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

Completed · Phase 2 · Has a placebo group

Conditions studied: Attention-Deficit/Hyperactivity Disorder, ADHD

In brief

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

Key facts

Study ID

NCT01458340

Run by

Theravance Biopharma

People needed

295

Starts

2011-12-01

Expected to finish

2013-11-01

Last updated by the study team

2022-04-04

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.-

Where it is running

• Florida Clinical Research Center, LLC — Bradenton, Florida, United States
• Clinical Neuroscience Solutions, Inc. — Jacksonville, Florida, United States
• Florida Clinical Research Center — Maitland, Florida, United States
• Janus Ctr. for Psychiatric Research — Palm Beach, Florida, United States
• Carman Research — Smyrna, Georgia, United States
• Psychiatric Associates — Overland Park, Kansas, United States
• Midwest Research Group — Saint Charles, Missouri, United States
• Ctr. for Psychiatry & Behavioral Med. — Las Vegas, Nevada, United States
• Adult ADHD Program — New York, New York, United States
• IPS Research — Oklahoma City, Oklahoma, United States
• Summit Research Network — Portland, Oregon, United States
• Lincoln Research — Lincoln, Rhode Island, United States
• CNS Healthcare of Memphis — Memphis, Tennessee, United States
• FutureSearch Clinical Trials — Austin, Texas, United States
• Psychiatric & Behavioral Solutions — Salt Lake City, Utah, United States
• Lifetree Clinical Research, LC — Salt Lake City, Utah, United States
• Summit Research Network (Seattle), LLC — Seattle, Washington, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.