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Research Studies
Up one levelBelow you will find descriptions of the studies currently being conducted at our laboratory.
Biomarkers of Antidepressant Treatment in Adoloescents with Major Depression
Primary Investigator: Ian A. Cook, M.D. - Major depressive disorder (MDD) is one of the most common, disabling, and costly conditions, and when it arises during childhood or adolescence, the impact on cognitive and emotional development can have long-lasting consequences. Many adolescents with MDD do not respond to an initial trial of an SSRI antidepressant, and the difference between placebo and medication response rates in this age group is often smaller than in trials for adults with MDD. Some adolescents exposed to antidepressant medication experience treatment-emergent suicidal ideation, so the balance of risks and benefits of antidepressants for adolescents may be different than for adults. A biomarker that could help identify which individuals would benefit from pharmacotherapy could aid in the management of MDD in this age group. Since the 1990s, our laboratory has worked to discover and refine physiologic biomarkers based on EEG changes arising in the first week of treatment. Work with our cordance biomarker has been independently replicated by other investigators. As a further refinement, the BRITE-MD trial (Biomarkers for Rapid Identification of Treatment Effectiveness in Major Depression) found that data from a 15 minute office-based EEG could predict 7 week remission with 74% accuracy, superior to clinical and genetic markers. All these trials have excluded individuals under the age of 18, so accuracy of any of our EEG biomarkers in adolescents and children is unknown. This pilot study will enroll 26 adolescents with MDD, age 12-22, and evaluate the performance of two biomarkers, early changes in prefrontal cordance, and the Antidepressant Treatment Response index (ATR) as used in the BRITE-MD trial. Subjects will receive 8 weeks of treatment with fluoxetine, escitalopram or citalopram, with EEG data recorded prior to and serially during treatment. Outcome measures will be symptomatic and functional improvement. We will evaluate the relationship between these physiologic biomarkers and treatment outcome in this new patient population. This project will integrate research efforts now on-going in several components of the Integrative Study Center on Mood Disorders: the Unipolar Depression Research Program, the Laboratory of Brain, Behavior, and Pharmacology, and the Division of Child and Adolescent Psychiatry.
Biomarkers for Outcomes In Late-life Depression (BOLD)
Primary Investigator: Ian A. Cook, MD - Grant #: 1RC1MH088438 Major depressive disorder (MDD) is a common psychiatric illness with high cost to society and individual patients. One reason for the high cost is that most patients endure lengthy and ultimately unsuccessful empiric antidepressant trials before a successful medication is identified by trial-and-error. Care would be improved if a biomarker could determine, early in the course of treatment, whether a particular antidepressant would likely lead to response, remission, or treatment failure. Physicians could rapidly change treatments to an antidepressant which the biomarker indicated would be likely to help the patient. We have identified quantitative electroencephalographic (QEEG) changes that emerge early in the course of treatment with selective serotonin reuptake inhibitors (SSRIs) that appear to predict later response and remission in a general adult patient population. Demographic trends in the United States suggest that improved care for MDD will be essential for a growing number of elderly with late-life depression. While the consequences of prolonged trial-and-error periods to find a successful treatment are particularly inauspicious for elders with late-life depression, this patient group has not been included in the past studies which demonstrated the use of this biomarker approach in a general adult population. We propose a 12-week treatment trial to evaluate a practical biomarker for predicting outcome based on data from the first week of antidepressant treatment, with a focus only on depression in late life (age ≥65).
Evaluation of Low Emission NeoSync EEG Synchronized TMS Technology For the Treatment of Major Depressive Disorder
Primary Investigator: Ian A. Cook, MD: The purpose of this research study is to examine the effects Neosync sTMS therapy in depression for people who have failed at least one antidepressant trial. This study is examining the effects on mood, life functioning and satisfaction, brain chemistry, and brain activity during treatment. The study examines these items in individuals who have depression, who have tried other forms of treatment, and who are seeking new treatment. The study will enroll about 30 subjects at UCLA, and s/he may receive active treatment or sham treatment during your participation. During the 10 week study, the subject will be asked to come in for 30 study visits over six weeks and one study visit at the 10th week. After an initial interview by a physician and a nurse, subjects who are eligible to participate will receive a psychiatric evaluation, a QEEG test to measure brain activity, and their TMS treatment. In addition, subjects will answer questions about their medical and psychiatric history and respond to a variety of psychological and quality of life questionnaires.
Neurophysiologic Predictors of Outcome with rTMS Treatment of Major Depressive Disorder
Primary Investigator: Ian A. Cook, MD - Transcranial magnetic stimulation (TMS) therapy has proven to lead to symptom improvement in many individuals with major depressive disorder (MDD), yet there is heterogeneity in outcome, with some patients showing robust remission and other showing minimal symptom change. Identifying which individuals are likely to benefit from TMS therapy early in the course of treatment would support continued treatment for those predicted to do well, and consideration of alternative treatments for others individuals. This study will test specific hypotheses about the relationships between early neurophysiologic changes and later clinical outcome with TMS treatment.
Personalized Response Indicators of SSRI Effectiveness in Major Depression (PRISE-MD)
Primary Investigator: Ian A. Cook, M.D. - Major depressive disorder (MDD) is a common psychiatric illness with high cost to society and individual patients worldwide, yet treatments chosen under current best practices frequently do not lead to recovery with the initial medication tried; this yields prolonged symptomatic suffering, functional disability, increased risk of relapse, and risk that individuals will abandon treatment efforts altogether. Better outcomes might be possible if a biomarker could guide clinicians in selecting among treatments. This project will examine biomarker predictions of outcome based on quantitative electroencephalographic (QEEG) features that change during a week of exposure to an SSRI antidepressant medication; by allowing clinicians to use treatments more effectively, the use of physiologic biomarker information for guidance could have a significant impact on the management of MDD.
TNS in MDD: Dose Finding
Primary Investigator: Ian A. Cook, MD – Trigeminal nerve stimulation (TNS) therapy is a technique that involves stimulation of the trigeminal nerve by sending a very small electrical signal from electrodes on the surface of the skin, into nerves located in the skin (“transcutaneously”). The trigeminal nerve carries signals to the brain from sensations on the face and in this project it will carry the electrical signal as well. Participants wear an ipod-sized device with electrodes that adhere to the forehead for a certain amount of time throughout the day. In this trial, that period is eight hours a day while sleeping. The primary purpose of this study is to determine whether this treatment is useful in helping to control the symptoms of depression. Another important interest is the safety and patients’ tolerability of the treatment. Two different frequencies will be used to determine which level, if any, is optimal for treatment. Also, an EEG will be recorded on different occasions to determine the treatment’s possible effects on brainwaves. Finally, six monthly checkups following the completion of treatment will provide researchers with an idea of its long-term effects.
TNS in PTSD
Primary Investigator: Ian A. Cook, MD – Trigeminal nerve stimulation (TNS) therapy is a technique that involves stimulation of the trigeminal nerve by sending a very small electrical signal from electrodes on the surface of the skin, into nerves located in the skin (“transcutaneously”). The trigeminal nerve carries signals to the brain from sensations on the face and in this project it will carry the electrical signal as well. Participants wear an ipod-sized device with electrodes that adhere to the forehead for a certain amount of time throughout the day. In this trial, that period is eight hours a day while sleeping. The primary purpose of this study is to determine whether this treatment is useful in helping to control the symptoms of depression and PTSD together. Traditional treatments for depression have been generally unsuccessful in treating concurrent PTSD. The other equally important interest is the safety and patients’ tolerability of the treatment.
