PSYCHIATRY

The Department of Psychiatry provides comprehensive inpatient and outpatient treatment for mental disorders in children, adolescents, and adults. Within the department, the Mood Disorders Research Program at the Research Institute and Case Western Reserve University is one of five Stanley Foundation Bipolar Disorders Clinical Research Centers in the country. The program specializes in early intervention and conducts state-of-the-art research in the treatment of mood disorders in order to help patients lead healthier, more productive lives.

Federally Funded Research Activities

• Service to Others and Long-Term Outcomes [PI: Maria Pagano, Ph.D]

• Best Pharmaceuticals for Children Act Pediatric Off-Patent Drug Study (PODS): Lithium in the Treatment of Pediatric Patients. [PI: Robert L. Findling M.D.]

• Longitudinal Assessment of Manic Symptoms. [PI: Robert L Findling M.D.]

• Bipolar Disorder Across the Life Span [PI: Joseph R. Calabrese, M.D. Co-PI – Robert Findling, M.D.]

• Youth experience of psychotropic treatment [PI: Jerry Floersch, Ph.D. (MSASS) Primary psychopharmacology mentor: R. Findling]

• Divalproex sodium and risperidone in pediatric bipolar disorder. [PI: M. Pavuluri, M.D. Primary pediatric psychopharmacology mentor: R. Findling]

• Child and Adolescent Psychiatry Trials Network - CAPTN [PI: John March M.D. Steering Committee Member – R. Findling]

• Bipolar Disorder, Subjectivity and Treatment Adherence. [PI: Martha Sajatovic, M.D. Co-Mentor: Joseph R. Calabrese, M.D.]

• Acute Pharmacotherapy of Late Life Mania. Site [P.I.: M. Sajatovic, M.D. (Multi-site collaborative U01, central PI: Robert Young M.D.]

• Customized Treatment Adherence Enhancement (CAE) in bipolar disorder. [P.I.: M. Sajatovic, M.D.]

• Lithium Treatment - Moderate Dose Use Study (LiTMUS): A Randomized Controlled Effectiveness Trial Proposal from the Bipolar Trials Network. [Site PI: Joseph R.Calabrese, M.D. (Coordinating PI: Andrew Nierenberg)]

• Bipolar Trials Network (BTN). [Site PI: Joseph R. Calabrese MD (Director: Andrew A. Nierenberg)]

• Side-by-Side Comparison of Blood – Brain Models [PI: George Jaskiw]

• Stimulant and Risperidone for Youth with Aggression [PI: Robert Findling M.D.]

Department of Defense Funded Research Activites

Resilience and Risk Factors Associated With Combat-related Posttraumatic Psychopathology. [P.I.: Joseph R. Calabrese, M.D. (Co-PI: Marijo Tamburrino, M.D. Director of Research Method Core: Sandro Galea, M.D, Ph.D. Director of the Genetics Repository: Israel Liberzon, M.D., Ph.D.)]

Resilience and Risk Factors Associated With Combat-related Posttraumatic Psychopathology. [P.I.: Joseph R. Calabrese, M.D. (Co-PI: Marijo Tamburrino, M.D. Director of Research Method Core: Sandro Galea, M.D, Ph.D. Director of the Genetics Repository: Israel Liberzon, M.D., Ph.D.)]

Veterans' Affairs Funded Research Activities

• A randomized clinical trial of Vitamin E and Memantine in Alzheimer’s disease. [Site PI’s P.J. Chen M.D. (Psychiatry) and M. Pallaki M.D. (Medicine) (Central study PI: Aurice Dysken M.D.)]

• Serotonin 5-HT2 receptor regulation of dopamine release [PI: Elizabeth Pehek Ph.D.]

• Brain Tyrosine Levels Affect Prefrontal Cortex Dopamine. [PI: George Jaskiw MD, Ph.D.]

• Radiotracer Study of Tyrosine as a Precursor for Brain Catecholamines. [PI: George Jaskiw M.D., Ph.D.]

• Glutamatergic Regulation of Amphetamine-Sensitized Reward Seeking PI: [Christine Nocjar, Ph.D.]

• Serotonin-Dopamine Interactions in PET Knock-Out Mice. [PI: Elizabeth Pehek Ph.D.]

