Clinical trial NCT00475735: A Study to Test the Safety and Efficacy of MK0249 in Patients With ADHD (0249-018)(COMPLETED)
Official title: A Phase IIa, Randomized, Double-Blind, Placebo-Controlled, Incomplete Block, Two-period, Crossover Clinical Trial to Study the Safety and Efficacy of MK0249, 10 mg, for Adult Patients, Ages 18 to 55, With Attention Deficit Hyperactivity Disorder (ADHD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Attention-Deficit/Hyperactivity Disorder (ADHD)
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-05-21
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the safety and efficacy of an investigational treatment for Attention Deficit Hyperactivity Disorder (ADHD) when compared to placebo.


Eligibility criteria: Inclusion Criteria:

* Patient is between 18 and 55 years of age (inclusive)
* Patient is an adult with a current DSM-IV diagnosis of ADHD of inattentive or combined subtype, as assessed via a structured interview using the ACDS and AISRS
* Females of child-bearing potential must use acceptable methods of birth control during the study and for 1 month post-therapy

Exclusion Criteria:

* Patient has a history of a neurological disorder resulting in ongoing impairment
* Patient has a lifetime history of a psychotic disorder, bipolar disorder, or post-traumatic stress disorder
* Patient has evidence of ongoing depression
* Patient is sensitive or allergic to methylphenidate
* Patient has glaucoma
* Patient has a previous history of narrowing or blockage of the GI tract
* Patient has a history of a sleep disorder (e.g., insomnia, sleep apnea, nightmares, or night terrors) within 6 months prior to screening
* Patient has a history of a cardiovascular disorder within 6 months prior to screening
* Patient has moderate or severe persistent asthma
* Patient has a history of substance abuse or dependence not in sustained full remission for at least one year according to DSM-IV
* Patient has taken part in a research study within the past 30 days of signing informed consent

Primary outcomes:
measure: Mean Change From Baseline in the Adult Attention Deficit Hyperactivity Disorder Investigator Symptom Rating Scale (AISRS) Total Score After 4 Weeks of Treatment
timeFrame: after 4 weeks of treatment
Secondary outcomes:
measure: Mean Change From Baseline in the AISRS Inattentive Subscale Score After 4 Weeks of Treatment
timeFrame: after 4 weeks of treatment
measure: >/= 30% AISRS Total Score Responder Rate After 4 Weeks of Treatment;
timeFrame: after 4 weeks of treatment
measure: >/=1-point Improvement in the CGI-S Score
timeFrame: 4 weeks of treatment
measure: Mean Change From Baseline in the AISRS Hyperactive/Impulsive Subscale Score
timeFrame: 4 weeks of treatment
measure: Mean Change From Baseline in the Conners' Adult ADHD Rating Scale - Observer Screening Version (CAARS-O:SV) Total ADHD Symptom Score.
timeFrame: 4 weeks of treatment
measure: Mean Change From Baseline in the Clinical Global Impressions-severity of Illness Scale(CGI-S) Score
timeFrame: 4 weeks of treatment
Other outcomes:
measure: Baseline AISRS
timeFrame: Baseline
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Herring WJ, Wilens TE, Adler LA, Baranak C, Liu K, Snavely DB, Lines CR, Michelson D. Randomized controlled study of the histamine H3 inverse agonist MK-0249 in adult attention-deficit/hyperactivity disorder. J Clin Psychiatry. 2012 Jul;73(7):e891-8. doi: 10.4088/JCP.11m07178.