Psychiatry Clinical Trials

Emory CIDAR Study: Predictors of Remission in Depression to Individual and Combined Treatments (PReDICT)

Principal Investigator: Helen S. Mayberg, MD; W. Edward Craighead, PhD

Population: Never before treated MDD

Summary: Random assignment to 12 weeks of Cognitive Behavioral Therapy (CBT), duloxetine (Cymbalta), or escitalopram (Lexapro). Patients who do not remit after 12 weeks of treatment will receive another 12 weeks of treatment with the combination of medication and CBT.  Patients benefitting from treatment are eligible to continue to receive treatment for another 18-21 months.

Procedures: Blood draws, functional MRI scan, personality interview, dexamethasone-corticotropin releasing hormone test

Contact:

Treatment-Resistant Depression Study

Principal Investigator: Boadie Dunlop, MD

Population:  Adults aged 18-65 with depression who haven’t responded to at least 1, but no more than 3 antidepressants in their current episode of depression.

Summary: Patients who enroll in this 15 week study will be randomly assigned to receive treatment with either Lexapro, Cymbalta, or the study medication which acts on  serotonin, norepinephrine, and dopamine systems. All patients will be on an active medication at all times.

Procedure: Neuropsychological Testing, blood draws

Contact:

Phenotyping Major Depression with Increased Inflammation

Principal Investigator: Andrew Miller, MD

Population: Patients with Major Depression

Contact:

Cervel repetitive transcranial magnetic stimulation (rTMS) for depression

Principal Investigator: William McDonald, MD

Population: Unipolar depressed patients

Summary:  Patients involved in this study will receive four weeks of open label rTMS with an investigational device.  The total time commitment for the study is approximately three months.

Contact:

Transcranial Direct Current Stimulation (tDCS) for depression

Principal Investigator: William McDonald, MD

Population: Unipolar or bipolar depression

Summary: We are investigating a non-medication treatment for depression.  Patients will receive 4 weeks of double blind treatment followed by 4 weeks of open-label treatment.  The total time commitment is approximately five months.

Contact:

Deep brain stimulation for treatment resistant depression: DBS for TRD

Principal Investigator: Helen S. Mayberg, MD

Population:  Treatment-resistant depression

Summary: DBS for TRD is a neurosurgical intervention for depression resistant to standard interventions, including psychotherapy, medication combinations, and electroconvulsive therapy (ECT). The study requires a long-term commitment, as patients are closely monitored with weekly visits to various study sites 4 weeks prior to surgery and 7 months following surgery. At the end of the 7 month period following surgery, patients are followed for five years via visits every month, 3 months, or 6 months, at the discretion of the study psychiatrists.  

Contact Information:

Behavioral Activation and Fluoxetine for Adolescents with Depression

Principal Investigator: Lorie A. Ritschel, PhD

Population: Adolescents 14-17 with depression

Summary: This study compares a new form of therapy for depression called Behavioral Activation (BA) to the antidepressant medication fluoxetine. Participants in the study are randomized to receive treatment with either BA or fluoxetine for 18 weeks. Another aim of the study is to examine the brain functions of adolescents in both treatment groups. Participants undergo functional Magnetic Resonance Imaging (fMRI) scans before and after treatment.

Procedures: fMRI scans, urine drug screen, questionnaires, interviews

 Contact:

Mechanisms of Depression in Cardiovascular Disease

Principal Investigator: J. Douglas Bremner, MD

Population:  CVD with and without Depression

Summary: The purpose of this study is to address brain mechanisms through which depression increases the risk of death in patients with Coronary Heart Disease. Cardiovascular disease is the most common cause of death in the United States. Depression is a common problem among patients with coronary heart disease (CHD), ranging between 16 and 23% in these patients. Several studies have shown that depression is associated with 4-5-fold increased mortality risk in patients with CHD, which is not explained by disease severity or presence of CHD risk factors. Currently, little is known about the mechanisms by which depression confers an increased risk of death in patients with CHD. Depression has been associated with changes in brain areas that modulate emotion and the capacity to cope with stress, including prefrontal cortex and hippocampus. These brain areas have outputs to the heart which may represent the mechanism for the increased sympathetic activity associated with depression, that in turn confers increased risk for death in CHD patients. Understanding the mechanism by which depression confers greater risk for sudden death in patients with CHD has important treatment implications, for example treatment of depression with medications that act on these brain areas may actually prevent sudden death from cardiac events.

