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Clinical Studies

Table of Contents


Clinical Intervention/Pharmacotherapy Core

The goal of the Pharmacotherapy Unit is to create an infrastructure and, subsequently, conduct novel psychopharmacologic interventions for improving the functional outcome of patients with schizophrenia.

Effects of Dialectical Behavioral Therapy and Escitalopram on Impulsive Aggression, Affective Instability, and Cognitive Processing in Borderline Personality Disorder

Marianne Goodman, MD

This study investigates the effects of pharmacologic and psychotherapy treatment on three core biological factors that predispose an individual to borderline personality disorder (BPD): impulsive aggression, lability of affect, and cognitive processing. Forty-two subjects with BPD are currently receiving dialectical behavioral therapy (DBT), and were randomized to six months of treatment with either escitalopram or placebo. DBT is an empirically validated treatment modality for this population. Treatment effects on impulsivity, aggression, cognitive processing, and affective instability are being measured by a variety of modalities including assessment thorough clinical/self ratings, analogue laboratory tasks, and psychophysiologic measures. We are unaware of any study on BPD to date that includes biological outcome measures for DBT treatment or compares efficacy of combined treatment strategies.

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Neurobiology of Affective Instability in Veterans at Low and High Risk for Suicide

Erin Hazlett, PhD

Recent studies indicate that veterans exhibit higher suicide risk compared with the general U.S. population. Despite progress in understanding risk factors for suicidal behavior, the pathogenesis is poorly understood, including alterations in the neural circuitry underlying affective instability (AI) which is associated with suicidal behavior. In order to provide new targets for prevention interventions, it is important to understand what patterns of brain activity may lead to increased risk for suicide. This longitudinal study will inform our understanding of the neurobiology of suicidal behavior and determine whether a promising non-verbal, low-cost psychophysiological measure (affective startle modulation) predicts future suicidal behavior. Specifically, we aim to assess AI in four groups of Veterans (healthy controls, non-suicidal psychiatric controls, suicidal ideators, and suicide attempters) using self-report, psychophysiology, and neuroimaging (fMRI). Understanding the biology of suicidal behavior and prospectively identifying those at greatest risk has clear public health impact.

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High Risk Suicidal Veterans - Predictors of Suicide Risk and Efficacy of Dialectical Behavior Therapy

Marianne Goodman, MD, et al.

Funded by the Department of Defense, this large randomized controlled trial (RCT) compares treatments for Veterans recently discharged from psychiatric hospitalization for high-risk (HR) suicidal behavior. Outcomes for Veterans receiving treatment-as-usual (TAU) will be compared with outcomes for Veterans who receive 6 months of Dialectical Behavior Therapy (DBT), consisting of weekly individual sessions, skills training group and telephone coaching as needed. Whether assigned to DBT or TAU, each participating Veteran also will continue to receive standard outpatient clinic services including psychopharmacology and case management.

     To measure change over time, the 120 participating Veterans will complete assessments at months 6, 12 and 18. The primary treatment outcome will be a quantification of suicidal events, as assessed by the Columbia Suicide Severity Rating Scale, which measures suicide attempts, plans and preparations. Secondary outcomes will include suicidal ideation, para-suicidal events, treatment adherence, depressed mood, substance abuse and hopelessness.             

     Following a baseline assessment to determine suicide risk, the study also will compare 150 HR Veterans to 150 low-risk Veterans on a series of interpersonal and resiliency measures. In addition, the HR Veterans will undergo a comprehensive diagnostic interview prior to entering the treatment study. In this manner, the investigators expect to identify intermediate symptoms that are closely associated with HR suicidal behavior. Data collection is near completion and results should be available after April, 2014.

