Antidepressant Effects of NR2B in Major Depression

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Carlos Zarate, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00472576
First received: May 10, 2007
Last updated: July 19, 2012
Last verified: July 2012
Results First Received: March 14, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Major Depression
Interventions: Drug: MK-0657
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
Patients were recruited to participate at the Clinical Center on the campus of the National Institutes of Health in Bethesda, Maryland.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
24 patients were screened, 19 subjects were excluded as they did not meet criteria (total n=13) or refused to participate (n=6).

Reporting Groups
  Description
Placebo Then MK-0657 Patients receive placebo for 12 days, have no treatment for 14 days, then receive 4-8 mg of MK-0657 for 12 days.
MK-0657 Then Placebo Patients receive 4-8 mg of MK-0657 for 12 days, have no treatment for 14 days, then receive placebo for 12 days.

Participant Flow for 2 periods

Period 1:   First Intervention
    Placebo Then MK-0657     MK-0657 Then Placebo  
STARTED     2     3  
COMPLETED     2     3  
NOT COMPLETED     0     0  

Period 2:   Second Intervention
    Placebo Then MK-0657     MK-0657 Then Placebo  
STARTED     2     3  
COMPLETED     2     3  
NOT COMPLETED     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.
No text entered.

Reporting Groups
  Description
Placebo Then MK-0657 Patients receive placebo for 12 days, have no treatment for 14 days, then receive 4-8 mg of MK-0657 for 12 days.
MK-0657 Then Placebo Patients receive 4-8 mg of MK-0657 for 12 days, have no treatment for 14 days, then receive placebo for 12 days.
Total Total of all reporting groups

Baseline Measures
    Placebo Then MK-0657     MK-0657 Then Placebo     Total  
Number of Participants  
[units: participants]
  2     3     5  
Age  
[units: Participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     2     3     5  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  55  ± 0     36  ± 12     43  ± 13  
Gender  
[units: participants]
     
Female     1     1     2  
Male     1     2     3  
Region of Enrollment  
[units: participants]
     
United States     2     3     5  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Montgomery-Asberg Depression Rating Scale (MADRS)   [ Time Frame: Measured daily for 12 days, where the endpoint is the primary outcome ]

2.  Secondary:   Hamilton Depression Rating Scale (HDRS)   [ Time Frame: Measured daily for 12 days, where the endpoint is primary ]


  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
The study was ended early due to recruitment problems.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Dr. Carlos Zarate
Organization: Experimental Therapeutics and Pathophysiology Branch, DIRP, NIMH
phone: 301-451-0861
e-mail: zaratec@mail.nih.gov


Publications:
Publications automatically indexed to this study:

Responsible Party: Carlos Zarate, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00472576     History of Changes
Other Study ID Numbers: 070152, 07-M-0152
Study First Received: May 10, 2007
Results First Received: March 14, 2011
Last Updated: July 19, 2012
Health Authority: United States: Federal Government
United States: Food and Drug Administration