Adolescent / Young Adult Depression Study
We are recruiting female adolescents between the ages of 12 – 21 years old who have depression. In order to be in the study, you must be taking a selective serotonin reuptake inhibitor (SSRI) antidepressant medication but still not feeling better.
What is the Name of the Study?
Placebo-Controlled Trial of Creatine Augmentation for Adolescent Females with Treatment-Resistant Major Depressive Disorder: a Magnetic Resonance Spectroscopy Study
What is Depression?
Depression is often a combination of symptoms that interfere with your everyday life and can prevent you from functioning normally. Depression can interfere with going to school, sleeping, eating, and enjoying activities. Sometimes depression will occur once in a person’s life, but more often it keeps coming back throughout a person’s life.
Teenagers with depression are often prescribed SSRI medications. Sometimes these medications do not help teenagers with depression feel better.
What is the Study?
We think the nutritional supplement creatine may help female teenagers with depression feel better if an SSRI medication does not work on its own. Creatine is a member of a family of chemicals called nucleosides that occur naturally in the human body. It’s a more natural treatment for depression than some other forms of treatments, like SSRI medications.
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.
Who Can Be in the Study?
You must meet the following criteria to be in the study:
- Diagnosed with depression and currently feeling depressed
- Between the ages of 12 and 21
- Currently taking an SSRI medication for at least 8 weeks
- Willing to sign a permission form to be in the study. If you are younger than 18 years old, a parent or guardian must give permission for you to be in the study.
What Are the Benefits of Being in the Study?
If you are interested in being in the study, we will schedule an appointment for you to meet 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’s a good idea, you will receive the creatine treatment for free. You will continue to take your SSRI medication.
A great benefit to being in the study is that you will have the chance to get your brain scanned. The brain scan does not cause any pain and we hope it will give us a better idea about brain chemistry in teenagers with depression. We will burn a CD with your brain scan on it if you would like.
What Do I Have to Do if I Am in the Study?
First, you will meet with the study staff to decide if it is a good idea for you to participate. If you are younger than 18 years old, one of your parents needs to come with you to the first visit.
If you decide to be in the study, we will take some blood and ask you to give us a urine sample so we can make sure you are healthy before we give you creatine. Once we know you’re healthy, we will schedule a time for you to get your brain scanned. The scan takes about 90 minutes.
After the brain scan, we will give you creatine to start taking. We will ask you to come visit us almost every week for 8 weeks to make sure you are doing okay while taking creatine.
After 8 weeks, you will have another brain scan and we will draw your blood again. After you have stopped taking creatine, we will visit with you once more to see how you are feeling.
What Do I Do if I Want to Talk with Someone About the Study?
Feel free to email Danielle Boxer at firstname.lastname@example.org or call us at 385-228-3560.