Contact:

Pregnancy and Newborn Follow-up Study

Principal Investigator: Katrina Johnson, PhD (Sponsor: D. Jeff Newport, MD)

Population:  Pregnant women with a lifetime diagnosis of unipolar depression (may be currently euthymic or depressed) and pregnant women with no lifetime Axis I disorder.

Summary: Patients will be seen 3 times during pregnancy, ideally at 18, 24 and 36 weeks. The initial screening visit lasts about 2 hours and the remaining prenatal visits last about 1 hour.  Mothers and their newborns will be seen 1-2 weeks postpartum. 

Procedure: Prenatal visits will include a diagnostic assessment and measures of mood, stress, and health behaviors.  Newborns will have a neurobehavioral exam and 15-minute non-sedated MRI at Egleston.

Contact:

Genomic Psychiatry Cohort (GPC): Genomic Parsing of Bipolar Disorder and Schizophrenia: Studies of Large Cohorts in the U.S. 

Principal Investigator: Mark. H. Rapaport, MD

Population:  Normal “controls” as well as individuals with a history of schizophrenia, bipolar disorder, or schizoaffective disorder and their families.

Summary:  Our investigation explores the genetic influences of the aforementioned disorders in the Atlanta population using a short screener, a diagnostic interview, and blood-derived genetic analyses.  

Two cohorts: The first cohort (Cases) will be interviewed for 2 hours. The second cohort (controls) will be interviewed for 45 minutes. See inclusion criteria for definition of cases and controls. A small amount of blood will be taken from both cohorts. 

Contact:

TAKEDA 201 – Bipolar I Depression 

PI: Rakofsky

Summary: Testing the safety and efficacy of TAK-375 (Ramelteon) at 3 different doses or placebo for treatment of depressive episodes in Bipolar I Disorder.  (sublingual version of Rozerem, sleep medicine)

Contact:

TAKEDA 203 – Bipolar I Maintenance (stable)

PI: Rakofsky

Summary: Testing the safety and efficacy of TAK-375 (Ramelteon) at 3 different doses or placebo as an adjunctive therapy of Bipolar I Disorder over a 9 month period.  (sublingual version of Rozerem, a sleep medicine)

Contact:

Transcranial Direct Current Stimulation (tDCS) for depression

PI: William McDonald, MD

Population: Unipolar or Bipolar depression

Summary: We are investigating a non-medication treatment for depression.  Patients will receive 4 weeks of double blind treatment followed by 4 weeks of open-label treatment.  The total time commitment is approximately five months.

Contact:

e-CAeSAR:  Evaluation of a Cognitively Adaptive e-treatment in Schizophrenia-diagnosed Adults:  A Remediation-based Approach

PI: Erica Duncan, MD

Summary: The purpose of this research study is to see if a computerized cognitive remediation program may help improve information processing in patients with a diagnosis of schizophrenia.  Patients will be randomized to either the cognitive computer task or a control task.  Treatment will consist of five 1-hour sessions, conducted 4-5 days per week for 6 months.  In addition there is a screening visit (approx 3 hours), plus a baseline, midpoint and endpoint visit, each of which will take approximately 3 hours.

Contact:

Molly Fargotstein

404-321-6111, ext 6967

Genomic Psychiatry Cohort (GPC): Genomic Parsing of Bipolar Disorder and Schizophrenia: Studies of Large Cohorts in the U.S. 

Principal Investigator: Mark. H. Rapaport, MD

Population:  Normal “controls” as well as individuals with a history of schizophrenia, bipolar disorder, or schizoaffective disorder and their families.

Summary:  Our investigation explores the genetic influences of the aforementioned disorders in the Atlanta population using a short screener, a diagnostic interview, and blood-derived genetic analyses.  

Two cohorts: The first cohort (Cases) will be interviewed for 2 hours. The second cohort (controls) will be interviewed for 45 minutes. See inclusion criteria for definition of cases and controls. A small amount of blood will be taken from both cohorts. 

