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

Merck Sharp & Dohme LLC72 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Attention-Deficit/Hyperactivity Disorder (ADHD)

Interventions

MK0249DRUG

MK-0249, 10 mg per day was taken orally daily. If patients were unable to tolerate 10 mg per day, they were allowed to titrate down to 5 mg per day.

Concerta (methylphenidate)DRUG

Titration of Concerta began with two 18-mg capsules (36 mg) for 3 consecutive days, followed by three 18-mg capsules (54 mg) for another 3 consecutive days, ending with four 18-mg capsules (72 mg) for the remainder of the treatment period. If patients were unable to tolerate 72 mg per day, they were allowed to titrate down to 54 mg per day. Concerta was taken orally once daily.

PlaceboDRUG

For 4 of the 6 treatment sequences, patients had one 4-week treatment period with placebo of MK-0249 (tablets) and placebo of Concerta (capsules). For patients assigned to active treatments of MK-0249 or Concerta, in order to preserve the blind, placebo of the non-active component was provided, ie, if MK was assigned (tablets), then placebo of Concerta (capsules) was also provided. Each patient was to dose with tablets and capsules, either active or placebo. Placebo was taken orally once daily.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Mean Change From Baseline in the Adult Attention Deficit Hyperactivity Disorder Investigator Symptom Rating Scale (AISRS) Total Score 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.

Time frame: after 4 weeks of treatment

Secondary Outcomes

Mean Change From Baseline in the AISRS Inattentive Subscale Score 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.

Time frame: after 4 weeks of treatment

>/= 30% AISRS Total Score Responder Rate 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.

Time frame: after 4 weeks of treatment

>/=1-point Improvement in the CGI-S Score

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.

Data from ClinicalTrials.gov

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