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Impact of Clozapine

Bruce Levine, MD

The purpose of this project is to determine the impact of Clozapine on the symptoms and recovery of the SMI outpatients in VISN 3. SMI outpatients eligible for a switch to Clozapine include all patients who have been tried on two antipsychotics for an adequate dose and time. These antipsychotics must be one second generation antipsychotic plus one other antipsychotic, either first or second generation. All patients currently taking more than one antipsychotic are also considered eligible. Rehospitalization within same year of discharge, continued impairment from positive or negative symptoms, high utilization of emergency services without rehospitalization, high utilization of ICM times, noncompliance because of side effects of other medications, and tardive dyskinesia are the clinical determinants that the patient is not doing well on his/her current regimen.

We will focus on the effectiveness of Clozapine among treatment refractory outpatients as compared to patients on multiple antipsychotics. These patients will then be followed for community tenure, rehospitalizations, use of emergency services, deaths, other adverse medical events, level of restriction of living situation, sheltered work, competitive employment, and aggressive or suicidal incidents. Outcomes will then be compared. We hypothesize that Clozapine will decrease adverse advents and increase the indicators of symptom amelioration and recovery.

Outcomes will be measured initially by patients’ medication regimens. Patients who remain on Clozapine alone until the end of the study will be viewed as treatment successes. Likewise, patients in the stay group who remain on their original regimens will indicate a positive treatment outcome. Measures of outcome will involve administrative data such as rehospitalizations, use of emergency services, deaths and adverse medical events, readmissions to other non-community treatment settings, and measures of psychiatric symptomatology including the Positive and Negative Symptom Scale (PANSS, a measure of functioning and quality of life) and the Abnormal Involuntary Movement Scale (AIMS). We will also be looking at the rate of switch to Clozapine in the treatment as usual group compared to historical rates.

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4-Aminopyridine in Schizophrenia and Schizoaffective Disorder

Bill Byne, MD

The purpose of this pilot study is to evaluate the tolerability and safety of Ampyra (Dalfampridine Extended Release) as an add-on to the existing pharmacological regimens of psychiatrically stable subjects with Schizophrenia and Schizoaffective disorder. This is an Open Label trial.

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Biological Correlates of Psychotic Spectrum Disorders

Bill Byne, MD

This is an umbrella protocol designed to create a registry of well characterized subjects with psychotic-spectrum disorders. Such a registry will facilitate recruitment of subjects into individual studies investigating the biological dimensions of these disorders.

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Selecting Best Neuroleptic Treatment for Veterans with Schizophrenia (VA Merit)

Erin Hazlett, PhD

The primary objective of this study is to begin to identify potential biomarkers for predicting response to antipsychotic treatment in individuals diagnosed with Schizophrenia or Schizoaffective Disorder. Participating Veterans with these diagnoses take part in a 4-week treatment trial of risperidone. All participants receive a structured diagnostic interview with a clinical psychologist, an EKG, standard blood and urine toxicology screens, 4 weeks of risperidone treatment with weekly visits for assessments with two JJPVAMC psychiatrists, a MRI scan, and psychophysiological testing pre- and post- risperidone treatment. Biomarkers of particular interest in this study are caudate and sensorimotor gating measures.

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Affective Startle Assessment in High Risk Suicidal Veterans (DoD Supplement)

Erin Hazlett, PhD & Marianne Goodman, MD

This study is the first to use Affective Startle - a validated, reliable, non-verbal psychophysiological measure of emotion processing - specifically to assess for suicidality.  The assessment (at baseline and 6-month follow-up) also includes two self-report measures, one for emotional regulation and the other for dissociation. The sample will include healthy individuals, individuals with suicidal ideation, individuals who have made a single attempt at suicide, and individuals who have made multiple attempts. Veterans who have already consented to participate in another related study (“High Risk Suicidal Behavior in Veterans: Assessment of Predictors and Efficacy of Dialectical Behavioral Therapy,” Protocol # GOO-09-73) are eligible to participate in this study as well. 

