A Dose-Ranging, Cross-over Study of the Safety and Efficacy of ABT-089 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)

Attention-Deficit/Hyperactivity Disorder Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Dose-Ranging Study of the Safety and Efficacy of ABT-089 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00391729
• Other study ID #: M06-855
• 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