Clinical Research

The Cortical GABA in MDD / Insomnia Study will assess the neurochemical mechanisms underlying insomnia in individuals with and without depression.

The purpose of this study is to understand the neurochemical mechanisms underlying insomnia in individuals with and without depression. We will assess a group with no insomnia and no depression, a group with insomnia without depression, a group with depression without insomnia and a group with depression and insomnia. In this way, we hope to determine whether GABA (Gamma-AminoButyric Acid) abnormalities in MDD (Major Depressive Disorder) are related to insomnia or the mood state.

If you are eligible for the study after an initial screening visit, which may last 2-3 hours, you will be given a wrist activity monitor (actigraph) that you will wear for the next two weeks. This device will provide a continuous record of sleep patterns in the home environment. You will also fill out an accompanying sleep diary self-report of sleep timing, duration, and quality.

If you are taking sleep medications or other psychotropic medications (medications that effect your brain function), we will ask you to stop taking them if you’d like to take part in this study. You will need to be off all such medications for 1- 2 weeks (depending on the medication) prior to completing the sleep diaries and wearing the wrist monitor (visit visit 1a), and for the duration of the research study.

After 2 weeks, you will return the actigraph and accompanying sleep diaries. The study coordinator will review the sleep diary entries and the actigraph. You will be compensated $75 for completing the sleep diaries and wearing the actigraph. If your diary entries and other screening data continue to meet appropriate inclusion/exclusion criteria, you will be scheduled for two nights of home polysomnography (PSG). The first night of PSG will include respiratory recordings to rule out sleep apnea. The second night will be used to assess sleep and obtain data for quantitative EEG analysis and heart rate variability. You will come to the sleep laboratory between 6-8 pm on Night 15 or 29 and the electrodes will be put on. On the morning following Night 15 or 29, you will remove electrodes yourself. Subjects will then return to the laboratory on Night 16 or 30 with the equipment, where the data will be reviewed and it will be determined if you are eligible for the MR phase of the study. You will be compensated $125 for completion of the polysomnography portion of the study.

If you are eligible for the next and final phase of the study, you will have two MR scans at the Neuroimaging Center of McLean Hospital within seven days of completing the second at home polysomnography. You will be compensated $125 dollars for completing both scans. For more information, call Laura at (617) 643-6026, or email at lschoerning@partners.org