Dose Finding Study in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)(174007/P05805/MK-8777-003)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00610441
First received: January 28, 2008
Last updated: August 28, 2014
Last verified: August 2014
Results First Received: May 30, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Attention Deficit Hyperactivity Disorder
Interventions: Drug: MK-8777
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
MK-8777 FD→PBO Participants receive a fixed dose (FD) of MK-8777 100 mg BID for 3 weeks (Treatment Period 1). After a 2-week placebo washout period, participants receive a fixed dose of placebo BID for 3 weeks (Treatment Period 2).
PBO→MK-8777 FD Participants receive a fixed dose of placebo BID for 3 weeks (Treatment Period 1). After a 2-week placebo washout period, participants receive a fixed dose of MK-8777 100 mg BID for 3 weeks (Treatment Period 2).
MK-8777 RD→PBO Participants receive rising doses (RD) of MK-8777 100-300 mg BID for 3 weeks (Treatment Period 1). After a 2-week placebo washout period, participants receive rising doses of placebo BID for 3 weeks (Treatment Period 2).
PBO→MK-8777 RD Participants receive rising doses of placebo BID for 3 weeks (Treatment Period 1). After a 2-week placebo washout period, participants receive rising doses of MK-8777 100-300 mg BID for 3 weeks (Treatment Period 2).

Participant Flow for 3 periods

Period 1:   Treatment Period 1 - 3 Weeks
    MK-8777 FD→PBO     PBO→MK-8777 FD     MK-8777 RD→PBO     PBO→MK-8777 RD  
STARTED     15     16     18     18  
COMPLETED     12     14     11     16  
NOT COMPLETED     3     2     7     2  
Adverse Event                 1                 1                 4                 1  
Lack of Efficacy                 0                 0                 1                 0  
Lost to Follow-up                 1                 1                 1                 0  
Withdrawal by Subject                 1                 0                 1                 1  

Period 2:   Placebo Washout Period - 2 Weeks
    MK-8777 FD→PBO     PBO→MK-8777 FD     MK-8777 RD→PBO     PBO→MK-8777 RD  
STARTED     12     14     11     16  
COMPLETED     12     13     9     16  
NOT COMPLETED     0     1     2     0  
Adverse Event                 0                 0                 2                 0  
Withdrawal by Subject                 0                 1                 0                 0  

Period 3:   Treatment Period 2 - 3 Weeks
    MK-8777 FD→PBO     PBO→MK-8777 FD     MK-8777 RD→PBO     PBO→MK-8777 RD  
STARTED     12     13     9     16  
COMPLETED     10     12     9     14  
NOT COMPLETED     2     1     0     2  
Unspecified                 1                 1                 0                 1  
Adverse Event                 0                 0                 0                 1  
Lack of Efficacy                 1                 0                 0                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
MK-8777 FD→PBO Participants receive a fixed dose FD of MK-8777 100 mg BID for 3 weeks (Treatment Period 1). After a 2-week placebo washout period, participants receive a fixed dose of placebo BID for 3 weeks (Treatment Period 2).
PBO→MK-8777 FD Participants receive a fixed dose of placebo BID for 3 weeks (Treatment Period 1). After a 2-week placebo washout period, participants receive a fixed dose of MK-8777 100 mg BID for 3 weeks (Treatment Period 2).
MK-8777 RD→PBO Participants receive rising doses of MK-8777 100-300 mg BID for 3 weeks (Treatment Period 1). After a 2-week placebo washout period, participants receive rising doses of placebo BID for 3 weeks (Treatment Period 2).
PBO→MK-8777 RD Participants receive rising doses of placebo BID for 3 weeks (Treatment Period 1). After a 2-week placebo washout period, participants receive rising doses of MK-8777 100-300 mg BID for 3 weeks (Treatment Period 2).
Total Total of all reporting groups

Baseline Measures
    MK-8777 FD→PBO     PBO→MK-8777 FD     MK-8777 RD→PBO     PBO→MK-8777 RD     Total  
Number of Participants  
[units: participants]
  15     16     18     18     67  
Age  
[units: years]
Mean ± Standard Deviation
  34.9  ± 8.7     35.1  ± 9.2     36.7  ± 8.8     40.7  ± 6.3     37.0  ± 8.4  
Gender  
[units: participants]
         
Female     3     5     9     5     22  
Male     12     11     9     13     45  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) Score   [ Time Frame: Baseline (BL) and Day 7, Day 14, Day 21 ]

2.  Secondary:   Percentage of Participants With at Least a 30% Reduction From Baseline in AISRS Score   [ Time Frame: Baseline and Day 21 ]

3.  Secondary:   Percentage of Participants With at Least a 50% Reduction From Baseline in AISRS Score   [ Time Frame: Baseline and Day 21 ]

4.  Secondary:   Percentage of Participants Who Experience At Least One Adverse Event (AE)   [ Time Frame: Up to 7 days after last dose of study drug (Up to 63 days) ]

5.  Secondary:   Percentage of Participants Who Discontinue Study Drug Due to an AE   [ Time Frame: Up to last dose of study drug (Up to 56 days) ]

6.  Secondary:   Percentage of Participants With Clinician Global Impression Scale - Severity (CGI-S) Category Scores   [ Time Frame: Days 14-21 ]

7.  Secondary:   Percentage of Participants With Clinician Global Impression Scale - Improvement (CGI-I) Scores   [ Time Frame: Days 14-21 ]

8.  Secondary:   Change From Baseline in Epworth Sleepiness Scale (ESS) Score   [ Time Frame: Baseline and Day 7, Day 14, Day 21 ]

9.  Secondary:   Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Score   [ Time Frame: Baseline and Day 7, Day 14, Day 21 ]

10.  Secondary:   Change From Baseline in Quick Inventory of Depression Symptomology - Clinician Rating (QIDS-C) Score   [ Time Frame: Baseline and Day 7, Day 14, Day 21 ]

11.  Secondary:   Change From Baseline in Time-Sensitive ADHD Symptom Scale (TASS) Score   [ Time Frame: Baseline and Day 7, Day 14, Day 21 ]

12.  Secondary:   Computerized Cognition Assessment: Cognitive Flexibility   [ Time Frame: Day 21 ]

13.  Secondary:   Computerized Cognition Assessment: Complex Attention   [ Time Frame: Day 21 ]

14.  Secondary:   Computerized Cognition Assessment: Composite Memory   [ Time Frame: Day 21 ]

15.  Secondary:   Computerized Cognition Assessment: Executive Functioning   [ Time Frame: Day 21 ]

16.  Secondary:   Computerized Cognition Assessment: Speed of Processing   [ Time Frame: Day 21 ]

17.  Secondary:   Computerized Cognition Assessment: Reaction Time   [ Time Frame: Day 21 ]

18.  Secondary:   Computerized Cognition Assessment: Reasoning   [ Time Frame: Day 21 ]

19.  Secondary:   Computerized Cognition Assessment: Sustained Attention   [ Time Frame: Day 21 ]

20.  Secondary:   Computerized Cognition Assessment: Verbal Memory   [ Time Frame: Day 21 ]

21.  Secondary:   Computerized Cognition Assessment: Visual Memory   [ Time Frame: Day 21 ]

22.  Secondary:   Computerized Cognition Assessment: Working Memory   [ Time Frame: Day 21 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00610441     History of Changes
Other Study ID Numbers: P05805, 174007
Study First Received: January 28, 2008
Results First Received: May 30, 2014
Last Updated: August 28, 2014
Health Authority: United States: Food and Drug Administration