Principal Investigator: Perry Renshaw
Keywords: Major Depressive Disorder , Child and Adolescent Psychiatry , Creatine , MRI , SSRI Department: Adult Psychiatry
IRB Number: 00073442 Co Investigator: Douglas Kondo
Specialty: Psychiatry, Child and Adolescent, Psychiatry
Sub Specialties: Mood Disorders
Recruitment Status: Completed

Contact Information

Danielle Boxer
danielle.boxer@utah.edu
(385)228-3560

Simple Summary

We think the nutritional supplement creatine may help female teenagers with depression feel better if an SSRI medication is not working to make them feel better on its own. Creatine is a member of a family of chemicals called nucleosides that occur naturally in the human body.Data from studies using creatine to treat adult depression are promising, but we do not know if creatine will benefit adolescents with depression. We think that it will help make SSRI medications work better in the body and may also change the chemicals in the brain. By possibly changing the chemicals in the brain, we hope that female teenagers will feel less depressed.If you are interested in being in the study, we will schedule an appointment for you to meet with our study staff. You will meet with Dr. Kondo, a child psychiatrist, and he will spend a lot of time asking you questions. If you and your parents decide you want to be in the study and Dr. Kondo thinks it is a good idea, you will receive the creatine treatment for free. You will continue to take your SSRI medication, and you will have two MRI brain scans to help us look at changes in chemicals in your brain. The study lasts a total of 11 weeks.

Inclusion Criteria

MAJOR DEPRESSIVE DISORDER SUBJECTS (n=66)

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-IV criteria for 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 >4.

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] [128]. 

HEALTHY COMPARISON SUBJECTS (n=40)

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. Participants must be between the ages of 12 and 21 years.

4. Participants must not meet DSM-IV-TR criteria for a current psychiatric illness or substance use disorder.

5. Participants must have a CDRS-R score <30.

Exclusion Criteria

MAJOR DEPRESSIVE DISORDER SUBJECTS (n=66)

1. Unstable co-morbid medical, neurological, or psychiatric disorder. 

2. Current DSM-IV 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 claustrophobia)

9. History of hypersensitivity to creatine.

10. History of a previous failed therapeutic trial of creatine.

11. Participants may be outpatients or inpatients, but incarcerated persons will be excluded because this study is not approved for "Research Involving Prisoners."

12. More than 2 suicide attempts prior to the screening visit

13. Participants who made a suicide attempt within 6 months prior to the screening visit

HEALTHY COMPARISON SUBJECTS (n=40)

1. Unstable medical or neurological illness.

2. Clinically significant psychiatric or substance use disorder.

3. 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.

4. Participants with a contraindication to MRI/MRS scanning, such as a metallic implant.

Participant Reimbursement

Reimbursement for study participants includes $25 at the screeening visit, $50 at each MRI scan visit, and $20 at each of the 6 weekly visits, for a total of $245.