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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2

Conditions: Attention-Deficit/Hyperactivity Disorder (ADHD)

Treatments: Drug: Placebo; Drug: Concerta (methylphenidate); Drug: MK0249

Study type: Interventional

Funder types: Industry

Identifiers

NCT00475735

0249-018

2007_519

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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72 participants in 3 patient groups, including a placebo group

MK-0249

Experimental group

Description:

Total time in the study will be \~10 weeks.

Treatment:

Drug: MK0249

Concerta

Active Comparator group

Description:

Total time in the study will be \~10 weeks.

Treatment:

Drug: Concerta (methylphenidate)

Placebo

Placebo Comparator group

Description:

Total time in the study will be \~10 weeks.

Treatment:

Drug: Placebo