Contact:

BraveHeart: Welcome Back Veterans Southeast Initiative (www.braveheartveterans.org)

Principal Investigator: Barbara Rothbaum

Population: Veterans of the wars in Iraq (Operation Iraqi Freedom) and/or Afghanistan (Operation Enduring Freedom) with Posttraumatic Stress Disorder

Summary:  This study is designed to help Veterans and their families find resources and treatment for PTSD.  We will provide information and assistance to Veterans who call directly or access our website.  Also we provide a range of treatment options for Veterans with PTSD including 9 sessions of either virtual reality exposure therapy, prolonged imaginal exposure therapy (provided at Emory or vie telemedicine), eye movement desensitization and reprocessing, or cognitive behavioral couples therapy. 

Contact:

Community-Based Telemedicine to Reduce Risk to Georgia Veterans with PTSD

Principal Investigator: Barbara O. Rothbaum, PhD

Summary: Veterans seeking treatment through our BraveHeart: Welcome Back Veterans Southeast Initiative now have the ability to access therapy via telemedicine. In collaboration with the Georgia Partnership for Telehealth, the clinical care coordinator and Veteran will identify a convenient location for him/her to access telemedicine technology and schedule up to 9 weekly appointments with a therapist trained in the delivery of exposure therapy.

Procedures:  Completion of questionnaires and forms with the clinical care coordinator and secure video conferencing with doctors and health care professionals.

Contact: Robin Gross

Phone (TARP line): 404-712-8300

Email: regross@emory.edu.

Patients can also go to: braveheartveterans.org

A Cognitive Enhancer May Facilitate Behavioral Exposure Therapy for PTSD

Principal Investigator: Barbara Rothbaum

Population: Veterans of the wars in Iraq (Operation Iraqi Freedom) and/or Afghanistan (Operation Enduring Freedom) with Posttraumatic Stress Disorder

Summary:  The purpose of this study is to determine whether the combination of virtual reality exposure with D-cycloserine will provide additional benefits in reducing PTSD symptoms when compared to being combined with an anti-anxiety medication (alprazolam, or Xanax) or with a pill placebo. Participants will receive individual virtual reality exposure therapy sessions (6 sessions total, 5 of the VRE). Participants will be evaluated pre- and post-treatment and at a 3, 6 and 12 month follow-up visits to assess long term effects.

Contact:

Grady WITT (Women with Interpersonal Trauma Treatment)

Principal Investigator: Nadine Kaslow, PhD

Population: Women with PTSD

Summary: Grady WITT is an investigation of an individual psychotherapy treatment (STAIR/NST) for women with Post-Traumatic Stress Disorder (PTSD) due to interpersonal violence in childhood or adulthood.  Does not have to already be diagnosed with PTSD (we will assess this ourselves).  The control group will also get therapy.

Contact:

Grady Nia Project

Principal Investigator: Nadine Kaslow, PhD, ABPP

Population: African American women with recent suicide attempt and recent domestic violence

Summary: The Grady Nia Project is a long-running series of studies with African American women who have a history of domestic violence and suicidality.  In addition to the research project, there are support groups for domestic violence and suicide that women who are not eligible for the research project may be referred to.  Women who are interested may also receive individual therapy.

Post-traumatic Stress Disorder (PTSD) in Women: Evaluating the Efficacy of CRF1 Antagonist GSK561679

Principal Investigator: Boadie Dunlop, MD

Population: Women aged 18-65 with Post-traumatic stress disorder (PTSD)

Treatment: Eligible patients will receive 6 weeks of treatment with either a CRF1 (Corticotropin-Releasing Factor type 1) receptor antagonist (GSK561679) or placebo (1:1 randomization), followed by one month of follow-up care.

Procedure: Startle testing; neuropsychological testing, blood draws

Contact:

A Multisite, Randomized, Controlled Trial of Mindfulness Meditation Therapy for PTSD

Principal Investigator: J. Douglas Bremner, MD

Population: Veterans

Summary: The purpose of this study is to evaluate the therapeutic effects, safety, tolerability, and acceptability of mindfulness based stress reduction (MBSR) meditation compared to present centered group therapy (PCGT) in the treatment of posttraumatic stress disorder (PTSD).

Both groups meet once a week for 8 weeks in sessions of 90 minutes. Participation lasts about 3 months with a follow up visit 8 weeks after treatment. Screening/assessment, physical exam, mood/behavior questionnaires, routine lab work and salivary cortisol collection kits will be administered.

