Dose-Finding Study to Evaluate the Efficacy and Safety of Modafinil as Treatment for Adults With ADHD

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT00315276
First received: April 17, 2006
Last updated: August 22, 2012
Last verified: November 2007
  Purpose

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.


Condition Intervention Phase
Attention Deficit Hyperactivity Disorder
ADHD
Drug: Modafinil
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Estimated Enrollment: 370
Study Start Date: May 2006
Study Completion Date: January 2007
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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  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: NCT00315276

Locations
United States, Arkansas
Neurology Clinical Study Centers, LLC
Little Rock, Arkansas, United States, 72205
United States, California
Bay Area Research Institute
Lafayette, California, United States, 94549
Pharmacology Research Institute
Northridge, California, United States, 91324
Peninsula Research Associates
Rolling Hills Estates, California, United States, 90274
UCSD Medical Center
San Diego, California, United States, 92103
United States, Florida
Clinical Neuroscience Solution, Inc.
Orlando, Florida, United States, 32806
United States, Illinois
University of Illinois
Chicago, Illinois, United States, 60608
United States, Kentucky
Michael J. Reiser, MD, LLC
Lexington, Kentucky, United States, 40509
United States, Maryland
Adult ADD Center of Maryland
Lutherville, Maryland, United States, 21093
United States, Massachusetts
Massachusetts General Hospital
Cambridge, Massachusetts, United States, 02138
United States, Michigan
Rochester Center for Behavioral Medicine
Rochester, Michigan, United States, 48307
United States, New Jersey
CRI WorldWide, LLC
Clementon, New Jersey, United States, 08021
United States, New York
New York University
New York, New York, United States, 10010
United States, Oregon
Summit Research Network Inc.
Portland, Oregon, United States, 97210
United States, Pennsylvania
CRI WorldWide, LLC
Philadelphia, Pennsylvania, United States, 19149
United States, South Carolina
South East Health Consultants, LLC
Charleston, South Carolina, United States, 29407
United States, Tennessee
Clinical Neuroscience Solution
Memphis, Tennessee, United States, 38119
United States, Vermont
Neuropsychiatric Associates
Woodstock, Vermont, United States, 05091
Sponsors and Collaborators
Cephalon
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00315276     History of Changes
Other Study ID Numbers: C1538/2027/AD/US
Study First Received: April 17, 2006
Last Updated: August 22, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Teva Pharmaceutical Industries:
ADHD

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
Modafinil
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on July 10, 2014