• Long-Acting Injectable Risperidone In The Treatment Of Schizophrenia Site [PI: Eric Konicki M.D. (Central Study PI: Rosenheck R)]

• Risperidone Treatment for Military Service Related Chronic Post-Traumatic Stress Disorder Site [PI: Eric Konicki M.D. (Central Study PIs: Krystal J, Rosenheck R)]

State Funded Research Activities

• Ohio Department of Mental Health “Coordinating Centers of Excellence:” Center for Evidence-based Practices (Ohio Substance Abuse/Mental Illness Coordinating Center of Excellence) [PIs: R Ronis (Psychiatry) L. Kola (MSASS)]

• Ohio Department of Mental Health “Coordinating Centers of Excellence:” Center for Evidence-based Practices (Ohio Supported Employment Center of Excellence) [PIs: R Ronis (Psychiatry) L. Kola (MSASS)]

• Ohio Department of Mental Health “Coordinating Centers of Excellence:” Center for Evidence-based Practices (Ohio Advocates for Mental Health/Supported Employment project) [PIs: R Ronis (Psychiatry) L. Kola (MSASS)]

• Ohio Department of Mental Health “Best Practices Institutes:” Center for Evidence based Practices (Tobacco Cessation Center of Excellence) [PIs: R Ronis (Psychiatry) L. Kola (MSASS)]

• Ohio Department of Mental Health “Best Practices Institutes:” Center for Evidence based Practices (Ohio Supported Employment Center of Excellence) [PIs: R Ronis (Psychiatry) L. Kola (MSASS)]

• Ohio Department of Alcohol and Drug Addiction Services: Special funding grant for Ohio SAMI CCOE. [PIs: R. Ronis (Psychiatry) L.Kola (MSASS)]

• Subjective experience of bipolar disorder, treatment adherence and stigma. [P.I.: M. Sajatovic, M.D.]

Training Grant Research Activities

• Research Career Development Institute for Bipolar Disorder. [PI: David Kupfer, M.D. Core Faculty: Joseph Calabrese M.D.]

• Multidisciplinary Clinical Research Training Award. [PI: David Kemp, M.D. (Joseph R. Calabrese, M.D., Primary Mentor, Faramarz Ismail-Beigi, M.D., Ph.D., Secondary Mentor)]

• PAL (Public Academic Liaison Program) for residency training in public and community psychiatry [PI: Robert Ronis M.D.]

• Ohio Department of Mental Health Residency Training Grant: Professors of Public Psychiatry and Mental Health Executive Leadership Program. [PI: Robert Ronis M.D.]

• Ohio Department of Mental Health Residency Training Grant: Forensic Psychiatry Fellowship Training. [PI: Phillip Resnick M.D.]

• Ohio Department of Mental Health Residency Training Grant: All-Ohio Institute on Community Psychiatry. [PI: Robert Ronis M.D.]

Foundation Funded Research Activities

• A Pragmatic Clinical Effectiveness Trial in Multi-morbid Anxious Patients with Bipolar I or II Depression - Focus on the Development of Novel Treatments. [PI: Keming Gao, M.D, Ph.D. Co-PI: David E. Kemp, M.D.]

• Pioglitazone for the Treatment of Bipolar Depression and Metabolic Syndrome, [PI: David Kemp, M.D.]

• Influence of Metabolic syndrome on Treatment Outcomes. [PI: David Kemp, M.D.]

• Research Development Award [PI: David Kemp, M.D. (Primary Mentor: Joseph Calabrese M.D.)]

• Aripiprazole in Children with Mania. [PI: Robert L Findling M.D.]

• Aripiprazole in At-Risk Children with Symptoms of Bipolar Disorder. [PI: Robert Findling M.D.]

• Tyrosine Effects on Brain Indices in Schizophrenia [PI: George Jaskiw MD, Ph.D.]

• Subjective experience of bipolar disorder, treatment adherence and stigma. [Co-Investigator: M. Sajatovic, M.D. P.I.: D. Muzina]

• Mood Disorders among Older Adult Immigrants to the United States: A Systematized Review. [PI: Irena Korobkova M.D. (resident – with Primary Mentor Martha Sajatovic M.D.)]

