Dose Finding Study in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)(174007/P05805/MK-8777-003)
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: MK-8777; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 67.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: randomized; double blind; placebo controlled

Summary:

      This is a Phase 2 multicenter, randomized, double-blind trial of MK-8777 (Org 26576, SCH
      900777) in adult subjects with Attention-Deficit/Hyperactivity Disorder (ADHD). MK-8777 or
      placebo will be administered in a crossover fashion for two 3-week treatment periods. The two
      3-week treatment periods will be separated by a 2-week placebo washout period.

      The primary objective is to compare the efficacy of various doses of MK-8777 to that of
      placebo in the treatment of ADHD symptoms in adults.
    

Eligibility criteria:

        Inclusion Criteria:

          -  are between 18-50 years, inclusive;

          -  are male; or female who are non-pregnant, non-lactating and using an acceptable method
             of birth control (intrauterine device, double-barrier method, hormonal
             contraceptives); or female of non-childbearing potential if they are a) surgically
             sterile (tubal ligation, hysterectomy and/or bilateral oophorectomy) and provide
             documentation of the procedure by operative report or ultrasound scan, or b)
             post-menopausal for greater than one year with follicle stimulating hormone (FSH)
             level greater than or equal to 40 mIU/mL at screening. All females must have a
             negative serum pregnancy test at screening;

          -  are outpatients;

          -  provide written informed consent

          -  are fluent in the language of the investigator,

          -  are able to discontinue the use of any psychotropic medications for the treatment of
             ADHD symptoms at screening;

          -  meet strict operational criteria for adult ADHD according to the Diagnostic and
             Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV-TRTM)

          -  have a Clinical Global Impression ADHD score of 4 or higher at screening

        Exclusion Criteria:

          -  have any clinically significant concurrent medical condition (endocrine, renal,
             respiratory, cardiovascular, hematological, immunological, cerebrovascular,
             neurological, anorexia, obesity or malignancy) that has become unstable and may
             interfere with the interpretation of safety and efficacy evaluations.

          -  have any clinically significant abnormal laboratory, vital sign, physical examination,
             or electrocardiogram (ECG) findings at screening that, in the opinion of the
             investigator, may interfere with the interpretation of safety or efficacy evaluations.

          -  have any history of liver disease (e.g., cirrhosis, hepatitis), or liver
             injury;(history of hepatitis A greater than one year prior to screening is
             acceptable); any abnormal clinically significant findings at screening on liver
             laboratory parameters (serum glutamic-pyruvic transaminase [SGPT], serum glutamic
             oxaloacetic transaminase [SGOT], gamma-glutamyltransferase [GGT], lactate
             dehydrogenase [LDH], bilirubin, albumin, protein, alkaline phosphatase);

          -  have a seizure disorder beyond childhood or are taking any anticonvulsants to prevent
             seizures;

          -  have known serological evidence of human immunodeficiency virus (HIV) antibody;

          -  have a positive test result at screening on hepatitis B surface antigen or hepatitis A
             immunoglobulin M (IgM) antibodies or hepatitis C total antibodies;

          -  are pregnant as confirmed by a positive serum pregnancy test at screening;

          -  have QTc values >450 msec at screening using Fridericia's QTc formula;

          -  have a confirmed positive result in the alcohol/drug screen test for alcohol, illegal
             or non-prescribed drugs at screening (except marijuana/ tetrahydrocannabinol [THC]);

          -  have a confirmed positive result in the alcohol/drug screen re-test for marijuana/THC;

          -  have current or lifetime history of bipolar and psychotic disorders;

          -  have a current major depression disorder, obsessive-compulsive disorder,
             post-traumatic stress disorder, generalized anxiety disorder, panic disorder and
             eating disorder (also if treated but not currently symptomatic);

          -  have a current comorbid dysthymia or social anxiety disorder that is currently treated
             with psychotropic medication;

          -  have a current untreated social anxiety disorder that may interfere with the
             assessment of ADHD in the investigator's opinion;

          -  present an imminent risk of self-harm or harm to others;

          -  have any history of a significant suicide attempt, or possess a current risk of
             attempting suicide, in the investigator's opinion, based on clinical interview and
             responses provided on the Beck Scale for Suicidal Ideation (BSS);

          -  have a history of jailing or imprisonment in the past 6 months due to worsening of
             symptoms of ADHD;