Clinical trial NCT00315276 (phase 2, status: completed)
Conditions: attention deficit hyperactivity disorder, adhd
ICD codes: F90.2, F90.8, F90.9, F90.0, F90.1
Drugs: modafinil
SMILES: NC(=O)C[S@@](=O)C(C1=CC=CC=C1)C1=CC=CC=C1
Eligibility 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.