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 |
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.
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
Click here to add this to my saved trials
Click here to add this to my saved trials
8043 Cooper Creek Boulevard
Suite 107
Bradenton, Florida 34201
Bradenton, Florida 34201
(941) 747-7900
Florida Clinical Research Center, LLC Led by Andrew J. Cutler, M.D., Florida Clinical Research Center,...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials