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Completed

NCT Number: NCT00475735

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

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.

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Key information

Conditions

Attention-Deficit/Hyperactivity Disorder (ADHD) Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MK0249

Drug

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.

Other names: CONCERTA®

Placebo

Drug

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.

Primary outcomes

  1. Mean Change From Baseline in the Adult Attention Deficit Hyperactivity Disorder Investigator Symptom Rating Scale (AISRS) Total Score After 4 Weeks of Treatment

    Time frame: 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 outcomes

  1. Mean Change From Baseline in the AISRS Inattentive Subscale Score After 4 Weeks of Treatment

    Time frame: 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.

  2. >/= 30% AISRS Total Score Responder Rate After 4 Weeks of Treatment;

    Time frame: 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.

  3. >/=1-point Improvement in the CGI-S Score

    Time frame: 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.

  4. Mean Change From Baseline in the AISRS Hyperactive/Impulsive Subscale Score

    Time frame: 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

  5. Mean Change From Baseline in the Conners' Adult ADHD Rating Scale - Observer Screening Version (CAARS-O:SV) Total ADHD Symptom Score.

    Time frame: 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.

  6. Mean Change From Baseline in the Clinical Global Impressions-severity of Illness Scale(CGI-S) Score

    Time frame: 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.

Other outcomes

  1. Baseline AISRS

    Time frame: Baseline

    Baseline values for all treatment groups are equal because

    the constrained longitudinal data analysis (cLDA) model was used

    (Liang and Zeger, 2000, Sankhyā: The Indian Journal of Statistics, Series B 62, 134-148).

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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)

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
May 21, 2007
Registry last updated
Jul 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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