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Clinical Trial 3797

Summit, NJ 07901


Study Summary:

DEPRESSION CLINICAL RESEARCH TRIAL

TRDepression3783

Are you depressed? Have you tried antidepressants that just haven't worked?

If your antidepressants have failed, you may be eligible to participate in a clinical research study, a new technology that uses EEGs to find medical treatment specifically for each individual. CNS Response is seeking volunteers for a research study of EEG-guided medication treatment for Major Depression.

WHO IS ELIGIBLE TO PARTICIPATE?

If you meet the following criteria, you may be eligible to participate:

                     You are 18 years of age or older

                     You have a diagnosis of Major Depressive Disorder.

                     You have tried one (1) or more antidepressant regimens without success

If you meet any of the following criteria, you are not eligible to participate:

                     A history of: closed head injury with unconsciousness, cerebral metastasis, cerebrovascular accident;

                     A current diagnosis of seizure disorder, bipolar disorder, schizophrenia, dementia, mental retardation, substance abuse, or major depression with psychotic features;

                     Use of depo-neuroleptics in the last 12 months, or known pregnancy, lactation, or intent to become pregnant during this study.

People who qualify will be offered psychiatric evaluation, medication and study-related laboratory tests at no charge. Participation in this study is confidential and significant compensation will be awarded depending on your level of participation.

I WANT TO LEARN MORE

Learn More about Our Study and Read Our Frequently Asked Questions Below

CNS Response is now conducting a trial on treatment resistant depression NATIONWIDE.

The rEEGSM Testing Process

The rEEGSM process starts with having an EEG, which measures the electrical activity generated by your brain. Electrodes will be placed on your head to record this activity. You will be asked to close your eyes, but stay awake and minimize your muscle movements for 20 minutes. That's it! EEG is a completely safe procedure that has been in use by physicians since the 1920's.

A Study of rEEGSM Guidance In Treatment-Resistant Depression

The process of selecting medications for patients suffering from depression can be extremely challenging. Referenced-EEG (rEEGSM) is a new and patented process that guides the physician in determining individualized treatment for each patient.

Patients are being sought for a clinical research study in conjunction with six academic centers entitled: A Multicenter, Randomized, Blinded, Controlled, Parallel Group Trial to Demonstrate the Efficacy of rEEGSM Guided Pharmacotherapy in Patients with Depression Treatment Failure.

This trial is meant to compare rEEGSM-guided therapy to a recognized standard approach currently in use. Qualified subjects will be placed at random into an rEEGSM-guided medication group or a standard medication treatment group with both groups treated for 12 weeks. All medications used in the study are approved medications in general use. All visits, physical exam, rEEGSM, labs, rating scales and medications are provided at no cost to the patient. There will be compensation for time and travel.

Frequently Asked About rEEGSM Testing

Does it hurt?
No. There is no sensation of any kind.

Will my head be shaved?
No.

Will I be shocked by the electrodes?
No. The instrument only reads your brain's electrical activity.

May I eat before the test?
Yes. You should limit fluid intake 2 hours before the test. Do not drink alcohol for 3 days prior to the test.

How long will it take?
Approximately 45 minutes.

Should I do anything special before the test?
Get a good night's sleep the evening before. On the morning of the test wash your hair thoroughly. Do not use cream rinse or conditioner, hair spray, mousse, etc. These products will make the scalp slick and the electrodes will not stick. Dry your hair completely and do not braid it.

                     No coffee or tea for 15 hours prior to the test.

                     Do not smoke or chew tobacco for 10 hours prior to the test.

Will I be injected with anything?
No. The EEG recording is completely non-invasive.

What about medications?
Follow your physician's instructions and record them on the back of this brochure. You may need to discontinue some or all medications. Unless instructed by your physician, do not take any over the counter medications; i.e. aspirin, antihistamines, ibuprofen, Tylenol, nasal sprays, cough medicine, allergy medication, analgesics, herbs, food supplements, amino acids, etc.

For other questions, please call your physician's office.
If you forget and take any medications, or take street drugs (by any means) or alcohol, the test will need to be cancelled.

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Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.