Montano MD CV / April 2013

C. Brendan Montano MD

Connecticut Clinical Research

160 West Street, Building 1, Suite A

Cromwell, Connecticut 06416

Phone (860) 632- 0144/Fax (860) 632-7882

e-mail

cell: (860) 301-0760

Education:

1964-1968  College of the Holy Cross-Worcester, MA

BS Major Biology, Minor English

1968-1972  Albany Medical College-Albany, NY

1972-1975  St. Francis Hospital and Medical Center-Hartford, CT

Internal Medicine Residency

-Chief Resident-1975

-Yale University-Resident Rotations in Neurology and

Gastroenterology and Dermatology

Affiliations:

2000-Present Connecticut Clinical Research, Director of Metabolic and Neuropsychiatric Research, Principle Investigator

1976-Present Attending Physician at Middlesex Memorial Hospital, Department of Medicine, Middletown, CT

1978-Present Internal Medicine, Private Practice, Special interest in Preventive Medicine and Mood Disorders, Cromwell, CT

2006-2009 Journal of Clinical Psychiatry for Primary Care: Editorial Board

2006-2010 CME Institute: Board of Directors

1972-2010 Courtesy Privileges St. Francis Hospital, Department of Medicine, Hartford, CT

1991-2004 Director, New Beginnings Weight Management Center, Cromwell, CT

1983-1993 Medical Director at Roncalli Institute, Cromwell Crest Convalescent Facility—Cromwell, CT

1985-1991 New England Heart Center—Medical Director-Manchester, CT

1978- 1985 Assistant Clinical Instructor, University of Connecticut School Of Medicine, Department of Family Practice, Farmington, CT

Publications

Postgraduate Medicine, September 2012, 124(5), Discontinuity in the Transition From Pediatric to Adult Health Care for Patients with Attention-Deficit/Hyperactivity Disorder, ISSN-0032-5481,eISSN-1941-9260

Postgraduate Medicine, May 2011, 123(3), 1-11. Distinguishing Symptoms of ADHD From Other Psychiatric Disorder in the Adult Primary Care Setting. Montano & Weisler. Issn- 0032-5481, eISSN – 1941-9260

Journal of Clinical Psychiatry, July 2011, 72(7), 1008-1015. Optimizing Clinical Outcomes Across Domains of Life in Adolescents and Adults with ADHD. Adler, Mattingly, Montano & Newcorn.

A Dynamic Patient Flow Model to Identify Areas to Improve Awareness and Diagnosis in Adults With Attention Deficit Hyperactivity Disorder; Faraone, Willey, Peterson, Stafford, Montano (pending)

Annals Clinical Psychiatry: Oct-Dec 2008 20(4):187-93 ISSN 1547-3325 “The Effect of

Pain on Outcomes in a Trial of Duloxetine Treatment of Major Depressive

Disorder. Arnold, Meyers, Sunderajan, Montano, Kass, Trivedi, Wohlriech

Medscape CME article: February 5, 2008 “Early to Late Adolescence: Issues and

Challenges in the Management of ADHA” Adesman, Greenberg, Pratt,

Goodman, Montano. Chapter 3 “Optimizing Physician-Patient

Communication in Adolescent ADHD

Archives of Internal Medicine, “Attention Deficit/Hyperactivity Disorder in Adults: A

Survey of Current Practice in Psychiatry and Primary Care”; Faraone,

Spencer, Montano, Beiderman: June 14, 2004; volume164, number 11

pages 1157-1252

Primary Psychiatry, February 2004: Vol 11, No 2, “Treatment of Depression: Recognizing and Improving the Standard of Care” Norman Sussman, MD, Pedro L. Delgado, MD, C. Brendan Montano, MD

Journal Of Clinical Psychiatry, The Diagnosis and treatment of Adult ADHD in Primary Care: 2004 Feb., Vol 65, Supple: 3 18-21.

