A Selection of Phase II, III, and IV Multicenter Clinical Trials, and Investigator-Authored, Grant-Subsidized Research Protocols, in Which Dr. Gregory Marsella Was A Principal Investigator

1. "Nefazodone in the treatment of Patients with Chronic Pain." (authored by Dr. Marsella, subsidized by a grant from Bristol-Myers Squibb)
2. "A Double-Blind, Placebo-Controlled, Randomized Clinical Trial of the Efficacy of Sertraline in the treatment of Dysthymia." (authored by Dr. Marsella, subsidized by a grant from Pfizer)
3. "Nefazodone in the treatment of Agitated Geriatric Patients." (authored by Dr. Marsella, subsidized by a grant from Bristol-Myers Squibb)
4. "A Placebo-Controlled Study of Olanzapine Monotreatment in the treatment of Bipolar I Depression." (sponsored by Eli Lilly)
5. "An Open-Label Combination of Olanzapine and Fluoxetine in Major Depressive Disorder." (sponsored by Eli Lilly)
6. "A Twelve-Week, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy and Tolerability of Paroxetine in Patients Suffering from Posttraumatic Stress Disorder (PTSD)." (sponsored by GlaxoSmithKline)
7. "A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of Two Doses of Aripiprazole in the treatment of Hospitalized Patients with Acute Mania." (sponsored by Bristol-Myers Squibb)
8. "An Open-Label Study of Tolerability, Clinical Response, and Satisfaction in Adult Bipolar I Subjects Optimizing Initiation of treatment Using Administration of Dermatological Precautions and Lamictal Titration Packs." (sponsored by GlaxoSmithKline)
9. "A Multi-Center, Open-Label, Long-Term Study of the Safety, Tolerability and Efficacy of Aripiprazole in the Maintenance treatment of Patients with Bipolar Disorders." (sponsored by Bristol-Myers Squibb)
10. "An Open-Label Evaluation of Lamotrigine Versus Carbamapezine, Phenytoin, and Divalproex Sodium as Monotreatment treatment for Epilepsy Patients Who Have Failed a Previous Course of Anti-Epileptic drug treatment." (sponsored by GlaxoSmithKline)
11. "Open-Label Use of Keppra (Levetiracetam) in the treatment of Agitated States in Patients Over 50." (authored by Dr. Marsella, subsidized by a grant from UCB Pharma)
12. "Lilly's Emotional and Physical Symptoms of Depression Study." (sponsored by Eli Lilly)
13. "A Multicenter, Randomized, Open-Label, Parallel-Design Trial to Compare Time to Response in the Symptoms of Anxiety to Concomitant treatment with Niravam and an SSRI or SNRI to treatment with an SSRI or SNRI Alone in Subjects with Generalized Anxiety Disorder or Panic Disorder." (sponsored by Schwarz Pharma)
14. "A Six-Week, Double-Blind, Multicenter, Placebo-Controlled Study Evaluating the Efficacy and Safety of Flexible Doses of Oral Ziprasidone in Outpatients With a Diagnosis of Bipolar I Depression." (sponsored by Pfizer)
15. "An International, Multicenter, Large Simple Trial (LST) to Compare the Cardiovascular Safety of Ziprasidone and Olanzapine in Patients With Schizophrenia." (sponsored by Pfizer)
16. "A Multicenter, Double-Blind Study on the Efficacy and Safety of Aripiprazole in Combination with Lamotrigine in the Long-Term Maintenance treatment of Patients with Bipolar I Disorder with a Recent Manic or Mixed Episode." (sponsored by Bristol-Myers Squibb)
17. "A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study of Aripiprazole Flexibly Dosed in the treatment of Children and Adolescents with Autistic Disorder." (sponsored by Bristol-Myers Squibb)
18. "A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study with Three Fixed Doses of Aripiprazole in the treatment of Children and Adolescents with Autistic Disorder." (sponsored by Bristol-Myers Squibb)
19. "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." (sponsored by Bristol-Myers Squibb)
20. "A Randomized, Multi-Center, Double-Blind, Parallel-Group Study To Compare the Effects of Bifeprunox and Quetiapine on Weight Changes in Stable Schizophrenia Patients." (sponsored by Solvay Pharmaceuticals)
21. "A Multi-Center, Open-Label, Parallel-Group, Randomized, Flexible Dose Study to Evaluate the Safety and Tolerability of Switching From Existing Atypical Antipsychotics to Bifeprunox in Subjects With Schizophrenia or Schizoaffective Disorder." (sponsored by Solvay Pharmaceuticals)
