Depression at Altitude Study
Female Depression Study Details
We are recruiting females between the ages of 18 - 65 years old who have depression. In order to qualify for the study, you must be taking a selective serotonin reuptake inhibitor (SSRI) or serotonin and norepinephrine reuptake inhibitor (SNRI) antidepressant medication but still not feeling better.
What Is The Name Of The Study?
A randomized, double-blind, placebo-controlled trial of 5-hydroxytryptophan and creatine for SSRI augmentation in treatment resistant depression associated with hypobaric hypoxia in females
What Is Depression?
Depression is often a combination of symptoms that interfere with a person’s everyday life and can prevent a person from functioning normally. Depression can interfere with 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. People suffering from depression are often prescribed antidepressants (e.g. SNRI, SSRI) for treatment. Sometimes these medications do not help.
What is the purpose of the study?
The purpose of the study is to determine if creatine monohydrate and 5-hydroxytryptophan (5-HTP) is effective in reducing depression in women with depression that has not responded to standard treatments. Creatine and 5-HTP are naturally occurring compounds found in the body. We think that it will help make SSRI or SNRI 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 study participants will feel less depressed as a result of participating in the study.
Who Can Be In The Study?
The following criteria must be met to be in the study:
- Diagnosis of depression and currently feeling depressed
- Between the ages of 25 and 40 years
- Currently taking an SSRI or SNRI medication for at least 8 weeks
- Willing to sign a permission form to be in the study.
- You are comfortable with an MRI scan (e.g., not suffer from severe claustrophobia, severe back pain)
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 with our study staff. You will meet with Dr. Kious, a psychiatrist, and he will spend a lot of time asking you questions. If you are eligible and decide you want to be in the study, you will receive the creatine and 5-HTP treatments for free. You will continue to take your SSRI or SNRI 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 adults 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?
If you are eligible and decide to participate in the study, we will take some blood and ask you to give us a urine sample so that we can make sure you are generally healthy before we give you creatine and 5-HTP. If you are eligible and decide that you want to be in the study, you will receive your first brain scan. You will also start taking the study drug each day. We will ask you to come visit with us almost every week for 8 weeks to make sure that you are doing okay while taking creatine and 5-HTP. At the end of eight weeks you will receive your second brain scan.
What Do I Do If I Want To Talk With Someone About The Study?
Feel free to email Mallory Rogers at firstname.lastname@example.org or call us at 801-587-0332