Journal of Family Practice. 2003 Dec; supple: S9-18 “Response to treatment: Gaining and maintaining remission from depression.” Montano CB, Ashton AK, D’Mello DA, Dantz B, Hefner J, Leon FG, Matson GA, Pradko JF, Sussman N, Winsberg B.

PCC Visuals CME progam# 032-999-03-060-H01September 2003 “ Diagnosing and Treating Attention-Deficit/Hyperactivity Disorder in Adults” Biederman, Adler, Culpepper, Mason, Montano, Murphy, Roth, Spencer, Weiss, Wilens.

Journal of Clinical Psychiatry 63:4 357-366, April 2002 “Prevalence of Sexual Dysfunction among Newer Antidepressants” Clayton AH, Pradko JF, Croft HA, Montano CB, Leadbetter RA, Bolden-Watson C, Bass KA, Donahue RM, Jamerson BD, Metz A.

Medscape CME article 2002 C. Brendan Montano MD, Michael Montano “A New Paradigm for Treating Depression in the Primary Care Setting”

Issues in Depression: Index & Reviews, Editor in Chief, Premier Issue November 1999 volume 1, Number 1, “Depression and Anxiety in the Elderly: Therapeutic Challenges”

Journal of Clinical Psychiatry, Treatment of Depression in Long-Term Care Patients 1999 Volume 60, supplement 20 “Primary Care Issues Related to the Treatment of Depression in Elderly Patients” Montano CB

Managed Care Interface, “The Effect of Panic Disorder in the Managed Care Setting” co-authored with Wayne Katon, M.D. and Richard Hart, M.D. May, 1997

Journal of Clinical Psychiatry, Supplement Managing Depression: New Perspectives December 1994 Volume 55 No. 12 “Recognition and Treatment of Depression in a Primary Care Setting” December, 1994-Vol. 55, No. 12, Montano CB

Connecticut Medical Journal, “Stress Management Program with Biochemical Assay”

Sinatra, Montano, Hatch. July, 1982-Vol.46, No. 7

National Advisory Board and/or CME Consultant/Presenter:

Astra Zeneca, Bayer, GSK, Eli-Lilly, Forest, Ortho-McNiel, Organon,

Roche, Takeda, Wyeth, Shire

Research: Clinical Trial Experience

2013 Shire SPC489-329 A Phase 3, Open-label, Multicenter, 12-month Extension Safety

and Tolerability Study of SPD489 in Combination With an Antidepressant in the

Treatment of Adults with Major Depressive Disorder with Residual Symptoms or Inadequate Response to Prospective Treatment with an Antidepressant.

2012 Shire SPC489-209 A Phase 2, Multicenter, Double-blind Parallel-group,

Randomized Placebo-controlled, Forced dosed titration, Dose-ranging Efficacy

and Safety study of SPC480 in Combination with an Antidepressant in the

Treatment of Adults with Major Depressive Disorder with Inadequate Response Following Treatment with an Antidpressant

2012 Bristol-Myers Squibb, CN160010 A Multicenter, Double- Blind, 58 week

Rollover Study to assess the Safety and Tolerability of BMS-820836 in Patients with Treatment Resistant Major Depression.

2012 Bristol-Myers Squibb, CN162007A Multicenter, Randomized, Double-blind,

Active- Controlled, Comparative, Fixed-Dose, Dose Response Study of the Efficacy and Safety of BMS-820836 in Patients with Treatment Resistant Major Depression

2012 Forest Research Institute, VLZ-MD-01 A Double –Blind, Placebo- and Active-

Controlled, Fixed-Dose Study of Vilazodone in Patiens with Major Depressive Disorder

2012 Forest Research Institute, VLZ-MD-02 A Double-Blind, Placebo- and Active-

Controlled Fixed-Dose Study of Vilazolone in Patients with Major Depressive Disorder

2012 Forest NAC-MD-02 A Multicenter, Open-Label, Single-Arm, Free Tablet

Combination, Long-Term Study to Evaluate the Safety of Nevivolol in Combination with Valsartan in Patients with State 1 or Stage 2 Essential Hypertension