22. "Risperidone in the treatment of Children and Adolescents with Autistic Disorder: A Double-Blind, Placebo-Controlled Study of Efficacy and Safety Followed by an Open-Label Extension Study of Safety." (sponsored by Johnson and Johnson)
23. "A 24-Week, Multicenter, Double-Blind, Randomized, Parallel-Group, Dose Ranging Study of the Efficacy and Safety of Oral Doses of AVE1625 5, 10, and 30 mg and Placebo on top of an Established treatment Regimen of Olanzapine, Risperidone/Paliperidone, Quetiapine or Aripiprazole Monotreatment in the treatment of Cognitive Impairment in Schizophrenia." (sponsored by Sanofi-Aventis)
24. "Best Estimate Diagnosis Used to Evaluate EEG in Association With ADHD in a Multi-Site, Clinical Sample of Children and Adolescents." (sponsored by Lexicor Medical Technology)
25. "A Phase Two, Six-Week, Double-Blind, Placebo-Controlled, Multicenter Trial of Varenicline Tartrate (CP-526,555) for Cognitive Impairment in Subjects with Schizophrenia." (sponsored by Pfizer)
26. "A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Subcutaneous MOA-728 for the treatment of Opioid-Induced Constipation in Subjects With Nonmalignant Pain." (sponsored by Wyeth)
27. "A Multicenter, Open-Label Study to Evaluate the Long-term Safety of Subcutaneous MOA-728 for treatment of Opioid-Induced Constipation in Subjects With Nonmalignant Pain." (sponsored by Wyeth)
28. "An 8-week, Multicenter, Double-blind, Randomized, Parallel-group, Placebo-controlled Study of the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL®) Extended-release in Children and Adolescent Subjects with Bipolar Depression." (sponsored by AstraZeneca)
29. "A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Three-Arm, Parallel Group Study (804P301) to Evaluate the Efficacy and Safety of Oxcarbazepine Extended-Release (OXC XR) (1200 and 2400mg/day) as Adjunctive treatment in Subjects with Refractory Partial Seizures due to Epilepsy on up to Two Concomitant Antiepileptic Medications." (sponsored by Supernus)
30. "A Multicenter, Open-Label, Extension Study to Evaluate the Long-Term Safety and Tolerability of Oxcarbazepine Extended-Release (OXC XR) as Adjunctive treatment in Subjects with Refractory Partial Epilepsy on up to Two Concomitant Antiepileptic Medications." (sponsored by Supernus)
31. "A Six-Month, Multi-Center, Placebo-Controlled, Chronic Migraine treatment Trial with combination Topamax (50-100mg) and either Propranolol or Placebo." (sponsored by the NIH: National Institute of Neurological Disorders and Stroke/National Institutes of Health)
32. "A Double-blind, Placebo-Controlled, Flexible-Dose Study of F2695 SR in Patients With Major Depressive Disorder." (sponsored by Forrest Pharmaceuticals)
33. "A Long Term, Open Label Extension Study of F2695 SR in Adult Patients With Major Depressive Disorder." (sponsored by Forrest Pharmaceuticals)
34. "A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Phase III, Long-Term Safety and Tolerability Study of TC-5214 as an Adjunct to an Antidepressant in Patients with Major Depressive Disorder Who Exhibit an Inadequate response to Antidepressant treatment." (sponsored by Astra Zeneca)
35. "A Randomized Placebo-Controlled, Double-Blind Study of LY2216684 Flexible-Dose 12 to 18 mg Once Daily as Adjunctive treatment for Patients with Major Depressive Disorder Who Are Partial Responders to Selective Serotonin Reuptake Inhibitor treatment." (sponsored by Eli Lilly)
36. "A Phase 3, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Duloxetine-Referenced, Fixed-Dose Study Comparing the Efficacy and Safety of 2 Doses (15 and 20 mg) of Lu AA21004 in Acute treatment of Adults With Major Depressive Disorder." (sponsored by Takeda)
37. "A Phase 3, Long-Term, Open-Label, Flexible-Dose, Extension Study Evaluating the Safety and Tolerability of Lu AA21004 (15 and 20 mg) in Subjects With Major Depressive Disorder." (sponsored by Takeda)

REFERENCES

Furnished upon request

(Version Date 11/10/2012)