• Role of brain dynorphin and orexin neuropeptide dysfunction in depression [PI: Christina Nocjar Ph.D.]

• Cortical neurochemical control of reward seeking. [PI: Christine Nocjar Ph.D.]

• Therapeutic Effect of Lithium on Alzheimer’s Disease [PI: Seong Shim M.D.]

• Helping Others and Long-Term Outcomes among Adolescents with Substance Use Disorders [PI: Maria Pagano Ph.D.]

Industry Funded Research Activities

• An Open-Label Study to Evaluate the Safety of Depakote ER in the Treatment of Mania Associated with Bipolar Disorder in Children and Adolescents [Site PI: Robert L. Findling, M.D.]

• A phase III evaluation of the efficacy and safety of CLONICEL® (clonidine HCl sustained release) as add-on to psychostimulant medication vs. psychostimulant alone in the treatment of children and adolescents with attention deficit hyperactivity disorder (ADHD). [Site PI: Robert L Findling M.D.]

• Quetiapine-XR Monotherapy in the Treatment of Major Depressive Disorder with Comorbid Generalized Anxiety Disorder. [PI: Keming Gao MD, Ph.D.; Co-PI: David E. Kemp, M.D.]

• Customized Adherence Enhancement (CAE) among individuals with Bipolar Disorder. [PI: Martha Sajatovic M.D.]

• A 52-Week, Open-Label, Multicenter Study of the Safety and Tolerability of Aripiprazole Flexibly Dosed in the Treatment of Children and Adolescents with Autistic Disorder Site [PI: Robert L Findling, M.D.]

• A Multicenter Double-Blind, Randomized, Placebo-Controlled, Flexible-Dosed, Parallel-Group Study of Aripiprazole Flexibly Dosed in the Treatment of Children and Adolescents with Autistic Disorder Site [PI: Robert L Findling, M.D.]

• Aripiprazole in At-Risk Children with Symptoms of Bipolar Disorder Site [PI: Robert L. Finding M.D.]

• Aripiprazole in Children with Symptoms of Mania Site [PI: Robert L. Findling, M.D.]

• The Cognitive Effects of Aripiprazole on Children Site [PI: Robert L. Findling, M.D.]

• A Multi-center, Double-Blind, Randomized Placebo Controlled, Parallel-Group Study with Three Fixed Doses of Aripiprazole in the Treatment of Children and Adolescents with Autistic Disorder Site [PI: Robert L. Findling M.D.]

• A Double-blind, Fixed-Dose Extension Study of Escitalopram in Pediatric Patients with Major Depressive Disorder Site [PI: Robert L. Findling M.D.]

• A Double-blind Flexible Dose Study of Escitalopram in Pediatric Patients with Major Depressive Disorder [Site PI: Robert L. Findling M.D.]

• Open-label, prospective trial of Lamotrigine for symptoms of geriatric bipolar depression (GERI BD SAD). Multi-site investigator initiated trial. Central study [PI: M. Sajatovic, M.D.]

• An Open-label trial measuring satisfaction and convenience of two formulations of Lamotrigine in subjects with a mood disorder. [Site PI: M. Sajatovic M.D.]

• A Randomized, Multicenter, Double-Blind, Weight-Based, Fixed-Dose, Parallel- Group, Placebo-Controlled Study of the Efficacy and Safety of Extended Release Paliperidone for the Treatment of Schizophrenia in Adolescent Subjects, 12 to 17 Years of Age. [Site PI: Robert L Findling, M.D.]

• A Phase 3, 6-Month, Open-Label Single-Arm Safety Study of Flexibly Dosed Paliperidone Extended Release (1.2 – 12 mg/day) in the Treatment of Adolescents with Schizophrenia. [Site PI: Robert L Findling, M.D.]

• A Randomized, Double-Blind Comparison of Placebo and Atomoxetine Hydrochloride Given Once a Day in Adults with Attention-Deficit/Hyperactivity Disorder: with a Secondary Examination of Impact of Treatment on Family Functioning. [Site PI: Robert L Findling, M.D.]

• Open Label Exploratory Investigation of Minocycline in Adolescents with Obsessive Compulsive Disorder. [Site PI: Robert L Findling, M.D.]

