Status:
COMPLETED
A Study of TD-9855 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
Lead Sponsor:
Theravance Biopharma
Conditions:
Attention-Deficit/Hyperactivity Disorder
ADHD
Eligibility:
All Genders
18-45 years
Phase:
PHASE2
Brief Summary
The safety and efficacy of multiple dosages of TD-9855, administered once daily, will be evaluated in adult males with ADHD.
Eligibility Criteria
Inclusion
- 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
- 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.-
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
295 Patients enrolled
Trial Details
Trial ID
NCT01458340
Start Date
December 1 2011
End Date
November 1 2013
Last Update
April 4 2022
Active Locations (17)
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1
Florida Clinical Research Center, LLC
Bradenton, Florida, United States, 34201
2
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, United States, 32256
3
Florida Clinical Research Center
Maitland, Florida, United States, 34201
4
Janus Ctr. for Psychiatric Research
Palm Beach, Florida, United States, 33407