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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00391729
Other study ID # M06-855
Secondary ID
Status Completed
Phase Phase 2
First received October 20, 2006
Last updated October 14, 2011
Start date October 2006
Est. completion date June 2007

Study information

Verified date October 2011
Source Abbott
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The objective of this study is to compare the safety and efficacy of five doses of ABT-089 (2 mg QD, 5 mg QD, 15 mg QD, 40 mg QD and 40 mg BID) to placebo in adults with ADHD.


Recruitment information / eligibility

Status Completed
Enrollment 221
Est. completion date June 2007
Est. primary completion date June 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- Meet criteria for attention deficit hyperactivity disorder

- Have voluntarily signed an informed consent form

- Are between 18 and 60 years of age

- Will use contraceptive methods during the study

- Women must not be pregnant or breast-feeding

- Must be in generally good health

- Are fluent in English

Exclusion Criteria:

- They have a current or past diagnosis of schizoaffective disorder, schizophrenia, obsessive-compulsive disorder, drug-induced psychosis, bipolar disorder, psychotic disorder or mental retardation

- They have a current diagnosis of major depressive episode, generalized anxiety disorder (GAD), or post-traumatic stress disorder (PTSD) or have a clinically significant sleep disorder requiring treatment

- They require ongoing treatment or expected treatment with any psychotropic medication, including anxiolytics, antipsychotics, anticonvulsants, antidepressants or mood stabilizers

- They failed to respond to two or more adequate trials of FDA-approved ADHD medication

- They have violent, homicidal or suicidal ideation

- They have a significant history of medical diagnoses, seizure disorder, Tourette's syndrome or a central nervous system (CNS) disease, excluding ADHD

- They have a urine drug screen that is positive for alcohol or drugs of abuse

- They have a history of substance or alcohol disorder (abuse/dependence) during the last 3 months

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms

  • Attention Deficit Disorder with Hyperactivity
  • Attention-Deficit/Hyperactivity Disorder
  • Hyperkinesis

Intervention

Drug:
ABT-089
Subjects will take 2 mg QD, 5 mg QD, 15 mg QD, 40 mg QD, 40 mg BID for 4-6 weeks
Placebo
Subjects will take placebo QD, BID for 4-6 weeks

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Abbott

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Investigator-rated Connors' Adult ADHD Rating Scale(CAARS) total score at the final evaluation of each 4-week treatment period No
Secondary CAARS Inattentive and Hyperactive/Impulsive Sub scales Scores at the final evaluation of each 4-week treatment period No
Secondary CAARS ADHD Index, CAARS:Self at the final evaluation of each 4-week treatment period No
Secondary CGI-ADHD-S, AISRS, TASS, FTND at the final evaluation of each 4-week treatment period No
Secondary QSU-Brief, CANTAB cognitive battery at the final evaluation of each 4-week treatment period No
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