A Study to Test the Safety and Efficacy of MK0249 in Patients With ADHD (0249-018)(COMPLETED)

Phase 2

Completed

• Conditions: Attention-Deficit/Hyperactivity Disorder (ADHD)
• Interventions: Drug: MK0249; Drug: Concerta (methylphenidate); Drug: Placebo

• Registration Number: NCT00475735
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2007-05-17
• Study First Submitted QC: 2007-05-17
• Study First Posted: 2007-05-21
• Study Start: 2007-07
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Results First Submitted: 2010-10-13
• Results First Submitted QC: 2010-11-11
• Results First Posted: 2010-12-10
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-21
• Last Update Posted: 2015-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
MK-0249	MK0249	Total time in the study will be \~10 weeks.
Concerta	Concerta (methylphenidate)	Total time in the study will be \~10 weeks.
Placebo	Placebo	Total time in the study will be \~10 weeks.

Primary Outcome Measures

Name	Time	Method
Mean Change From Baseline in the Adult Attention Deficit Hyperactivity Disorder Investigator Symptom Rating Scale (AISRS) Total Score After 4 Weeks of Treatment	after 4 weeks of treatment	The AISRS total score consists of 18 items from the original Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) which were derived based on Diagnostic and Statistical Manual-4 (DSM-IV) criteria for ADHD. The ADHD-RS include 9 items that address symptoms of inattention and 9 items that address symptoms of impulsivity and hyperactivity. Each item is rated from 0 to 3. The AISRS total score can range from 0 to 54. A higher score corresponds to a worse severity of ADHD.

Secondary Outcome Measures

Name	Time	Method
>/= 30% AISRS Total Score Responder Rate After 4 Weeks of Treatment;	after 4 weeks of treatment	The AISRS total score consists of 18 items from the original ADHD-RS which were derived based on DSM-IV criteria for ADHD. The ADHD-RS include 9 items that address symptoms of inattention and 9 items that address symptoms of impulsivity and hyperactivity. Each item is rated from 0 to 3. The AISRS total score can range from 0 to 54. A higher score corresponds to a worse severity of ADHD.; Data not reported due to failure of primary hypothesis and program termination.
Mean Change From Baseline in the AISRS Hyperactive/Impulsive Subscale Score	4 weeks of treatment	The Adult Attention Deficit Hyperactivity Disorder Investigator Symptom Rating Scale (AISRS) hyperactive/impulsive subscale score consists of 9 items from the original Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) which address hyperactivity and impulsivity. Each item is rated from 0 to 3. The AISRS hyperactive/impulsive subscale score can range from 0 to 27. A higher score corresponds to a worse severity of ADHD hyperactivity/impulsivity.; Data not reported due to failure of primary hypothesis and program termination
Mean Change From Baseline in the Conners' Adult ADHD Rating Scale - Observer Screening Version (CAARS-O:SV) Total ADHD Symptom Score.	4 weeks of treatment	Conners' Adult ADHD Rating Scale - Observer Screening version (CAARS-O: SV) evaluates DSM-IV-oriented inattention, impulsivity and hyperactivity as well as measures of self-concept. It is a 30-item scale administered by a trained investigator or rater with "cue" questions. Each item is scored from 0 to 3 with higher scores corresponding to worse symptoms. The total score can range from 0 to 90.; Data not reported due to failure of primary hypothesis and program termination.
>/=1-point Improvement in the CGI-S Score	4 weeks of treatment	The Clinical Global Impression - Severity of Illness Scale (CGI-S) is administered by a trained investigator who rates the severity of a patient's illness at the time of assessment, relative to the investigator's past experience with patients who have an ADHD diagnosis. The scores range from 1 to 7. Higher numbers correspond to more severe illness.; Data not reported due to failure of primary hypothesis and program termination.
Mean Change From Baseline in the Clinical Global Impressions-severity of Illness Scale(CGI-S) Score	4 weeks of treatment	The Clinical Global Impression - Severity of Illness Scale (CGI-S) is administered by a trained investigator who rates the severity of a patient's illness at the time of assessment, relative to the investigator's past experience with patients who have an ADHD diagnosis. The scores range from 1 to 7. Higher numbers correspond to more severe illness.; Data not reported due to failure of primary hypothesis and program termination.
Mean Change From Baseline in the AISRS Inattentive Subscale Score After 4 Weeks of Treatment	after 4 weeks of treatment	The AISRS inattentive subscale score consists of 9 items from the original ADHD-RS which address inattention. Each item is rated from 0 to 3. The AISRS inattentive subscale score can range from 0 to 27. A higher score corresponds to a worse severity of ADHD inattentiveness.; Data not reported due to failure of primary hypothesis and program termination.