The safety and efficacy of multiple dosages of TD-9855, administered once daily, will be
evaluated in adult males with ADHD.
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Locations near you
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Full eligibility criteria for NCT01458340
Ages eligible for Study
18 Years to 45 Years
Genders eligible for Study
Accepts Healthy Volunteers
Subjects must meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for current ADHD subtypes (ADHD combined type, ADHD predominately inattentive type, ADHD predominately hyperactive-impulsive type) as assessed by the clinical interview and confirmed by Adult Attention-Deficit/Hyperactivity Disorder Clinical Diagnostic Scale (ACDS V1.2).
Subjects must have a total score of 24 or greater on the AISRS at both the Screening and Baseline Visits AND the Baseline Visit AISRS scores must not vary by more than 20% from Screening.
Subjects are required to have CGI-S score ≥4 (moderate) at both the Screening and Baseline Visits. Subjects should have at least moderate severity for ADHD symptoms.
For women of childbearing potential, documentation of a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day 0. All female subjects of childbearing potential must be using a highly effective method of birth control during the study and for at least 1 month after completion of study drug dosing.
A highly effective method of birth control is defined as one that results in a low failure rate (i.e., <1% per year) when used consistently and correctly, such as condom
+ diaphragm, condom + spermicide, diaphragm + spermicide, or intrauterine device [IUD] with documented failure rate of <1% per year, or oral/injectable/implanted hormonal contraceptives used in combination with a barrier method.
Women are considered to be not of childbearing potential if they have had a total hysterectomy or bilateral tubal ligation (documentation for either must be provided before enrollment) or are at least 2 years postmenopausal. Female subjects cannot be breast-feeding.
Any current psychiatric disorder other than ADHD as defined in DSM-IV-TR as assessed by Mini International Neuropsychiatric Interview (MINI). Subjects with dysthymia that does not require pharmacological treatment will not be excluded.
MADRS total score >15.
A diagnosis of ADHD NOS.
Any diagnosis of lifetime bipolar disorder or psychotic disorder
A current diagnosis of any severe comorbid Axis II disorder
Any history of mental retardation, organic mental disorders due to general medical condition or pervasive developmental disorder as defined by DSM-IV-TR.-
All locations for NCT01458340
United States (17)
Florida Clinical Research Center, LLC
Bradenton, Florida, United States, 34201
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, United States, 32256
Florida Clinical Research Center
Maitland, Florida, United States, 34201
Janus Ctr. for Psychiatric Research
Palm Beach, Florida, United States, 33407
Smyrna, Georgia, United States, 30080
Overland Park, Kansas, United States, 66211
Midwest Research Group
Saint Charles, Missouri, United States, 63304
Ctr. for Psychiatry & Behavioral Med.
Las Vegas, Nevada, United States, 89128
Adult ADHD Program
New York, New York, United States, 10016
Oklahoma City, Oklahoma, United States, 73103
Summit Research Network
Portland, Oregon, United States, 97210
Lincoln, Rhode Island, United States, 02865
CNS Healthcare of Memphis
Memphis, Tennessee, United States, 38119
FutureSearch Clinical Trials
Austin, Texas, United States, 78731
Psychiatric & Behavioral Solutions
Salt Lake City, Utah, United States, 84105
Lifetree Clinical Research, LC
Salt Lake City, Utah, United States, 84106
Summit Research Network (Seattle), LLC
Seattle, Washington, United States, 98104
View full eligibility
Tris trial is registered with FDA with number: NCT01458340. The sponsor of the trial is Theravance Biopharma and it is looking for 285 volunteers for the current phase.
Official trial title: A Phase 2 Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Proof-of-Concept Study of TD-9855 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
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