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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 multi-center, randomized, placebo-controlled, double blind, parallel group, individualized dosing study optimizing treatment of adults with attention deficit hyperactivity disorder to an effective response with XXX. ”

“ A phase 2, multicenter, randomized, double-blind, active and placebo controlled trial of the safety and efficacy of XXX in the treatment of adult attention Deficit Hyperactivity Disorder. ”

“ A Non-Interventional Genotype/Phenotype study of mGluR mutations in children and adolescents with Attention Deficit Hyperactivity Disorder. ”

“ A Multi-center, 6-week, double-blind, randomized, placebo-controlled, parallel-designed study to assess the efficacy and safety XXX in Adolescents ages 12-17 with genetic disorders impacting metabotropic glutamate receptors and Attention Deficit Hyperactivity Disorder. ”

“ A phase 2, 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 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. ”

“ A randomized, double-blind, multicenter,placebo-controlled, parallel-group, efficacy and safety study of 2 doses of XXX in Adults with Attention Deficit Hyperactivity Disorder. ”

“ 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 Methylphenidate therapy. ”

“ A Phase 3, Double-Blind, Randomized, Multi-center, Placebo-controlled, Dose-optimization Study Evaluating the Safety, Efficacy and Tolerability of once daily dosing with XXX in adolescents aged 13-17 years diagnosed with Attention deficit/Hyperactivity Disorder. ”

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

“ A Phase 2, multi-center, randomized, double-blind, placebo-controlled, adaptive and efficacy of XXX in adults with alcohol dependence. ”

“ A Phase 2b, multi-center, randomized, double-blind, parallel group, placebo and safety study of adjunctive XXX in subjects with severe major depressive disorder ( MDD) and a history of poor response to antidepressants. ”

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

“ A double-blind, placebo-controlled study of XXX as adjunctive therapy in Major Depressive Disorder. ”

“ 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 opioid dependence. ”

“ A 6-month, multicenter, double-blind, randomized, flexible-dose, parallel-group study to compare the efficacy, safety, and tolerability of XXX versus quetiapine extended-release as adjunctive therapy to antidepressants in adult subjects with major depressive disorder who have responded inadequately to antidepressant therapy. ”

“ A 12-week, randomized, double-blind, parallel-group, placebo-controlled, fixed-dosed, multicenter study to evaluate the efficacy, safety, and tolerability of XXX in adults with moderate to severe binge eating disorder. ”

“ A randomized, double-blind, multicenter, active-controlled study to evaluate the efficacy, safety, and tolerability of intranasal XXX plus an oral antidepressant in elderly subjects with treatment-resistant depression. ”

“ A phase 2b, 8-week, double-blind, placebo-controlled, parallel-group study to evaluate the effects of 3 different dose levels of XXX on intravaginal ejaculatory latency time (IELT), patient-reported outcomes, and safety in men with lifelong premature ejaculation (PE). ”

“ A phase 2, multicenter, randomized, double-blind, placebo- and active-controlled trial of XXX (1 - 3 mg/day) as monotherapy or as combination therapy in the treatment of adults with post-traumatic stress disorder. ”

“ A phase 3 randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of XXX as adjunctive therapy for the treatment of Schizophrenia. ”

“ A phase 2 randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of XXX as adjunctive therapy for the treatment of negative symptoms of Schizophrenia. ”

“ A randomized, double-blind, placebo-controlled, multi-center study of XXX as adjunctive therapy in Major Depressive Disorder. ”

“ A randomized, double-blind, placebo-controlled, multi-center study of XXX as adjunctive therapy in the prevention of relapse in patients with Major Depressive Disorder. ”

“ An open-label, long-term safety study of XXX as adjunctive therapy in patients with Major Depressive Disorder. ”

“ Interventional, randomized, double-blind, placebo-controlled, active reference, fixed dose study of XXX in pediatric patients age 7-11 with Major Depressive Disorder. March 2016”

“ Interventional, randomized, double-blind, placebo-controlled, active reference, fixed dose study of XXX in pediatric patients age 12-17 with Major Depressive Disorder. ”

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

“ 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. ”

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

“ An Open-Label Long-term Safety Study of XXX in Pediatric Patients with Major Depressive Disorder. ”

“ 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 pro-cognitive treatment in Schizophrenia subjects on chronic stable atypical antipsychotic therapy. ”

“ A phase IV, randomized, double-blind, active and placebo-controlled, multicenter study evaluating the neuropsychiatric safety and efficacy of 12 weeks of XXX and XXX for smoking cessation in subjects with and without a history of psychiatric disorders. ”

“ A phase IV, non-treatment follow-up for cardiac assessments following use of smoking cessation treatments in subjects with and without a history of psychiatric disorders. ”

“ A randomized, double-blind, placebo-controlled, dose-ranging, parallel-group, phase 2 study of the safety and efficacy of XXX in the treatment of cognitive deficits in Schizophrenia in nonsmokers. ”

“ A long term safety and efficacy of XXX in subjects with Schizophrenia: A double-blind extension study for subjects completing above trial. ”

“ A double-blind, placebo-controlled evaluation of the safety and efficacy of XXX in adolescent patients with major depressive disorder. ”

“ 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 multicenter, open-label study to access hospitalization rates in adult subjects with Schizophrenia treated prospectively for 6 months with XXX IM depot compared with 6 month retrospective treatment with oral antipsychotics in a naturalistic community setting. ”

“ 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 Randomized 6 Week, Double-Blind, Placebo Controlled, Flexible-Dose, Parallel-Group Study of XXX Adjunctive to XXX for the treatment of Bipolar I Depression in Subjects Demonstrating non-response to treatment with XXX alone. ”