Contact:

Neural Circuits in Women with Abuse and PTSD

Principal Investigator: J. Douglas Bremner, MD

Population: Women with childhood sexual abuse with or without PTSD

Summary: Early childhood sexual abuse is an important public health problem that affects 16% of women before their 18th birthday and leads to chronic symptoms of posttraumatic stress disorder (PTSD) in as many as a third of women. Preclinical and clinical research has established a network of brain regions that are sensitive to stress and mediate PTSD symptoms, including decreased function in the hippocampus and anterior cingulate/medial prefrontal cortex, and increased function in the amygdala.

Contact:

Efficacy of Massage and Touch Therapy for the Treatment of Generalized Anxiety Disorder 

Principal Investigator: Mark H. Rapaport, MD

Population:  60 (30 male & 30 female) meeting inclusion / exclusion criteria

Summary: The purpose of this study is to study the 1) the efficacy of 6 weeks of Swedish massage therapy vs. light touch on standardized measures of anxiety 2) the differential efficacy of 6 weeks vs. 12 weeks of Swedish massage for patients with GAD, 3) the biological effects of massage therapy on subjects with GAD. If a subject is eligible, he/she will be randomized to one of two treatment groups: a) 6 weeks of twice-a-week light touch, followed by 6 weeks of twice-a-week Swedish massage or b) 12 weeks of twice-a-week Swedish massage.

Contact:

Fear of Flying treatment with Virtual Reality Exposure Therapy

Principal Investigator: Barbara O. Rothbaum, PhD

Population: Men and women between the ages of 21 and 65 that have flown at least once and have a fear of flying

Summary: Our study will last 8 weeks and will implement the use of a leading treatment for fear of flying:  Virtual Reality Exposure (VRE) therapy.

Contact: Robin Gross

Phone (TARP Line): 404-712-8300

Email: regross@emory.edu

Understanding Personality: Helping Therapists Better Understand their Patients

Principal investigator: Drew Westen, Ph.D.

Population:  Psychotherapy patients with clinically significant eating pathology (anorexia, bulimia, binge eating disorder) and their therapists.

Summary:  Patient participants who enroll will come to Emory psychology offices on two separate days for roughly 2-4 hour interviews asking about life experiences, relationships, and personality. On one of those days (or on a separate occasion, if preferred), participants will be asked to provide a saliva DNA sample and will also complete a number of questionnaires and some brief computer tasks. Participants’ therapists will be asked to complete about 1 hour’s worth of questionnaires describing the participant and their personality. We will also ask participants to provide names and contact information for a few family members and friend who know them well and may be willing to complete some brief questionnaires about the participant. Finally, after 18 months, we will again contact participants to come in for a brief follow-up visit.

Procedure: Clinical interviews, questionnaires, and computer-based tasks.

Contact:

Grady CAMP

Principle Investigator: Nadine Kaslow, PhD, ABPP

Population: African American men and women with recent suicide attempts

Summary: Grady CAMP investigates a 6-week group compassion meditation treatment for African American men and women who have recently attempted suicide.  Those in the control condition are enrolled in a suicide support group.  Participants who are interested may also enroll in individual therapy.

 Contact:

Grady Nia Project

Principle Investigator: Nadine Kaslow, PhD, ABPP

Population: African American women with recent suicide attempt and recent domestic violence

Summary: The Grady Nia Project is a long-running series of studies with African American women who have a history of domestic violence and suicidality.  In addition to the research project, there are support groups for domestic violence and suicide that women who are not eligible for the research project may be referred to.  Women who are interested may also receive individual therapy.

The current research project involves a 10-week manualized group treatment and access to additional resources.

Emory CALM Study:  Examining the effects of behavioral interventions on emotional well‐being and medical health.

Principle Investigator: Thaddeus Pace, PhD

Population: Medically and psychiatrically healthy participants

Summary: The study will explore whether behavioral interventions affect health and well‐being by improving how the body responds to stress. Two of the interventions include training in meditation. The third intervention will provide education on a number of important health topics in a supportive group environment. The study has two phases.  The first phase will last 12 weeks and will involve completing a number of assessments, and will require two separate visits to the research unit of Emory University Hospital. At each visit, participants will spend one day at the hospital research unit, and will undergo various study procedures that include placement of an IV (intravenous line). Participants will also attend a training class one evening per week for 8 weeks, and will wear a digital audio recorder for 2 weekends.  Phase two is a follow-up period that will occur within six months of completing the first phase.  It will involve completing a number of assessments and wearing a digital audio recorder for a weekend.