Therapeutics

Donald F. Klein, M.D., Director

ANXIETY DISORDERS CLINIC
Michael R. Liebowitz, M.D., Director
Randall D. Marshall, M.D., Associate Director; Director of Trauma Studies and Services
Carlos Blanco, MJ.D., Assistant Director
Franklin Schneier, M.D., Research Psychiatrist III
Brian A. Fallon, M.D., Psychiatrist II; Director, Lyme Program, Refractory Obsessive Compulsive Disorder Program and Somatic Disorders Program
Roberto Lewis-Fernandez, M.D., Psychiatrist II, Director, Hispanic Treatmjent Program
Helen Blair Simpson, Ph.D., Director, Obsessive Compulsive Program

ANXIETY GENETICS UNIT
Abby J. Fyer, M.D., Director
Josh Lipsitz, Ph.D.

BIOLOGICAL STUDIES UNIT
Laszlo Papp, M.D., Director

DEPRESSION EVALUATION SERVICE
Frederic Quitkin, M.D., Director
Jonathan Stewart, M.D., Research Psychiatrist II
Patrick McGrath, M.D., Research Psychiatrist II
Judith Rabkin, Ph.D., M.P.H., Research Scientist VI
Stephan J. Donovan, M.D., Research Psychiatrist

OVERVIEW
The Department of Therapeutics is composed of four interactive divisions that continue in their endeavors to evaluate, define and treat mood, anxiety and related disorders. As Director of the department, Dr. Donald Klein provides scientific and administrative guidance on methodology, critical evaluation, and future directions of research. Dr. Klein is pursuing studies of the pathophysiology of panic.

A mutual exchange of ideas and techniques among the researchers has provided for growth within each division as well as collaborations within the department and with other departments in the institute. Below, each clinic describes its research projects of the past year.

CURRENT RESEARCH

ANXIETY DISORDERS CLINIC
The Anxiety Disorders Clinic (ADC) is now under the leadership of Drs. Michael R. Liebowitz, Randall Marshall, and Carlos Blanco. The Clinic continues to focus on the advancement of the understanding of the diagnosis, etiology, and treatment of DSM IV anxiety disorders. Dr. Roberto Lewis Fernandez is the Director of the Hispanic Treatment Program. Dr. Brian Fallon is the Director of the Lyme Program, the Refractory Obsessive Compulsive Disorder Program and the Somatic Disorders Program. Dr. Helen Blair Simpson is the Director of the Obsessive Compulsive Program.

Panic Disorder
We are collaborating with Drs. Donald Klein and Smit Sinha on a sleep paradigm to study endogenous CO2 sensitivity and apneic threshold in adult patients with panic disorder and in normal adult controls.

Social Phobia
Dr. Michael Liebowitz is principal investigator of a collaborative R01 with Dr. Richard Heimberg of Temple University, comparing adjunctive cognitive-behavioral therapy to continuation of paroxetine alone, in patients with social phobia who are incomplete responders to a 12-week course of paroxetine. Dr. Franklin Schneier is completing PET imaging studies of dopamine function associated with social phobia, major depression, and traits related to subordinate social status under a K02 Independent Scientist Career Training Grant from NIMH. He is also completing a clinical trial of escitalopram in patients with social phobia and co-morbid major depression, and he is collaborating with Dr. Gerard Bruder using dichotic listening to study hemispheric function in these patients. Dr. Schneier was principal investigator of a clinical trial assessing the efficacy of a novel anticonvulsant, levetiracetam, in the treatment of social phobia. Dr. Schneier is also principal investigator of a study using fMRI to assess eye gaze in patients with social phobia, in collaboration with Dr. Justine Kent and with Dr. Joy Hirsch of the Department of Neurology.

