The Psychobiology of Recovery in Depression-III (PRD-III)

UNIVERSITY OF PITTSBURGH MEDICAL CENTER
WESTERN PSYCHIATRIC INSTITUTE AND CLINIC
DEPRESSION TREATMENT AND RESEARCH PROGRAM
1-888-427-1532.

DEPRESSION Doesn't have to go on, and on, and on ...

Western Psychiatric Institute and Clinic is pleased to announce a research and outpatient treatment program for people who have problems with depression. Our program will help to establish whether people with biological disturbances associated with depression respond differently than those people without biological disturbances. We also will determine if depression can be prevented from coming back by continuing treatment for 16 weeks after recovery.

BENEFITS TO PARTICIPANTS

Without treatment, people who have been depressed are almost certain to remain depressed. All available evidence suggests that most forms of depression are responsive to antidepressant treatment. Everyone who qualifies and participates in this study will receive free outpatient treatment and/or antidepressant medication.

BENEFITS TO THE PUBLIC

Depression can lead to considerable disruption in the lives of those who are depressed and their loved ones. It is hoped that this study will lead to a better system for matching each person with depression to the most effective antidepressant treatment for that individual.

ELIGIBILITY

Men and women between the ages of 18 and 70 who think they may have depression are eligible. Some common symptoms of depression include:

• predominantly depressed mood
• crying easily
• sleep disturbances - extreme fatigue or inability to sleep
• appetite changes
• decreased interest in pleasurable activities
• feelings of worthlessness
• trouble concentrating or remembering

Individuals who want to take part in the study will be interviewed to determine whether they qualify.

COURSE OF TREATMENT

Following a brief screening to confirm eligibility, a three-week evaluation will follow. Participants will then receive 12 weeks of acute outpatient treatment. This treatment consists of weekly counseling sessions along with antidepressant medication and/or a placebo drug.

At the end of twelve weeks of treatment a follow-up evaluation will be conducted. Participants will then receive sixteen additional weeks of outpatient care. Individuals who have depression that is resistant to treatment at the end of the first twelve weeks will be offered alternative antidepressant therapies. At any time, any patient who is not responding to care will be removed from the study and treated free of charge. Our top priority is fostering mental health of our participants.

All antidepressant medications, assessments, and program-related doctors' visits will be provided free of charge to the participant.

During the study, participants will be asked to cooperate with various psychological assessments and ratings. These very important measures help us to determine the biological changes associated with recovery from

Contact Person

For more information on eligibility, please call Susan Berman, BA, at 1-888-427-1532.

Investigators

Michael Thase, MD

John Sweeney, PhD

Edward Friedman, MD

Robert Howland, MD

Roger Haskett, MD

We are conducting a series of short-term studies of the effects of antidepressant treatment for various types of depression.

University of Pittsburgh Medical Center, 200 Lothrop Street, Pittsburgh, PA 15213

The institutions of the University of Pittsburgh Medical Center prohibit and will not engage in discrimination or harassment on the basis of race, color, religion, national origin, ancestry, sex, age, marital status, familial status, sexual orientation, disability, or status as a disabled veteran or a veteran of the Vietnam era. Further, the institutions will continue to support and promote equal employment opportunity, human dignity, and racial, ethnic, and cultural diversity. This policy applies to admissions, employment, and access to and treatment in medical center programs and activities. This is a commitment made by the institutions of the medical center in accordance with federal, state, and/or local laws and regulations.

Study Title: The Psychobiology of Recovery in Depression-III (PRD-III)

Principle Investigator: Michael E. Thase, M.D.

Co-Principal Investigators: John Sweeny, Ph.D., and Edward Friedman, M.D.

Contact Person: Susan Berman, 1-888-427-1532, Project Coordinator

Description of Study:

This study is the third in a series of research protocols which are addressing the psychobiological changes associated with, and predictive of, recovery from depression. Subjects entered into this outpatient protocol will complete assessments of sleep; urinary, and blood cortisol levels; dexamethasone suppression; neurocognitive status; and psychological inventories pre- and post-treatment. Patients are randomized to three treatment cells which are: supportive counseling and sertraline (SRT), supportive counseling and PBO, or Cognitive Behavioral Therapy and PBO. Patients are seen once a week for counseling and/or medication evaluations for twelve weeks. A follow-up phase consists of sixteen weeks of additional outpatient care.

