Dose-Finding Study to Evaluate the Efficacy and Safety of Modafinil as Treatment for Adults With ADHD
Information source: Cephalon
Information obtained from ClinicalTrials.gov on March 21, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Attention Deficit Hyperactivity Disorder; ADHD
Intervention: Modafinil (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Cephalon
Summary
The purpose of the study is to evaluate the efficacy and safety of modafinil administered
once daily for 9 weeks at doses of 255, 340, 425, and 510 mg as treatment for adults with
ADHD.
Clinical Details
Official title: A 9-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Finding Study to Evaluate the Efficacy and Safety of Modafinil as Treatment for Adults With Attention Deficit/Hyperactivity Disorder
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Detailed description:
The primary objective of the study is to determine whether modafinil at 255, 340, 425, or 510
mg'day is more effective than a placebo in alleviating the symptoms of
Attention-Deficit/Hyperactivity Disorder (ADHD) in adults as determined by the change from
baseline in the total score from the investigator-completed Adult ADHD Investigator Symptoms
Rating Scale (AISRS) the at endpoint (last post-baseline observation [week 9 or early
termination]).
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Written informed consent is obtained.
- The patient is 18 to 65 years of age (inclusive) at the screening visit and is English
speaking.
- At screening (after washout, if required) the patient meets the full Diagnostic and
Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR)
criteria for ADHD (combined type, predominantly inattentive subtype, or predominantly
hyperactivity-impulsive subtype), for which symptoms were present for the age of 7 and
symptoms have been persistent for at least the last 6 months, according to a
psychiatric/clinical evaluation using the adult ADHD Clinical Diagnosis Scale, Version
1. 2 (ACDS).
- The patient has a Hamilton Anxiety Scale (HAM-A) and a Hamilton Depression Scale
(HAM-D) score less than 15.
- The patient has an AISRS total score of greater than 24 at the screening and baseline
visits, and the difference in the total score from the screening visit to the baseline
visit is less than 25%.
- The patient has a Clinical Global Impression of Severity of Illness (CGI-S) rating for
ADHD of at least 4 at the baseline visit.
- Women of childbearing potential (not surgically sterile or 2 years postmenopausal),
must use a medically accepted method of contraception and must agree to continue use
of this method for the duration of the study and for 30 days after participation in
the study. Acceptable methods of contraception include barrier method with
spermicide, steroidal contraceptive (oral, transdermal, implanted, and injected) in
conjunction with a barrier method, or intrauterine device [IUD].
- The patient must be willing and able to comply with study restrictions and to remain
at the clinic for the required duration during the study period, and willing to return
to the clinic for the follow-up evaluation as specified in this protocol.
Exclusion Criteria:
- The patient has a history or current diagnosis of schizophrenia, bipolar or other
psychotic disorders, or clinical assessment of suicide risk.
- The patient has any current psychiatric comorbidity, including but not limited to
depression or other mood disorder or anxiety disorder, that requires pharmacotherapy.
Comorbidities will be assessed using selected modules (ie, psychosis, substance abuse,
mood disorder, anxiety disorders) of the Structured Clinical Interview for DSM-IV-TR
(SCID).
- The patient has a current diagnosis of a clinically significant sleep disorder.
- The patient is intellectually challenged, as determined by the investigator.
- The patient is satisfied with current ADHD medication and has no unacceptable
medication side effects.
- The patient has previously used modafinil.
- The patient is using other prescription medications for ADHD with psychoactive
properties (eg, amphetamine, dextroamphetamine, methylphenidate, pemoline,
atomoxetine) at the baseline visit.
- The patient has had drug or alcohol abuse or dependence within the last 6 months.
- The patient has used monoamine oxidase (MAO) inhibitors or selective serotonin
reuptake inhibitors (SSRIs) within 2 weeks before the baseline visit.
- The patient has used an investigational drug within 1 month before the baseline
visit.
- The patient is pregnant or lactating. (Any patients becoming pregnant during the
study will be withdrawn from the study).
- The patient has any clinically significant uncontrolled medical conditions (treated or
untreated).
- The patient has a clinically significant deviation from normal in the physical
examination.
- The patient has any disorder that may interfere with drug absorption, distribution,
metabolism, or excretion.
Locations and Contacts
Neurology Clinical Study Centers, LLC, Little Rock, Arkansas 72205, United States
Bay Area Research Institute, Lafayette, California 94549, United States
Pharmacology Research Institute, Northridge, California 91324, United States
UCSD Medical Center, San Diego, California 92103, United States
Peninsula Research Associates, Rolling Hills Estates, California 90274, United States
Clinical Neuroscience Solution, Inc., Orlando, Florida 32806, United States
University of Illinois, Chicago, Illinois 60608, United States
Michael J. Reiser, MD, LLC, Lexington, Kentucky 40509, United States
Adult ADD Center of Maryland, Lutherville, Maryland 21093, United States
Massachusetts General Hospital, Cambridge, Massachusetts 02138, United States
Rochester Center for Behavioral Medicine, Rochester, Michigan 48307, United States
CRI WorldWide, LLC, Clementon, New Jersey 08021, United States
New York University, New York, New York 10010, United States
Summit Research Network Inc., Portland, Oregon 97210, United States
CRI WorldWide, LLC, Philadelphia, Pennsylvania 19149, United States
South East Health Consultants, LLC, Charleston, South Carolina 29407, United States
Clinical Neuroscience Solution, Memphis, Tennessee 38119, United States
Neuropsychiatric Associates, Woodstock, Vermont 05091, United States
Additional Information
Starting date: May 2006
Ending date: January 2007
Last updated: November 9, 2007
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