Obsessive-Compulsive Disorder (OCD)
The OCD Program has two goals: to improve current treatments for OCD patients and to help elucidate the neurobiological basis of OCD. To improve current treatments for OCD, Dr. Liebowitz and Dr. Simpson are currently funded by NIMH to study the efficacy of augmenting pharmacotherapy with cognitive-behavioral therapy (CBT) in OCD patients. This is a collaborative project with Dr. Edna Foa’s Center for the Treatment and Study of Anxiety at the University of Pennsylvania. In this 5-year study, OCD patients on serotonin reuptake inhibitors are randomly assigned to receive one of two types of CBT, either exposure or ritual prevention (EX/RP) or stress management therapy (SMT). The goals are to examine the immediate efficacy (i.e, after two months of CBT) and the long-term maintenance of gains (i.e., after 1 year of follow-up) of CBT augmentation. The larger goal of this study is to provide clinicians with novel strategies for treating OCD patients who are only partially responsive to established pharmacotherapeutic agents.

To help elucidate the neurobiological basis of OCD, Dr. Simpson is collaborating with Dr. Marc Laruelle in the Division of Functional Brain Mapping to examine whether there are abnormalities in the serotonergic system in the brains of OCD patients. An initial study examining the serotonin transporter in OCD patients using positron emission tomography (PET) and a novel radiotracer found no differences between OCD patients and healthy controls in limbic and subcortical brain regions (Simpson et al, 2003). A PET study comparing the availability of serotonin receptors in the brains of OCD patients and healthy controls is ongoing. A K23 awarded to Dr. Simpson currently funds the brain-imaging work.

In the spring of 2004, Dr. Fallon and Dr. Simpson began collaboration with Dr. Antonio Montavani, a research psychiatrist from Florence, Italy, who has initiated a study with Dr. Sarah H. Lisanby of the Department of Biological Psychiatry on the effect of transcranial magnetic stimulation as a treatment for OCD.

Hypochondriasis
Dr. Brian Fallon’s work on hypochondriasis was disseminated widely in the press during 2003, with feature articles appearing in many international popular publications including the New Yorker, Time Magazine, and the New Scientist. In addition, new research collaborations are under way with Dr. Arthur Barsky of Harvard University.
Posttraumatic Stress Disorder

Traumatic Grief
Dr. Neria is leading a five-year, web-based, study of the effects of trauma and grief related to the attacks of September 11, 2001. The survey is using a state-of-the-art encryption technology to ensure confidentiality of the participants and is funded by The New York Times and co sponsored by Families of September 11, and the national Center for PTSD.

Center for the Study of Trauma and Resiliency
Drs. Neria and Marshall received the initial donation to create The Center for the Study of Trauma and Resilience that will be the first nonprofit entity solely devoted to state-of-the-art research and education in the area of psychological trauma and its aftermath.

Lyme Disease
Lyme disease research at NYSPI and Columbia continues to produce significant results and continues to receive major funding support from the NIH and private foundations. Ongoing studies address the following areas: brain imaging, cerebrospinal fluid studies, serologic testing, treatment response, relapse prevention, identifying better diagnostic tools. Dr. Fallon continues as chairperson of the International Conference on Lyme Borreliosis. New research studies underway includes the use of proteomics to identify miniscule amounts of borrelial protein, comparison studies of SPECT imaging in Lyme and psychiatric disorders, and the use of MR Spectroscopy to clarify the CNS pathology in Lyme Disease. There has been continued growth in the fund-raising efforts to establish a Lyme Disease Research Center at Columbia as a result of the generous and untiring efforts of the Time for Lyme, Inc Foundation (aka Greenwich Lyme Disease Task Force) and the Lyme Disease Association. Most significant was a fund-raising climb to raise funds for the Columbia Lyme Disease Research Center that led Ken Bacco to attempt to reach the summit of Mount Aconcagua in Argentina in January 2004. Finally, the NINDS funded study of Chronic Lyme Encephalopathy continues to go well. This study will be of pivotal importance in our understanding of Lyme encephalopathy; key collaborators on this project include Dr. Harold Sackeim and his brain imaging team, Dr. Kathy Corbera coordinator of the study, Dr. John Keilp, Dr. Eva Petkova, and members of the Columbia Presbyterian Department of medicine and radiology (Drs. Britton, Dwyer, Dobkin, DelaPaz, Van Heertum). In 2003, Dr. Fallon’s commitment to Lyme Disease Research led to a national award for “a decade of service” from the Lyme Disease Assocation as well as a state award as “best physician” from the California Lyme Disease Association.

