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Therapeutic Areas: Psychiatry/Psychology
Disease Category: Depression (Major/Severe)

Trial Information

International Study to Predict Optimised Treatment - in Depression (iSPOT-D) Have you taken antidepressants & wondered if they are really making a difference?

By the year 2020, depression will be the second biggest disease burden (after cardiovascular disease). However, the prescription of antidepressant medication can be difficult because there are no evidence-based guidelines to ensure that people receive the type of medication that they will respond best to.

If you are looking for quality, comprehensive treatment for depression, you may be eligible to participate in a clinical research study involving a new technology that uses EEGs to evaluate individual response to medication. The Center for Healing the Human Spirit is seeking volunteers to participate in iSPOT-D, a research study of response to 3 different antidepressants for Major Depression.

iSPOT-D, the largest international study ever undertaken into Major Depressive Disorder (MDD), aims to find objective biological markers to identify depression and treatment outcomes. The goal of iSPOT-D is to develop a tool that can be easily used by physicians and health care professionals to ensure that those suffering from depression receive the right medication first go.

The Center for Healing the Human Spirit is committed to providing the highest level of care to everyone who participates. If you qualify, your progress throughout the study will be closely monitored by Dr. Barbara A. Cohen, who offers a genuine interest in you and the quality of life you are living. Participants will be given a psychological evaluation, EEG assessment, and study-related laboratory test. This information will provide valuable insight into your depression for both you and your physician. Participation in this study is confidential, and you will be compensated for your time for participating in this study.

The aim of iSPOT-D is to identify brain and body characteristics that can be used to objectively diagnose depression and to predict how an individual patient diagnosed with major depressive disorder will respond to a range of antidepressants.

The brain and body characteristics that we are interested in include brain structure, certain genes, and performance on cognitive tasks that engage brain and body. Our aim is to develop an evidence-based tool using biological information that can be easily used in a clinical setting.

How can this study benefit the service provided by physicians to their patients?

This study will provide:

• Evidence based reports off and on-medication
• Psychological evaluation of the patient
• EEG assessment of the patient
• Quality care and careful monitoring of progress
• Opportunity to help make a difference

What does the study involve for MDD & Control participants?

Potential participants will first be screened over the phone. If you qualify, you will be asked to visit the Center for Healing the Human Spirit once to begin participation in the study and a second time 8 weeks after your first visit. During these 2 visits, you will participate in:

• Clinical Psychological Assessments
• Blood and Urine collection
• Electroencephalography (EEG)
• Neuropsychological Testing

Throughout the study, participants will be monitored for changes in symptoms, medication, medication side-effects, and quality of life via phone calls and online assessments. Participants will be reimbursed for their time of participation in the study.

For MDD participants ONLY:After the initial visit to the center, MDD participants will be randomized to one of three commonly prescribed antidepressants: Sertraline (Zoloft), Escitalopram (Lexapro), or Venlafaxine XR (Effexor XR). Participants will be fully aware and informed about the antidepressant treatment they are prescribed. All treatments will be monitored by Dr. Barbara A. Cohen and your own physician.

You may be able to participate if:

• You meet the DSM-IV criteria for a primary diagnosis of Major Depression Disorder (MDD)
• You have a depression severity (HAM-D) score of > 16
• You are between 18-65 years of age (inclusive)
• You are fluent in English (reading and writing)
• You are willing to provide written and informed consent

You are NOT able to participate if you have presence of:

• Suicidal Ideations (score > 8 in Section C of MINI Plus)
• Bipolar Disorder I-III
• Psychosis
• Post Traumatic Stress Disorder (PTSD)
• Obsessive Compulsive Disorder (OCD)
• Primary Eating Disorders
• ADHD (primary over MDD)
• Anxiety (primary over MDD)
• Axis II Personality Disorders
• Pregnancy, breast-feeding or wish to become pregnant
• Any antidepressant drugs which cannot be washed out prior to participation
• Any previous negative reaction to Lexapro, Zoloft, or Effexor XR
• Any medical condition or neurological disorder that would significantly interfere with assessments
• A severe impairment of vision, hearing or hand movements
• A brain injury or blow to the head that resulted in lost consciousness for 5 minutes
• Recent or current substance dependence on alcohol or drugs (in the past 6 months)
• Participation in another Study within the last 4 months

Barbara A. Cohen, Ph.D., MFT, Principal Investigator and Study Coordinator
Center for Healing the Human Spirit
19528 Ventura Boulevard, #639
Tarzana, CA 91356
Phone: 818-343-1331
Fax: 818-343-1113
EMail: drbarbara@healingthehumanspirit.com

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