Trial to Determine the Maximum Tolerated Dose (MTD) Based on Safety and Tolerability, of Org 26576 in Participants With Major Depressive Disorder (174001/P05704/MK-8777-001)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00610649
First received: January 28, 2008
Last updated: June 30, 2014
Last verified: June 2014
Results First Received: May 27, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Depression
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
Part 1: Block A MK-8777 Participants receive MK-8777 initiated at 100 mg twice daily (BID) and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 16 days.
Part 1: Block A Placebo Participants receive placebo BID for a total of 16 days.
Part 1: Block B MK-8777 Participants receive MK-8777 initiated at 200 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 13 days.
Part 1: Block B Placebo Participants receive placebo BID for a total of 13 days.
Part 1: Block C MK-8777 Participants receive MK-8777 initiated at 300 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 10 days.
Part 1: Block C Placebo Participants receive placebo BID for a total of 10 days.
Part 1: Block D MK-8777 Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum dose determined by the results of Block A. Participants receive MK-8777 for a total of 13 days.
Part 1: Block D Placebo Participants receive placebo BID for a total of 13 days.
Part 2: MK-8777 200 mg Participants receive MK-8777 100 mg BID for 27 days followed by one day of 100 mg once daily (QD). Participants receive MK-8777 for a total of 28 days.
Part 2: MK-8777 800 mg Participants receive MK-8777 200 mg BID for 3 days followed by 400 mg BID for 24 days followed by one day of 400 mg QD. Participants receive MK-8777 for a total of 28 days.
Part 2: Placebo Participants receive placebo BID for 27 days followed by one day of placebo QD. Participants receive placebo for 28 days.

Participant Flow:   Overall Study
    Part 1: Block A MK-8777     Part 1: Block A Placebo     Part 1: Block B MK-8777     Part 1: Block B Placebo     Part 1: Block C MK-8777     Part 1: Block C Placebo     Part 1: Block D MK-8777     Part 1: Block D Placebo     Part 2: MK-8777 200 mg     Part 2: MK-8777 800 mg     Part 2: Placebo  
STARTED     4     2     4     2     4     2     4     2     10     10     10  
COMPLETED     3     1     4     2     4     2     4     2     10     9     9  
NOT COMPLETED     1     1     0     0     0     0     0     0     0     1     1  
Adverse Event                 1                 0                 0                 0                 0                 0                 0                 0                 0                 0                 1  
Family Emergency                 0                 1                 0                 0                 0                 0                 0                 0                 0                 0                 0  
Withdrawal by Subject                 0                 0                 0                 0                 0                 0                 0                 0                 0                 1                 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
Part 1: Block A MK-8777 Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 16 days.
Part 1: Block A Placebo Participants receive placebo BID for a total of 16 days.
Part 1: Block B MK-8777 Participants receive MK-8777 initiated at 200 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 13 days.
Part 1: Block B Placebo Participants receive placebo BID for a total of 13 days.
Part 1: Block C MK-8777 Participants receive MK-8777 initiated at 300 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 10 days.
Part 1: Block C Placebo Participants receive placebo BID for a total of 10 days.
Part 1: Block D MK-8777 Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum dose determined by the results of Block A. Participants receive MK-8777 for a total of 13 days.
Part 1: Block D Placebo Participants receive placebo BID for a total of 13 days.
Part 2: MK-8777 200 mg Participants receive MK-8777 100 mg BID for 27 days followed by one day of 100 mg QD. Participants receive MK-8777 for a total of 28 days.
Part 2: MK-8777 800 mg Participants receive MK-8777 200 mg BID for 3 days followed by 400 mg BID for 24 days followed by one day of 400 mg QD. Participants receive MK-8777 for a total of 28 days.
Part 2: Placebo Participants receive placebo BID for 27 days followed by one day of placebo QD. Participants receive placebo for 28 days.
Total Total of all reporting groups

Baseline Measures
    Part 1: Block A MK-8777     Part 1: Block A Placebo     Part 1: Block B MK-8777     Part 1: Block B Placebo     Part 1: Block C MK-8777     Part 1: Block C Placebo     Part 1: Block D MK-8777     Part 1: Block D Placebo     Part 2: MK-8777 200 mg     Part 2: MK-8777 800 mg     Part 2: Placebo     Total  
Number of Participants  
[units: participants]
  4     2     4     2     4     2     4     2     10     10     10     54  
Age  
[units: years]
Mean ± Standard Deviation
  28.8  ± 5.0     32.5  ± 13.4     42.0  ± 14.8     28.5  ± 9.2     35.5  ± 9.7     39.0  ± 14.1     40.5  ± 6.8     36.5  ± 23.3     38.3  ± 14.4     35.6  ± 12.8     31.1  ± 6.5     35.4  ± 11.3  
Gender  
[units: participants]
                       
Female     0     0     4     1     2     0     0     0     4     4     5     20  
Male     4     2     0     1     2     2     4     2     6     6     5     34  



  Outcome Measures
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1.  Primary:   Part 1: Number of Participants With Moderate Intensity Adverse Events (AEs)   [ Time Frame: Up to 7 days following the last dose of study drug (Up to 23 days) ]

2.  Primary:   Part 1: Number of Participants With Serious Adverse Events (SAEs)   [ Time Frame: Up to 30 days following the last dose of study drug (Up to 46 days) ]

3.  Primary:   Part 1: Number of Participants With AEs Leading to Discontinuation of Study Drug   [ Time Frame: Up to the last dose of study drug (Up to 16 days) ]

4.  Primary:   Part 2: Number of Participants With AEs   [ Time Frame: Up to 7 days following the last dose of study drug (Up to 35 days) ]

5.  Primary:   Part 2: Number of Participants With AEs Leading to Discontinuation of Study Drug   [ Time Frame: Up to the last dose of study drug (Up to 28 days) ]

6.  Secondary:   Part 1: Change From Baseline in the Montgomery-Ashberg Depression Rating Scale (MADRS)   [ Time Frame: Baseline and end of treatment (Up to Day 16) ]

7.  Secondary:   Part 2: Change From Baseline in the MADRS   [ Time Frame: Baseline and end of treatment (Up to Day 28) ]


  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 by Merck Sharp & Dohme Corp.

Publications automatically indexed to this study:

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00610649     History of Changes
Other Study ID Numbers: P05704, 174001
Study First Received: January 28, 2008
Results First Received: May 27, 2014
Last Updated: June 30, 2014
Health Authority: United States: Food and Drug Administration