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Neuroimaging Predictors of Response to Cognitive Remediation in Schizophrenia (Mt. Sinai CRC funded pilot study)

Erin Hazlett, PhD

This is a pilot study to investigate biological predictors (namely, volume of Brodmann area 10 and 45 and fractional anisotropy of the uncinate fasciculus) of response to a trial of cognitive remediation for individuals with schizophrenia. In this study, Veteran outpatients diagnosed with Schizophrenia undergo (at Mt. Sinai Hospital) a one-time MRI scan and a same-day urine toxicology test. Female participants also receive a pregnancy test.

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Augmentation of Cognitive Remediation with Social Skills Training in the Schizophrenia Spectrum (MIRECC pilot)

Erin Hazlett, PhD & Fiona Graff, PhD

This study addresses the cognitive and social skills deficits experienced by many individuals with Schizophrenia and Schizoaffective Disorder. Its aims are (a) to assess the feasibility of augmenting computerized cognitive rehabilitation therapy (CRT) with a social skills group, and (b) to contribute to knowledge of factors associated with response to CRT.   In biweekly sessions over the course of 7.5 weeks, study participants receive modular CRT and a concurrent social skills group.

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Telehealth Psychophysiology: A Proof-Of-Concept Study for a Portable Platform to Assess Emotion (MIRECC pilot)

Erin Hazlett, PhD

In this study, identical psychophysiology sessions are delivered in two different settings: a psychophysiology laboratory (room GC-03A), and a meeting room (the MIRECC conference room, 6C-19), where a laptop computer and psychophysiology equipment are set up on a mobile cart.  In both settings, the psychophysiology sessions follow the affective startle modulation paradigm used in our ongoing study of affective startle in high-risk Veterans (Department of Defense-funded supplement described above).  The participant looks at pictures displayed on a computer monitor, while the tester measures the participant’s psychophysiological responses (EMG for eyeblink and skin conductance).  All participants in this pilot study are deemed psychiatrically healthy (i.e., no Axis I disorder). Each participant completes two sessions, one in the laboratory and one in the conference room.  The research will compare findings from the two settings to determine whether startle eyeblink amplitude measures are equally reliable in both.

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Psychophysiological Measurement of Emotional Processing in Patients with Bipolar Disorder and Schizophrenia.

Erin Hazlett, PhD

The aim of the study is to characterize potential deficits in emotion processing by measuring affective startle across multiple Axis I diagnoses.  The study sample includes healthy individuals, patients with Bipolar Disorder, and patients with Schizophrenia/Schizoaffective Disorder. Each participant receives a 1-hour psychophysiological testing session utilizing a standard affective startle paradigm.  

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Clinical Intervention/Psychosocial Unit

The clinical intervention/psychosocial unit is designed to understand the impact of novel or underutilized psychosocial interventions on SMI veterans’ outcome in the community. Below are examples of current research and therapeutic programs.

Dialectical Behavioral Therapy and Family Skills Training for Patients with Borderline Personality Disorder and their Family Members

Marianne Goodman, MD, et al.

Dialectical Behavioral therapy (DBT) is a manualized cognitive behavioral treatment approach developed to treat chronically suicidal individuals, many of whom met criteria for Borderline Personality Disorder (BPD). The approach combines behavioral interventions including skills training, exposure, problem solving with cognitive techniques of mindfulness, and stresses the importance of client-therapist connection. The DBT approach has also been successfully adapted to inpatient settings, criminal justice settings, outpatient populations of BPD substance abusers, depressed and suicidal adolescents with BPD or BPD traits, and binge-eating disordered individuals.

Despite the pronounced difficulties in interpersonal relationships inherent in BPD, minimal attention has been paid to couples and family treatment in the literature. We are currently treating subjects with Borderline Personality Disorder and their family memberswith a seven-session course of familyDialectical Behavioral Therapy to examine the impact of family DBTon measures of mood and emotion, aggression, family function, intrafamily conflict tactics and violence, relationship quality and adjustment, and communication patterns. Preliminary data will be available after January 2005.

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