2011 Forest NAC-MD-01 A Mulitcenter, Randomized, Double-blin, Placebo-

Controlled, 8 –Week Study to Evaluate the Safety and Efficacy of Nebivolol and valsartan Given as a Fixed-Dose Combination in Patients with State 1 or 2 Essential Hypertension

2010 Otsuka 31-08-255 A Multicenter, Randomized, Double-blind Study to

Evaluate the Efficacy, Safety and Tolerability of an Oral Aripiprazole/Escitalopram Combination Therapy in Patients With Major

Depressive Disorder

2010 Shire SPD489-205 A Phase 2, Multicenter, Randomized, Double-blind,

Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and

Tolerability of SPD489 in Adults with Clinically Significant, Persistent

Executive Function Impairments (EFE) and Partial or Full Remission of

Recurrent Major Depressive Disorder

2010 Forest LVM MD 04 A Long-Term, Open-label Extension Study of F2695

SR in Adult Patients With Major Depressive Disorder

2010 Forest LVM MD 01 A Double Blind Placebo Controlled Fixed-Dose Study of F2695 SR in Patients With Major Depressive Disorder

2010 Pfizer/Wyeth 3151 A1 4437 A Randomized, Double-Blind, Parallel Group

Study to Compare Discontinuation Symptoms in Abrupt Discontinuation

Versus a 1-week Tapering Regimen in Subjects with Major Depressive

Disorder (MDD) Treated for 24 Weeks with Open-Label 50 mg

Desvenlafazine Succinate Sustained-Release Formulation (DVS SR)

2010 Pfizer/Wyeth 3151 A1 3364 A Multicenter, Parallel-Group, Randomized, 10

Week, Double-Blind, Placebo-Controlled Parallel Group

Study to Compare Discontinuation Symptoms in Abrupt Discontinuation

Versus a 1-week Tapering Regimen in Subjects with Major Depressive

Disorder (MDD) Treated for 24 Weeks with Open-Label 50 mg

Desvenlafazine Succinate Sustained-Release Formulation (DVS SR)

2010 Eli Lilly F1J MC HMGU Duloxetine Versus Placebo in the Acute Treatment

of Patients with Major Depressive Disorder and Associated Painful Physical

Symptoms

2009- 2010 Eli Lilly H6P-MC-HDAY A Study to Assess the Long-Term Efficacy and

Safety of Olanzapone and Fluoxetine Combination Versus Fluoxetine

Treatment-Resistant Depression Signatures

2009-2010 Eli Lilly F1J-US-HMGL A Randomized, Placebo-Controlled Trial of

Duloxetine Added to Nonsteroidal Anti-inflammatory Drugs in Patients with

Knee Pain due to Osteoarthritis who have had Suboptimal Response to

Nonsteroidal Anti-inflammatory Drug Treatment

2009 – 2010Wyeth 3151A1 -3362 A Multicenter Randomized, Double-Blind Placebo-

Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of 2

Fixed Doses (10 and 50mg/day) of DVS SR Tablets in Adult Outpatients

with Major Depressive Disorder.

2009-2010 Forest MLN MD 28 A Multicenter, Randomized , Double-Blind,

Placebo-Controlled switch study To Evaluate The Safety, Tolerability and Efficacy Of Milnacipran In Patients With An Inadequate Response To Duloxetine For the Treatment of Fibromyalgia

2009 Forest MLN MD 27 A Multicenter, Randomized, Open-Label, Controlled

Study to Evaluate the Safety, Tolerability, and Efficacy of Milnacipran

When Added to Pregabalin in the Treatment of Fibromyalgia

2008 Takeda A Randomized, double-Blind, Parallel-Group, Placebo-Controlled,

Fixed –Dose Study Comparing the Efficacy and Safety of 2 Doses of

Lu AA21004 in Acute Treatment of Adults With Generalized Anxiety

Disorder.