• A Phase III, Randomized, Double-blind, Multi-center, Placebo controlled, Parallel group, Forced Dose Titration, Safety and Efficacy Study of NRP104 in Adults with Attention-Deficit Hyperactivity Disorder (ADHD) [Site PI: Robert L. Findling, M.D.]

• A Multicenter, 10 week Randomized Double-blind Study of Sertraline and Placebo in Children and Adolescents with Posttraumatic Stress Disorder [Site PI: Robert L. Findling, M.D.]

• A Four Week, Double-Blind, Placebo Controlled Phase III Trial Evaluating The Efficacy, Safety And Pharmacokinetics Of Flexible Doses Of Oral Ziprasidone In Children And Adolescents With Bipolar I Disorder (Manic Or Mixed). [Site PI: Robert L. Findling, M.D.]

• 26-Week Open-Label Extension Study Evaluating the Safety and Tolerability of Flexible Doses of Oral Ziprasidone in Children and Adolescents with Bipolar I Disorder (Manic or Mixed). [Site PI: Robert L. Findling, M.D.]

• Six Week, Double-Blind, Placebo-Controlled Phase III Trial Evaluating the Efficacy, Safety and Pharmacokinetics of Flexible Doses of Oral Ziprasidone in Adolescent Subjects with Schizophrenia. [Site PI: Robert L. Findling, M.D.]

• A 26-Week Open-Label Extension Study Evaluating the Safety and Tolerability of Flexible Doses of Oral Ziprasidone in Adolescent Subjects with Schizophrenia. [Site PI: Robert L Findling, M.D.]

• A Phase IIIb, Randomized, Double-Blind, Multi-Center, Parallel-Group, Placebo-Controlled, Dose Optimization Study, Designed to Evaluate the Efficacy and Safety of Methylphenidate Transdermal System (MTS) in Adolescents aged 13-17 years with Attention-Deficit/Hyperactivity Disorder (ADHD). [Site PI: Robert L. Findling, M.D.]

• A Phase IIIb, Long-Term, Open-Label, Multi-Center, Extension Study Designed to Evaluate the Safety of Methylphenidate Transdermal System (MTS) in Adolescents aged 13-17 years with Attention-Deficit/Hyperactivity Disorder (ADHD). [Site PI: Robert L. Findling, M.D.]

• A Prospective, Open-Label, Multi-Center, Dose-Optimization Study Evaluating the Efficacy, Safety, and Tolerability of VyvanseTM 20-70 mg in Children aged 6-12 Diagnosed with ADHD. [Site PI: Robert L. Findling, M.D.]

• A Double-Blind, Randomized, Multi-Center, Flexible Dose Study Evaluating the Efficacy and Safety of SPD503 in Children Aged 6-12 with Symptoms of Oppositionality and a Diagnosis of Attention-Deficit/Hyperactivity Disorder. [Site PI: Robert L Findling, M.D.]

• A Phase IV, Multi-Center, Open-label Study of DaytranaTM (Methylphenidate Transdermal System (MTS)) to Characterize the Dermal Reactions in Pediatric Patients aged 6-12 years with Attention Deficit/Hyperactivity Disorder (ADHD). [Site PI: Robert L. Findling, M.D.]

• A Phase IV, Multi-Center, Open-Label, Safety and Effectiveness Study of Extended-Release Carbamazepine in the Treatment of Mania in Children and Adolescents Aged 10-17 years with Acute Manic or Mixed Bipolar I Disorder. [Site PI: Robert L. Findling M.D.]

• Multicenter, Open-Label, Safety, Tolerability and Pharmacokinetic Study to Evaluate Single Ascending Doses and Subsequent Short-Term Administration of Fixed Doses of Desvelafaxine Succinate Sustained-Release Tablets in the Treatment of Child and Adolescent Outpatients with Major Depressive Disorder Site [PI: Robert L. Findling M.D.]

• A 6-Month, Multicenter, Open-Label, Flexible Dose Study to Evaluate the Safety, Efficacy and Tolerability of Desvenlafaxine Succinate Sustained-Release Tablets in the Treatment of Child and Adolescent Outpatients with Major Depressive Disorder [Site PI: Robert L. Findling M.D.]