Pathological Gambling
Dr. Carlos Blanco is conducting studies on the pathophysiology and treatment of pathological gambling. He is working to make NYSPI a major center for the research and treatment of this prevalent and disabling but little studied condition.

Hispanic Treatment Program
The Hispanic Treatment Program, under the direction of Dr. Roberto Lewis-Fernández, continued to increase its clinical and research activities during this past year. The Washington Heights Primary Care Disaster Project, supported by grants from the Robin Hood Foundation, The New York Times, and the September 11th Fund of the NY Community Trust, carried out clinical treatment and services research among community residents affected by the World Trade Center disaster.

New projects include an industry-sponsored project to test the efficacy of lamotrigine as monotherapy for Hispanic outpatients with co-morbid somatoform and depressive disorders. Future plans include submission of an NIMH grant to improve retention of Hispanic patients in antidepressant therapy, a NARSAD award to develop screening procedures to identify psychosis among urban primary care patients, and a pilot award from the Irving Comprehensive Cancer Center at NYPH to study predictors of treatment delay and non-adherence among minority women with breast cancer.

ANXIETY GENETICS UNIT

The Anxiety Genetics Unit is pursuing both traditional family/linkage studies and neurobiologically based “endophenotypic” and “translational” approaches genetic studies of anxiety. Current family study/linkage based projects include participation in two large collaborative linkage studies: one of panic disorder in collaboration with Dr. Myrna Weissman (Clinical Genetic Epidemiology) and a second of obsessive compulsive disorder in collaboration with Dr. Jim Knowles (NYSPI Molecular Genetics). We are also conducting a NARSAD funded pilot study to assess the potential of an isolate population (Sardinia, Italy) for genetic study of panic, and Dr. Fyer and Dr. Lipsitz are continuing our analyses of our large anxiety disorder family study data base to investigate possible familial subtypes of DSM IV anxiety disorders. The current focus of our endophenotype/translational work is on fear conditioning. We are part of collaborative study in which candidate genes derived from knowledge of molecular biology of fear conditioning mouse models will be tested against variability in human fear conditioning response. This work is being done in collaboration with the Columbia University Genome Center, the Center for Neurobiology and Behavior, and the Division of Clinical Genetic Epidemiology. Our unit conducts the human fear conditioning experiments and is also involved in development of additional human paradigms that may parallel neurobiologically understood animal models, and be of use in translational research approaches.

Dr. Josh Lipsitz has also conducted studies of psychotherapeutic treatment of anxiety disorders and has recently extended his work into evaluation and treatment of anxiety symptoms presenting in medical settings.. He received an NIMH grant to study psychiatric symptoms and psychological distress in children and adolescents with non-cardiac chest pain. The study is recruiting subjects from multiple pediatric cardiology services. Youngsters and parents are assessed with diagnostic interviews and a variety of self-report measures at two time points. Data from this study will set the groundwork for research on interventions with these youngsters.

BIOLOGICAL STUDIES UNIT (BSU)
Under the leadership of Drs. Laszlo Papp and Justine Kent, and in addition to conducting its own research programs, the BSU maintains a centralized research laboratory, serving the need of investigators throughout the Medical Center. Current study sites for the BSU include the Phobia Clinic of North-Shore LIJ Health System, animal facilities of Downstate Medical Center and several clinical departments and basic laboratories within PI and New York Presbyterian Hospital.

Aided by an NIH-sponsored “Core Grants for Enhancing Neuroscience Translation” grant (CoGent) to Dr. Papp, the BSU core also supports a series of pilot projects and provides logistic support to its 10 core grants in mood and anxiety disorders. BSU infrastructure support includes the maintenance of five subject rooms, an examination room and two control rooms on the third floor of PI and the availability of state-of- the-art psychophysiology equipment (e.g. recently modernized fully functional respiratory laboratory, monitoring of cardio-pulmonary functions, facilities needed for collecting and storing biological specimens.)