2008 Novartis Protocol CSPP100A US07 An 8-week Prospective, Multicenter,

Randomized, Double-Blind, Active Control, Parallel Group Study to

Evaluate the Efficacy and Safety of Aliskiren HCTZ vs Ramipril in Obese

patients (BMI > = 30 ) with Stage 2 Hypertension.

2008- 2009 Eli Lilly Protocol F1J-MC-HMGC Effects of Duloxetine 60mg Once Daily

Versus Placebo in Patients with Chronic Low back Pain

2008- 2009 Eli Lilly Protocol F1J-MC-HMGB Flexible Dosed Duloxetine Versus \

Placebo in the Treatment of Fibromyalgia

2008- 2009 Eli Lilly Protocol F1J-MC-HMEZ An open-Label, Randomized

Comparison of Duloxetine, Pregabalin, and the Combination of Duloxetine

and Gabapentin Among Patients with Inadequate Response to Gabapentin

for the Management of Diabetic Peripheral Neuropathic Pain.

2007-2008 Schwarz Biosciences Protocol SP888 A Parallel, Randomized, Double-

blind, Placebo-Controlled, Multicenter Proof of Concept Trial to Assess the

Efficacy and Safety of two Different Transdermal Doses of Rotigotine in

Subjects with Signs and Symptoms Associated with Fibromyalgia

Syndrome.

2007-2009 Forest/Cypress Protocol MLN-MD-06 A Phase III, Multicenter. Open-

Label, Flexible-Dosing Study of Milnacipran For The Treatment Of

Fibromyalgia.

2007-2008 Forest/Cypress Protocol MLN-MD-03

“A Phase III Pivotol, Multicenter, Double-Blind, Randomized, Placebo-

Controlled Monotherapy Study Of Milnacipran For the Treatment of

Fibromyalgia.”

2007 Eli Lilly F1J-MC-HMEO

Duloxetine Versus Placebo in the Treatment of Chronic Low Back Pain

2007 Wyeth 3151A1-402WW

A Multicenter, Randomized, 8 Week Double Blind Acute Phase Followed

by a 6 Month Continuation Phase (Open Label or Double blind) study to

Evaluate the Efficacy, Safety, and Tolerability of DVS SR Versus

Escitalopram in Postmenopausal Women with Major Depressive Disorder.

2007 Novartis CAGO178A2301E1

An 8 Week, Randomized, Double-Blind, Fixed-Dosage, Placebo-

Controlled, Parallel-Group, Multi-Center Study of the Efficacy, Safety and

Tolerability of Agomelatine 25 and 50 mg in the Treatment of Major

Depressive Disorder (MDD) Followed by a 52 Week Open Label

Extension.

2007 Sanofi Aventis EFC 5582

An Eight-week, Multcenter, Randomized, Double-blind, Placebo-controlled

Study, Evaluating the Efficacy, Safety and Tolerability of Two Fixed Doses

(100mg and 30 Mg Once Daily) of Saredutant in Patients with Generalized

Anxiety Disorder.

2006-2007 Takeda Protocol# 01-05-TL-322OPI-001 “A Multicenter, Randomized,

Double-Blind, Placebo-Controlled Study to Determine the Efficacy and

Safety of the Combination of SYR-322 and Pioglitazone HCI in Subjects

with Type 2 Diabetes.”

2006-2007 Eli Lilly Protocol # F3Z-US-IOOV(a) “ The Durability of Twice-Daily

Insulin Lispro Low Mixture Compared to Once-daily Insulin Glargine

when added to Existing Oral Therapy in Patients with Type 2 Diabetes and

Inadequate Glycemic Control.”

