A Study of TD-9855 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)



Status:Completed
Conditions:Neurology, Psychiatric, ADHD
Therapuetic Areas:Neurology, Psychiatry / Psychology, Other
Healthy:No
Age Range:18 - 45
Updated:9/15/2018
Start Date:December 2011
End Date:November 2013

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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)

The safety and efficacy of multiple dosages of TD-9855, administered once daily, will be
evaluated in adult males with ADHD.


Inclusion Criteria:

- Subjects must meet the following ADHD diagnostic and inclusion criteria:

- 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.

Exclusion Criteria:

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.-
We found this trial at
17
sites
Oklahoma City, Oklahoma 73103
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901 Boren Avenue
Seattle, Washington 98104
206-624-4587
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Seattle, WA
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Austin, Texas 78756
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Austin, TX
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8043 Cooper Creek Boulevard Suite 107
Bradenton, Florida 34201
(941) 747-7900
Florida Clinical Research Center, LLC Led by Andrew J. Cutler, M.D., Florida Clinical Research Center,...
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Bradenton, FL
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Jacksonville, Florida 32216
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Jacksonville, FL
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Las Vegas, Nevada 89128
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Las Vegas, NV
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Lincoln, Rhode Island 02865
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Lincoln, RI
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Maitland, Florida 32751
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Maitland, FL
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Memphis, Tennessee 38119
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Memphis, TN
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New York, New York 10016
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New York, NY
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Overland Park, Kansas 66211
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Overland Park, KS
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Palm Beach, Florida 33407
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Palm Beach, FL
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Portland, Oregon 97210
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Portland, OR
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4801 Weldon Spring Parkway
Saint Charles, Missouri 63304
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Saint Charles, MO
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Salt Lake City, Utah 84106
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Salt Lake City, UT
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Salt Lake City, Utah 84105
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Salt Lake City, UT
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Smyrna, Georgia 30080
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Smyrna, GA
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