Research Programs within the BSU
Several projects, sponsored by Industry, are underway to develop and modify respiratory challenges to be utilized in new drug development. Pulmonary testing is also an important aspect of an anxiolytic treatment trial for patients with comorbid anxiety and asthma and of a number of projects conducted in collaboration with the Division of Substance Abuse. Ambulatory monitoring of respiration is currently being validated at the BSU by Drs. Donald Klein and Smit Sinha.

Current treatment protocols with medication and/or psychotherapy are conducted for patients with social anxiety disorder, generalized anxiety disorder and with comorbid anxiety and Irritable Bowel Syndrome.

Dr. Justine Kent, in collaboration with Dr. Jack Gorman, has been carrying out pilot work for a larger study examining the impact of stressful life events and comorbid anxiety on biological markers in depression. This work involves the implementation of protocols using magnetic resonance imaging (MRI) techniques, including morphometric MRI (mMRI), magnetic resonance spectroscopy (MRS), and functional MRI, in the new integrative fMRI Research Center of Columbia University. A major strength of this imaging approach lies in the analysis of cross-modal data that explore questions about the relationship between neurochemistry and function in an integrative manner.

Dr. Kent is also conducting functional imaging studies aimed at delineating the neurocircuitry involved in pathological social anxiety. In March of 2003 she was awarded the Anxiety Disorders Association of America’s Junior Faculty Award.

Drs. Jeremy Coplan and Sanjay Mathew completed an MRS study in patients with generalized anxiety disorder (GAD). Patients with GAD had significantly increased levels of the neuronal marker NAA in the right dorsolateral prefrontal cortex compared to matched controls. They also looked at the effects of paroxetine treatment on MRS measures, particularly N-acetyl-aspartate in the prefrontal cortex and hippocampus. Data analysis for this project in ongoing.

Drs. Coplan and Mathew have been recruiting patients with anxiety disorders for an open label exploratory study of the anti-glutamatergic drug riluzole. They are conducting pre and post treatment MRS, testing the hypothesis that riluzole is anxiolytic by decreasing glutamate excitotoxicity in key brain regions.

The results of the wide-ranging studies at the BSU have been presented during the reporting period at the Annual Meeting of the American Psychiatric Association, the American College of Neuropsychopharmacology, the New Clinical Drug Evaluation Unit and the Anxiety Disorders Association of America.

DEPRESSION EVALUATION SERVICES
Under the direction of Dr. Frederic M. Quitkin, the Depression Evaluation Service (DES) continues to study the first of a new class of antidepressants - gepirone.

The DES continued to participate as a pivotal Regional Coordinating Center for a large NIMH-funded multi-center contract to study treatment-resistant depression called STAR*D (Sequenced Treatment Alternatives for Relief of Depression). Drs. Quitkin, McGrath, and Stewart participated in planning and protocol development for this critical study of treatment effectiveness, which has enrolled over 4,000 subjects nationwide. The study will be the first to test, in a randomized trial of adequate power, the effectiveness of standard treatment strategies for patients who are unresponsive to a first SSRI trial for Major Depression. The results of this trial are expected to have a major impact in informing treatment guidelines for depression.

Both Dr. Stewart and Dr. McGrath continue work on their NARSAD awards. Dr. Stewart, who received his award in September 2001, is investigating mega dose tranylcypromine treatment of refractory depression (i.e., depressed patients who have not improved following several adequate medication trials). In collaboration with Dr. Eric Rubin, Dr. McGrath was funded by NARSAD to conduct a PET imaging study of regional cerebral metabolism in patients who relapse despite continuing antidepressant medication.

Dr. McGrath continues to work on an ancillary study to STAR*D which was funded by NIAAA in 2001 to evaluate the effect of alcohol dependence on antidepressant treatment outcome, using the STAR*D. This study will provide prospective diagnostic data on the over 130 subjects enrolled to estimate the impact of alcohol and drug dependence on outcome in normal clinical treatment settings.

In collaboration with a former fellow in molecular genetics at PI, Dr. Steve Hamilton, Dr. McGrath has conducted studies to delineate genes associated with both response to fluoxetine and intolerance of fluoxetine treatment.

