | May 2014 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 13 Years to 21 Years |
Eligibility |
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." |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Utah | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
Perry Renshaw |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 8 weeks | No |
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