2006-2007 Sanofi Aventis Protocol EFC5116 “An eight –week, double-blind, placebo

controlled, multicenter study with Escitalopram as a positive control,

evaluating the efficacy,, safety, tolerability of a fixed dose of SR58611A in

outpatients with MDD”

2006-2007 Wyeth Protocol 3151A4-327-330 A Multicenter, Randomized, Double-

Blind, Placebo-Controlled, Parallel-Group, Adaptive-Design, Efficacy and

Tolerability Study of 4 Fixed Oral Doses of DVS SR in Adult Outpatients

2006-2007 Wyeth Protocol 00600B1-416-US

Patient Outcomes with Educaiton, Drug Therapy and Support(POETS)

A Multiconeter, Open-Label, Randomized Study to Evalute Depressed

Subjects treated with Venlafaxine Extended Release vs Venlafaxine

Extended Release Plus the Dialogues to Talk Program in a Primary Care

Setting

2006 AstraZeneca Protocol D1448C00005 “ A Multi-Centre, Double-Blind,

Randomized-Withdrawal, Parallel-Group, Placebo-Controlled Phase III

Study of the Efficacy and Safety of Quetiapine Fumarate Sustained

Release (Seroquel SR) as Monotherapy in the Maintenance treatment of

Patients with Major Depressive Disorder Following an Open-Label

Stabilization Period (Amethyst Study)

2006 Aventis Protocol HMR3647A/4019 “ A Randomized, Double-Blind,

Parallel-Group, Multicenter Study to Compare Clinical Health Outcomes

of Telithromycin verses Azithromycin in Outpatients with Community-

Aquired Lower Respiratory Tract Infections”

2005-2006 Predix Pharmaceuticals Protocol PRX-CP-007 “A Randomized, Double

Blind, Placebo Controlled, Multicenter Study To Evaluate The Efficacy,

Safety, and Tolerability Of PRX-0023 In Patients With Generalized

Anxiety Disorder (GAD)

2005-2007 Eli-Lilly Protocol F1J-MC-HMEF(a) “Duloxetine 60/120 mg Versus

Placebo in the Treatment of Fibromyalgia Syndrome”

2004-2005 F. Hoffmann-La Roche LTD Protocol ML 18056 “Prospective, Open-

label, Multi-center, Two-part Study To Investigate Patient Satisfaction

With Monthly Dosed Ibandronate Therapy In Women With

Postmenopausal Osteoporosis Or Osteopenia Transitioned from Once-

Weekly Alendronate Or Risedronate2

2004-2005 F. Hoffmann-La Roche LTD Protocol MA17843 “Randomized, Open-Label,

Multi-Center Study to Investigate Patient Preference on Dosing in Women with

Postmenopausal Osteoporosis Treated with Once-Monthly Ibnadroate and Once-

Weekly Alendronate. A Six-Month, Two-Period Crossover Study”

2003-2004 GSK Protocol AK103091: A Multicenter, Double-Blind Placebo Controlled

Comparison of the Efficacy and Safety of Flexible Dose Extended-Release

Bupropion Hydrochloride (HCI) 300-450 mg/day and Placebo Administrated for

Eight Weeks for the Treatment of Adult Outpatients with Major Depressive

Disorder Including Symptoms of Decreased Energy, Pleasure and Interest.

2003- 2005 Eli-Lilly Protocol F1J-MC-HMBV: Duloxetine Versus Placebo in the Treatment of

2003- 2004 Eli-Lilly Protocol H6K-MC-LVFN: An Open-Label Study to Evaluate the

Efficacy and Safety of Tadalafil Administered “On Demand” to Men of Various Populations with Erectile Dysfunction.

2002- 2005 Eli-Lilly Protocol F1J-US-HMBZ: Open –Label Treatment with Duloxetine Hydrochloride once-Daily dosing for Evaluation of Stabilization Dose in Patients with Major Depression.

2001- 2003 Takeda Protocol 01-00-TL-OPI-506: A Randomized Comparator, Controlled, Double-Blind Study of the Liver Safety of Pioglitazone HCI Versus Glyburide with Metformin and Insulin as Part of Step Therapy in Subjects with Type 2 Diabetes.

2001-2002 Aventis Pharmaceuticals Inc.: Ketek Protocol HMR3647A/3014Telithromycin Randomized, Open-Label, Multicenter Trial of the Safety and Effectiveness of Oral Telithromycin and Amoxicillin/Clavulanic Acid in Outpatients with Respiratory Tract Infections in Usual Care Settings