Dr. Jonathan W. Stewart published a paper in which he demonstrated differences in perceptual processing between the same subgroups of atypical depression that also differed in treatment outcome. Further validation of these distinctions would demonstrate that the DSM-IV category of depression with atypical features is a heterogeneous group, and that consideration of age of onset and subsequent course of illness would define more homogeneous groups of patients.

In a retrospective chart review of the likelihood of patients responding to antidepressant medications, Dr. Frederic M. Quitkin discovered that patients at the Depression Evaluation Service have over a 90% chance of remission from their depressive illness if they take three treatments, a marked improvement over the 40-60% remission rate expected for a single antidepressant trial. Dr. Jonathan W. Stewart has begun a prospective pilot study to follow up this finding. Patients will be treated with two medications at once, to see whether more patients benefit, as well as whether combination therapy is well tolerated. As of March 31, 2004, 20 patients had been treated, 16 (80%) responding, again a higher rate than is generally found for a single medication. These results are promising because they demonstrate a treatment approach that results not only in increased benefit over standard treatment, but also, as some patients indicate, may occur earlier.

Dr. Donovan continued his research on pathologic aggression across the developmental spectrum. He has found that the same criteria that predict medication response in adolescence also predict response in children. Since childhood pathologic aggression is a major risk factor for adolescence substance use/abuse/dependence, he is seeking funding to determine whether early treatment can disrupt this pathologic trajectory. He is completing a double blind study of explosive adolescent and young adult marijuana users (funded by the National Institute on Drug Abuse). Results suggest pharmacologic treatment not only reduces irritability but also reduces marijuana use, particularly in the younger subjects. An RO1 and K-O2 received in 2000 has funded these investigations.

HIV Clinical Research Program
Dr. Rabkin’s group continued to enroll patients in an 8-week placebo controlled trial of DHEA for HIV+ patients with mild but persistent depression. To date, 145 patients have been enrolled, and 130 have completed the 8-week trial. An endocrine sub-study, conducted at the Weill Cornell GCRC, included 69 men and 20 women who were assessed both before and at Week 8 of the clinical trial to study the endocrinology of adrenal steroid metabolism.

In an open label trial preliminary data was gathered about the safety and efficacy of modafinil for clinically significant fatigue in HIV+ patients taking antiretroviral medication. Thirty patients were enrolled and all 30 completed the 4-week trial, with an 80% response rate and no change in immunologic/virologic parameters. Of those who completed 12 weeks of treatment, 5 went back to work, 2 others increased their work hours, and 2 enrolled in vocational training. Funding is being sought for a larger placebo controlled trial.

A preliminary open label trial of escitalopram was initiated to treat HIV+ patients with Axis I depressive disorders and cognitive impairment. The research question is whether cognitive performance changes with amelioration of depressive symptoms.

EDUCATION AND TRAINING

Biological Studies Unit
Aided by an NIH-sponsored “Core Grants for Enhancing Neuroscience Translation” grant (CoGent) to Dr. Papp, the BSU core supports a series of pilot projects to young investigators (Drs. Hamilton, Mathew, Kent, and Perera) and provides logistic support to its 10 core grants in mood and anxiety disorders.

CLINICAL SERVICES
BSU infrastructure support includes the maintenance of five subject rooms, an examination room and two control rooms on the third floor of PI and the availability of state-of- the-art psychophysiology equipment (e.g. recently modernized fully functional respiratory laboratory, monitoring of cardio-pulmonary functions, facilities needed for collecting and storing biological specimens.)

AWARDS AND HONORS
• Dr. Donald F. Klein was awarded the “Distinguished Service in Psychiatry Award” by The American College of Psychiatrists.
• Dr. Roberto Lewis-Fernandez was named to the NIMH Services Review Committee and the Community Services Board of the NYC Department of Health and Mental Hygiene.
• Dr. Brian Fallon received a national award for “a decade of service” from the Lyme Disease Association as well as a state award as “best physician” from the California Lyme Disease Association.

GRANTS
MH-067749A1
Donald F. Klein, M.D. is Principal investigator on a new NIMH grant entitled “Psychobiology of IV Naloxone & Lactate in Normals”. Maurice Preter, M.D. is working as the psychiatrist on this study, Ms. Michele Viehl is the clinical rater, and Mr. Emanuel De La Nunez is the research assistant on the grant. The major goal of this project is to test the hypothesis that impairing the endogenous opioid system may render healthy individuals vulnerable to lactate in a fashion similar to the effects of panic disorder.

