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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Theravance, Inc.
ClinicalTrials.gov Identifier:
NCT01458340
First received: October 20, 2011
Last updated: November 8, 2013
Last verified: November 2013
  Purpose

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


Condition Intervention Phase
Attention-Deficit/Hyperactivity Disorder
ADHD
Drug: TD-9855
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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)

Resource links provided by NLM:


Further study details as provided by Theravance, Inc.:

Primary Outcome Measures:
  • Adult ADHD Investigator Symptom Rating Scale (AISRS) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    The Adult ADHD Investigator Symptom Rating Scale (AISRS) is a modified version of the ADHD Rating Scale that more accurately reflects the impact and severity of ADHD among adults. It is a clinician-administered scale that measures all 18 symptoms of adult ADHD using a Likert scale (from 0 [not present] to 3 [severe]). The total ranges from 0 to 54.


Secondary Outcome Measures:
  • Barkley Deficits in Executive Functioning Scale-short form: self report (BDEFS-SF:Self-Report) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    The Barkley Deficits in Executive Functioning Scale-short form: self report (BDEFS-SF:Self-Report) is an empirically based tool for evaluating dimensions of adult executive functioning in daily life. The BDEFS-SF offers an ecologically valid snapshot of the capacities involved in time management; organization and problem solving; self restraint; self motivation; and self-regulation of emotions. The total score on the BDEFS-SF range from 0 to 80.


Estimated Enrollment: 285
Study Start Date: December 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dose 1 Drug: TD-9855
Once daily
Experimental: Placebo Drug: Placebo
Once daily
Experimental: Dose 2 Drug: TD-9855
Once daily

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.-
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01458340

Locations
United States, Florida
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
United States, Georgia
Carman Research
Smyrna, Georgia, United States, 30080
United States, Kansas
Psychiatric Associates
Overland Park, Kansas, United States, 66211
United States, Missouri
Midwest Research Group
St. Charles, Missouri, United States, 63304
United States, Nevada
Ctr. for Psychiatry & Behavioral Med.
Los Vegas, Nevada, United States, 89128
United States, New York
Adult ADHD Program
New York, New York, United States, 10016
United States, Oklahoma
IPS Research
Oklahoma City, Oklahoma, United States, 73103
United States, Oregon
Summit Research Network
Portland, Oregon, United States, 97210
United States, Rhode Island
Lincoln Research
Lincoln, Rhode Island, United States, 02865
United States, Tennessee
CNS Healthcare of Memphis
Memphis, Tennessee, United States, 38119
United States, Texas
FutureSearch Clinical Trials
Austin, Texas, United States, 78731
United States, Utah
Lifetree Clinical Research, LC
Salt Lake City, Utah, United States, 84106
Psychiatric & Behavioral Solutions
Salt Lake City, Utah, United States, 84105
United States, Washington
Summit Research Network (Seattle), LLC
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Theravance, Inc.
  More Information

No publications provided

Responsible Party: Theravance, Inc.
ClinicalTrials.gov Identifier: NCT01458340     History of Changes
Other Study ID Numbers: 0085
Study First Received: October 20, 2011
Last Updated: November 8, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Theravance, Inc.:
Adult ADHD
Attention-Deficit/Hyperactivity Disorder

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 22, 2014