Phase 2 Completed N=72 Randomized Double-blind Treatment

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

Attention Deficit Hyperactivity Disorder

Source: ClinicalTrials.gov NCT00475735 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2010

Primary outcomePrimary: Mean Change From Baseline in the Adult Attention Deficit Hyperactivity Disorder Investigator Symptom Rating Scale (AISRS) Total Score After 4 Weeks of Treatment — -9.8; -15.3; -7.6 score on scale — p=0.341

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Change From Baseline in the Adult Attention Deficit Hyperactivity Disorder Investigator Symptom Rating Scale (AISRS) Total Score After 4 Weeks of Treatment	-9.8; -15.3; -7.6	0.341
SECONDARY Mean Change From Baseline in the AISRS Inattentive Subscale Score After 4 Weeks of Treatment	—	—
SECONDARY >/= 30% AISRS Total Score Responder Rate After 4 Weeks of Treatment;	—	—
SECONDARY >/=1-point Improvement in the CGI-S Score	—	—
SECONDARY Mean Change From Baseline in the AISRS Hyperactive/Impulsive Subscale Score	—	—
SECONDARY Mean Change From Baseline in the Conners' Adult ADHD Rating Scale - Observer Screening Version (CAARS-O:SV) Total ADHD Symptom Score.	—	—
SECONDARY Mean Change From Baseline in the Clinical Global Impressions-severity of Illness Scale(CGI-S) Score	—	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00475735). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.