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Clinical Research Studies

Dr. Banov participates as a Physician Clinical Investigator (including Principal Investigator) in FDA-regulated clinical research studies on ADHD (attention-deficit/hyperactivity disorder) and other behavioral/psychiatric conditions. Current and recent studies include:

“ A Noninterventional Genotype/Phenotype Study of mGluR Mutations in Children and Adolescents with Attention Deficity Hyperactivity Disorder (ADHD). ”

“ Interventional, randomized, double-blind, placebo-controlled, active reference, fixed-dose study of XXX in pediatric patients age 7-11 with Major Depressive Disorder (MDD). ”

“ Long-term, open-label, flexible dose, extension study of XXX in child and adolescent patients with Major Depressive Disorder (MDD) from 7-18 years of age. ”

“ A Phase 3, Randomized, Double-blind, Multicenter, Placebo-controlled, Forced-dose Titration, Safety and Efficacy Study of XXX in Adults Aged 18-55 years with Attention Deficit Hyperactivity Disorder (ADHD).”

“ A Randomized, sequential parallel, doubled blind, placebo-controlled study for the safety and efficacy of XXX in adults with Attention Deficit Hyperactivity Disorder (ADHD).”

“ A Phase 3, Randomized, Double-blind, Multi-center, Placebo-controlled, Dose-optimization, Safety and Efficacy Study of XXX in Children and Adolescents Aged 6-17 years with Attention-Deficit Hyperactivity Disorder (ADHD).”

“ A Randomized, sequential parallel, doubled blind, placebo-controlled study for the safety and efficacy of XXX in adults with Attention Deficit Hyperactivity Disorder (ADHD).”

“ A Randomized, Double-Blind, Multicenter, Placebo-controlled, Parallel-group, Efficacy and Safety Study of 2 doses of XXX in Adults with Attention Deficit Hyperactivity Syndrome (ADHD)”

“ A Placebo-controlled, double-blind, parallel group, individualized dose study optimizing treatment of adults with attention deficit hyperactivity disorder to an effective response with XXX: the Otter Study. ”

“ A Phase 3, Double-blind, Randomized, Multi-center, Placebo-controlled, Dose-optimization study evaluating the safety, efficacy and tolerability of once-daily dosing with extended release XXX in adolescents aged 13-17 years diagnosed with attention-deficit/hyperactivity disorder (ADHD).”

“ A Phase 3b, Double-blind, Randomized, Active-controlled, Parallel-group Study to compare the time to response of XXX to XXX in Children and Adolescents aged 6-17 years with attention-deficit/hyperactivity disorder (ADHD) who have had an inadequate response to XXX therapy.”

“ A phase 4, randomized, double-blind, active and placebo-controlled, multicenter study evaluating the neuropsychiatric safety and efficacy of 12 weeks of varenicline tartrate 1mg BID and bupropion bydrochloride 150mg for smoking cessation in subjects with and without a history of psychiatric disorders. ”

“ A randomized, double-blind, placebo-controlled, parallel-group, 26-week phase 3 study of 2 doses of an alpha-7 nicotinic acetylcholine receptor agonist or placebo as an adjunctive pro-cognitive treatment in Schizophrenia subjects on chronic stable atypical antipsychotic therapy. 2014 ”

“ A randomized, double-blind, placebo-controlled, parallel, 26-week phase 3 study of 2 doses of an alpha-7 nicotinic acetylcholine receptor agonist or placebo as an adjunctive antipsychotic therapy. 2014. ”

“ A double-blind, placebo-controlled evaluation of the safety and efficacy of XXX in adolescent patients with Major Depressive Disorder. ”

“ A phase III, multi-center, randomized, 24 week, double-blind, parallel-group, placebo-controlled study to evaluate efficacy and safety of XXX in stable patients with persistent, predominant negative symptoms of schizophrenia treated with antipsychotics followed by a 28 week, double-blind treatment period. ”

“ A multi-center, open-label study to access hospitalization rates in adult subjects with schizophrenia treated prospectively for 6 months with XXX compared with 6 month retrospective treatment with oral antipsychotics in a naturalistic community setting in the United States.”

“ A multi-center, randomized, double-blind, placebo-controlled, parallel-group study to investigate the efficacy and safety of XXX versus placebo, as adjunctive therapy in patients with major depressive disorder having inadequate response to ongoing antidepressant treatment.”

“ A multi-center, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of XXX in the treatment of children and adolescent outpatients with major depressive disorder.”

“ A 6-month, open-label, multi-center, flexible dose extension study to the XXX study to evaluate the safety, tolerability, and efficacy of XXX in the treatment of children and adolescent outpatients with major depressive disorder.”

“ A phase three, multi-center, randomized, 6 month double-blind, placebo-controlled study to evaluate the efficacy and safety of XXX as adjunctive treatment in combination with a preexisting antipsychotic treatment in patients with schizophrenia with suboptimal response to antipsychotic treatment.”

“ A multi-center, randomized, double blind, placebo-controlled, parallel group, efficacy and safety study of XXX in the treatment of generalized anxiety disorder (GAD).”

“ A double blind, placebo-controlled study of XXX as adjunctive therapy in major depressive disorder.”

“ A Phase II-b multicenter, randomized, double blind, placebo-controlled efficacy and safety study of adjunctive XXX in subjects with severe major depressive disorder (MDD) and a poor response to antidepressants. ”

“ A Phase 4, Non-Treatment Follow-Up For Cardiac Assessments Following Use of Smoking Cessation Treatments in Subjects With and Without a History of Psychiatric Disorders.”

“ A six week, multi-center, randomized, double blind, placebo-controlled, parallel group study evaluating the efficacy, safety and tolerability of XXX compared to placebo in female subjects diagnosed with major depressive disorder.”

“ A randomized, double blind, placebo-controlled, multi-center study of XXX in patients with opiate dependence.”

“ A prospective, randomized, double-blind placebo-controlled, phase 2 safety and efficacy study of oral XXX as an adjunctive maintenance treatment in patients with Bipolar I disorder. ”

“ A 52 week multi-center, open-label study of XXX tablets in patients with major depressive disorder”

“ A Phase-II-b Multicenter, Randomized, Double-Blind; Placebo controlled, adaptive study of the safety and efficacy of XXX in adults with alcohol dependence. ”

“ A Phase 4, Non-treatment follow-up for Cardiac Assessments following use of smoking cessation treatments in subjects with and without a history of psychiatric disorders. ”

“ An Open-label, Long-term Safety Study of XXX in Pediatric Patients With Major Depressive Disorder. ”

“ A Multicenter, Double-blinde, Placebo and Active-Controlled Parallel-Group Evaluation of the Safety and Efficacy of XXX in Pediatric Patients with Major Depressive Disorder. ”

“ A phase 3, randomized, double-blind, placebo-controlled, parallel-group, multicenter, fixed-dose clinical trial evaluating the efficacy,safety and tolerability of XXX in patients with Bipolar I depression. ”