Inclusion Criteria:

1. Males and Females ages 18-60
2. Current diagnosis of nonbipolar, recurrent or single episode major depression by DSM-IV criteria
3. Index episode of less than 2 years duration

Exclusion Criteria:

1. Concurrent DSM-IV diagnosis of anxiety disorders, schizophrenia, schizoaffective disorder, somatization disorder, bipolar, or psychotic subtype of major depression
2. Alcoholism or active drug abuse or addiction within the past 2 years
3. Borderline or antisocial DSM-IV Axis-II diagnoses
4. Medical disorders which may cause depression or require a medication known to be associated with depression: e.g. epilepsy, endocrine disease, cardiovascular disease, hypertension
5. Mental retardation or borderline intellectual functioning
6. Previous failure to respond in the current episode to "adequate" treatment with CBT or SRT

Cost of Treatment:

• NONE

Referral Procedure:

• Call Susan Berman, or the administrative coordinator at 1-888-427-1532, to refer or discuss a patient for this study.

Psychobiology of Recovery in Depression-III

Principal Investigator: Michael E. Thase, M.D.

Introduction and Brief Background. Disturbances of all-night electroencephalographic (EEG) sleep profiles and hypercortisolemia are well-described biological features of major depression. However, the significance of such abnormalities as potential state or trait markers of depressive illness is not fully understood. For example, while available evidence suggests that most types of sleep disturbance tend to normalize with clinical recovery (i.e., state dependent markers), such observations are flawed by the inability to differentiate biologic changes associated with recovery from the direct effect of antidepressants on brain mechanisms. Use of effective nonsomatic treatments of depression, such as cognitive behavioral therapy (CBT), might permit such a differentiation. Selected biological abnormalities also are widely believed to reflect the pathophysiological substrate of severe depressions, and thus may be useful as aids for selection of appropriate treatment modalities. For example, the neurocognitive disturbance associated with hypercortisolism may impair responsiveness to a verbal psychotherapy. If this is true, then abnormal EEG sleep profiles or measures of hypercortisolemia may identify those depressed patients for whom a somatic antidepressant treatment should be provided instead of, or in addition to, psychotherapy.

For the past 7 years, we have employed an EEG sleep assessment/CBT treatment protocol to study these issues. We have found that CBT is an effective treatment for moderate to severe outpatient and inpatient depressions (i.e., a 70% response rate), including some cases with hypercortisolemia and/or EEG sleep features of "biological" depression. Nevertheless, we have collected evidence suggesting that the most severely disturbed patients have significantly poorer outcomes. However, the specificity of these findings for cognitive behavior therapy (vis à vis alternate treatments) is not known. We now wish to extend our studies of this apparent psychobiologic boundary to therapy response by conducting a placebo-controlled clinical trial of an outpatient sample randomly assigned to treatment with supportive clinical management in combination with treatment with either active sertraline (SRT) or inert placebo (PBO) or CBT plus PBO.

Specific Aims. This investigation will pursue 3 specific aims:

1. to characterize psychobiologic correlates of depressive syndromes that are differential to supportive counseling, CBT and pharmacotherapy;
2. to ascertain the relative efficacy of CBT and SRT as compared to counseling and PBO; and
3. to further clarify the state dependence (i.e., reversibility) or state independence (i.e., irreversibility) of selected psychobiologic correlates by studying patients longitudinally.

QUALIFICATIONS OF INVESTIGATORS

Michael Thase, M.D., Professor of Psychiatry and Director of WPIC's Mood Disorders Module, has been actively involved in affective disorders research for the past 13 years. Dr. Thase's research addresses the classification of depressive disorders, neuroendocrine and EEG sleep parameters, and treatment outcome research. He is principal investigator of two NIDA-funded projects, as well as the co-principal investigator of three other NIMH-funded grants.

John A. Sweeney, Ph.D., Assistant Professor of Psychiatry and Neurology. Dr. Sweeney joined our team of investigators in 1991 and has developed the neurocognitive testing battery used in this study. Dr. Sweeney assumes the role of Co-Principal Investigator in the PRD-III protocol. He will be responsible for supervising the assessment components of the study.

Robert H. Howland, M.D., Assistant Professor of Psychiatry in the Mood Disorders Module and an attending psychiatrist on the 11th floor inpatient unit.

Edward Friedman, M.D., Assistant Professor of Psychiatry, Medical Director of the Cognitive Therapy Clinic.

Roger Haskett, M.D., Professor of Psychiatry, Chief of Adult Psychiatry, Western Psychiatric Institute and Clinic.

Drs. Howland and Friedman are experienced clinical psychiatrists and will be the attending physician for the protocol patients. Both have collaborated with Dr. Thase in several prior research protocols. Dr. Haskett will oversee the neuroendocrine component of the psychobiologic studies. This has been his major research interest for over 20 years. Drs. Howland, Friedman, and Haskett have each served as Co-Investigators on several NIMH-funded protocols and have published in the affective disorders literature.

This page was last updated on 01/17/02
If you have any problems with this site please contact the webmaster.
You are visitor number since 01/23/02