Anxiety Disorders Clinic

Michael Liebowitz, MD

• CBT Augmentation of Paroxetine for Social Anxiety
• CBT Augmentation of SRI Pharmacotherapy for OCD

Randall Marshall, M.D.

• The NYC Consortium for Effective Trauma Treatment: A Proposal to the New York Times Foundation to Address the Mental Health Needs of Adults, Children, and Families after the World Trade Center Disaster
• The Treatment of Adults with Complicated Grief Reactions: A Training Proposal for Post- 9/11 Greater NY
• Placebo- controlled trial of nefazodone in alcohol-dependent individuals with PTSD

Carlos Blanco, M.D.

• Opioid Dependence and Pathological Gambling
• Screening for Comorbidity in Substance Abuse Clinics
• Treatment of Alcohol dependence with comorbid pathological gambling
• Levels of Care in the Treatment of Depressed Hispanics: Accessibility & Efficacy
• Prolonged Exposure therapy vs. Prolonged Exposure Therapy Combined with Sertraline

Helen Blair Simpson, M.D.

• Improving the Outcome of Patients with OCD

Roberto Lewis- Fernandez, M.D.

• Improving Hispanic Retention in Antidepressant Therapy
• Washington Heights Primary Care Disaster Project
• Assessing Psychosis Screeners Among Undeserved Urban Primary Care Patients
• Improving Mental Health Services Delivered in Primary Care Settings to Hispanic Outpatients Affected by the WTC Disaster
• Training and Consultation- Liaison between academic psychiatrists and Community based PMDs

Franklin Schneier, M.D.

• Imaging of Dopamine D2 Receptors in Major Depression
• A Trial of Levetiractem for the Treatment of Generalized Social Anxiety Disorder
• Escitalopram Treatment of Major Depression and Comorbid Social Anxiety Disorder
• Imaging of the Dopamine System In Social Phobia

Yuval Neria, M.D.

• Posttraumatic Stress Disorder & Prolonged Exposure Therapy: A Training Proposal for Post-9/11 Greater New York
• Understanding September 11 Related Grief

Anxiety Genetics Unit
Clinical Studies of Fear and Anxiety (P.I. AJ Fyer) project grant in NIMH program project “Molecular Genetic Study of Fear and Anxiety” (Program Director TC Gilliam)

An Isolate Population for Genetic Study of Panic Disorder” (P.I. AJ Fyer) NARSAD

Diagnosis and Treatment of Anxiety and Affective Disorders in a General Medical Setting
(P.I. AJ Fyer) Community Trust

Genetic Study of Obsessive-Compulsive Disorder (P.I. JA Knowles, Co-P.I. AJ Fyer) NIMH

Non-Cardiac Chest pain in Children and Adolescents (P.I. J Lipsitz) NIMH

Interpersonal Psychotherapy for Social Phobia (P.I. J Lipsitz) NIMH

Biological Studies Unit
Core Grant to Enhance Neuroscience Transfer (CoGENT) for Mood and Anxiety Disorder Research: Sponsored by NIH

A 3-Part, Double-Blind, Double-Dummy, Parallel-Group, Randomized, Placebo-Controlled Study to Investigate the Effects of L-830982 Immediate Release Formation (Part I) and Lorazepam (Parts I, II, and III) on CO2 Induced Anxiety in Healthy Male Volunteers: Sponsored by Merck & Co., Inc.

A 12-Week Open-Label Followed by a 24-Week Double-Blind Discontinuation Exploratory Study to Evaluate the Effects of Gabitril (tiagabine hydrochloride) in Patients with Social Anxiety Disorder: Sponsored by Cephalon, Inc.

Escitalopram for the Treatment of Patients with Panic Disorder and Comorbid Asthma: Sponsored by Forest Laboratories, Inc.

Keppra (levetiracetam) and CO2 Induced Anxiety in Patients with Panic Disorder:
Sponsored by UCB Pharma, Inc.

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