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Antidepressant Effects of NR2B in Major Depression

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ClinicalTrials.gov Identifier: NCT00472576
Recruitment Status : Completed
First Posted : May 11, 2007
Results First Posted : April 7, 2011
Last Update Posted : August 3, 2012
Sponsor:
Information provided by (Responsible Party):
Carlos Zarate, M.D., National Institutes of Health Clinical Center (CC)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Major Depression
Interventions Drug: MK-0657
Drug: Placebo
Enrollment 5
Recruitment Details Patients were recruited to participate at the Clinical Center on the campus of the National Institutes of Health in Bethesda, Maryland.
Pre-assignment Details 24 patients were screened, 19 subjects were excluded as they did not meet criteria (total n=13) or refused to participate (n=6).
Arm/Group Title Placebo Then MK-0657 MK-0657 Then Placebo
Hide Arm/Group Description Patients receive placebo for 12 days, have no treatment for 14 days, then receive 4-8 mg of MK-0657 for 12 days. Patients receive 4-8 mg of MK-0657 for 12 days, have no treatment for 14 days, then receive placebo for 12 days.
Period Title: First Intervention
Started 2 3
Completed 2 3
Not Completed 0 0
Period Title: Second Intervention
Started 2 3
Completed 2 3
Not Completed 0 0
Arm/Group Title Placebo Then MK-0657 MK-0657 Then Placebo Total
Hide Arm/Group Description Patients receive placebo for 12 days, have no treatment for 14 days, then receive 4-8 mg of MK-0657 for 12 days. Patients receive 4-8 mg of MK-0657 for 12 days, have no treatment for 14 days, then receive placebo for 12 days. Total of all reporting groups
Overall Number of Baseline Participants 2 3 5
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 3 participants 5 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
2
 100.0%
3
 100.0%
5
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2 participants 3 participants 5 participants
55  (0) 36  (12) 43  (13)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 3 participants 5 participants
Female
1
  50.0%
1
  33.3%
2
  40.0%
Male
1
  50.0%
2
  66.7%
3
  60.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2 participants 3 participants 5 participants
2 3 5
1.Primary Outcome
Title Montgomery-Asberg Depression Rating Scale (MADRS)
Hide Description The Montgomery-Asberg Depression Rating Scale (MADRS) measures the severity of depression where smaller scores indicate less depression and higher scores suggest more severe depression. Possible scores for this 10 item version range from 0 to 60. Generally, a score of 18 or greater is used to indicate a substantial depression level. The measure at the end of the study is the primary outcome.
Time Frame Measured daily for 12 days, where the endpoint is the primary outcome
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants includes all patients who received at least one rating after taking even a single dose of either active drug or placebo.
Arm/Group Title Placebo MK-0657
Hide Arm/Group Description:
Patients receive 4 to 8 mg of an inactive equivalent of MK-0657 for 12 days.
Patients receive 4 to 8 mg of MK-0657 for 12 days.
Overall Number of Participants Analyzed 5 5
Least Squares Mean (Standard Error)
Unit of Measure: Score on a scale
22.519  (2.091) 23.633  (2.091)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, MK-0657
Comments A linear mixed model with restricted maximum likelihood estimation was used to examine the effects of treatment (MK-0657 and placebo) over time (treatment day) with the baseline of each phase as a covariate. A main effect for phase of study was also included. Schwarz’s Bayesian criteria was used to determine the best fitting variance-covariance structure which was an autoregressive moving average model. Bonferroni adjusted simple effects tests were used to evaluate significant effects.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .272
Comments This test is a comparison of the MK-0657 condition to the placebo condition.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.040
Confidence Interval (2-Sided) 95%
-6.981 to 2.901
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.479
Estimation Comments The primary outcome of interest is whether the groups differ at the end of the study, so the means represent values at that point in time.
2.Secondary Outcome
Title Hamilton Depression Rating Scale (HDRS)
Hide Description The Hamilton Depression Rating Scale (HDRS) measures the severity of depression where smaller scores indicate less depression and higher scores suggest more severe depression. Possible scores for this 17 item version range from 0 to 52. Generally, a score of 18 or greater is used to indicate a substantial depression level. The measure at the end of the study is primary.
Time Frame Measured daily for 12 days, where the endpoint is primary
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants includes all patients who received at least one rating after taking even a single dose of either active drug or placebo.
Arm/Group Title Placebo MK-0657
Hide Arm/Group Description:
Patients receive 4 to 8 mg of an inactive equivalent of MK-0657 for 12 days.
Patients receive 4 to 8 mg of MK-0657 for 12 days.
Overall Number of Participants Analyzed 5 5
Least Squares Mean (Standard Error)
Unit of Measure: Score on a scale
15.671  (1.319) 13.380  (1.319)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, MK-0657
Comments A linear mixed model with restricted maximum likelihood estimation was used to examine the effects of treatment (MK-0657 and placebo) over time (treatment day) with the baseline of each phase as a covariate. A main effect for phase of study was also included. Schwarz’s Bayesian criteria was used to determine the best fitting variance-covariance structure which was an autoregressive moving average model. Bonferroni adjusted simple effects tests were used to evaluate significant effects.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.291
Confidence Interval (2-Sided) 95%
0.911 to 3.671
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.693
Estimation Comments Mean differences reflect groups differences at end point.
Time Frame Data were examined for the full length of the study from pre-study washout through completion of the second intervention, a total of 59 days.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo MK-0657
Hide Arm/Group Description Patients receive 4 to 8 mg of an inactive equivalent of MK-0657 for 12 days. Patients receive 4 to 8 mg of MK-0657 for 12 days.
All-Cause Mortality
Placebo MK-0657
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo MK-0657
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/5 (0.00%)      0/5 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo MK-0657
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/5 (80.00%)      3/5 (60.00%)    
Musculoskeletal and connective tissue disorders     
Muscle, bone, or joint pain   0/5 (0.00%)  0 1/5 (20.00%)  1
Psychiatric disorders     
Tiredness/Fatigue   2/5 (40.00%)  2 1/5 (20.00%)  1
Difficulty falling asleep   2/5 (40.00%)  2 2/5 (40.00%)  2
Interrupted Sleep   3/5 (60.00%)  3 1/5 (20.00%)  1
Early morning awakening   0/5 (0.00%)  0 1/5 (20.00%)  1
Depression   1/5 (20.00%)  1 2/5 (40.00%)  2
Reproductive system and breast disorders     
Decreased Libido   3/5 (60.00%)  3 3/5 (60.00%)  3
Indicates events were collected by systematic assessment
The study was ended early due to recruitment problems.
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
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 ( Other Identifier: National Institutes of Health )
First Submitted: May 10, 2007
First Posted: May 11, 2007
Results First Submitted: March 14, 2011
Results First Posted: April 7, 2011
Last Update Posted: August 3, 2012