A Study of Infliximab for Treatment Resistant Major Depression

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Andrew H Miller, Emory University
ClinicalTrials.gov Identifier:
NCT00463580
First received: April 19, 2007
Last updated: April 14, 2014
Last verified: February 2014
Results First Received: August 13, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Depression
Interventions: Drug: infliximab (remicade)
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
No text entered.

Reporting Groups
  Description
Infliximab Participants in this arm receive Infliximab(5mg/kg)at Baseline and at weeks 2 and 6 of a 12-week trial.
Placebo Participants in this arm receive normal saline at Baseline and at weeks 2 and 6 of a 12- week trial.

Participant Flow:   Overall Study
    Infliximab     Placebo  
STARTED     30     30  
COMPLETED     27     28  
NOT COMPLETED     3     2  
Lost to Follow-up                 1                 0  
schedule conflict                 2                 0  
Medical/psychiatric complications                 0                 2  



  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
Infliximab Infliximab
Placebo No text entered.
Total Total of all reporting groups

Baseline Measures
    Infliximab     Placebo     Total  
Number of Participants  
[units: participants]
  30     30     60  
Age  
[units: years]
Mean ± Standard Deviation
  42.5  ± 8.2     44.3  ± 9.4     43.4  ± 8.8  
Gender  
[units: participants]
     
Female     20     20     40  
Male     10     10     20  
Region of Enrollment  
[units: participants]
     
United States     30     30     60  
Hamilton Depression Rating Scale-17 item (HDRS-17) [1]
[units: scores on a scale]
Mean ± Standard Deviation
  24.1  ± 4.0     23.6  ± 3.8     23.8  ± 3.9  
[1] Hamilton Depression Rating Scale-17 item; Minimum score= 0 Maximum score= 54; Higher scores represent greater symptom severity



  Outcome Measures
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1.  Primary:   (Study Endpoint): Mean (SD) Hamilton Depression Rating Scale 17-item (HAM-D-17) Scores at Baseline and Each Post Baseline Time Point.   [ Time Frame: baseline and treatment weeks 1, 2, 4, 6, 8, 10 and 12 ]
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Measure Type Primary
Measure Title (Study Endpoint): Mean (SD) Hamilton Depression Rating Scale 17-item (HAM-D-17) Scores at Baseline and Each Post Baseline Time Point.
Measure Description Hamilton Depression Rating Scale-17 item; Minimum score= 0 Maximum score= 54; Higher scores represent greater symptom severity
Time Frame baseline and treatment weeks 1, 2, 4, 6, 8, 10 and 12  
Safety Issue No  

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.
Power calculations were based on standard deviations derived from published literature of HAM-D scores in patients with TRD (60 participants,80% power). An intent-to-treat analysis using mixed-effects model for repeated measures was used to analyze change from baseline of HAM-D scores as a function of treatment, time, and their interaction.

Reporting Groups
  Description
Infliximab Infliximab
Placebo Normal Saline

Measured Values
    Infliximab     Placebo  
Number of Participants Analyzed  
[units: participants]
  30     30  
(Study Endpoint): Mean (SD) Hamilton Depression Rating Scale 17-item (HAM-D-17) Scores at Baseline and Each Post Baseline Time Point.  
[units: scores on a scale]
Mean ± Standard Deviation
   
Baseline     24.1  ± 4.0     23.6  ± 3.8  
Week 1     20.8  ± 6.7     20.4  ± 4.9  
Week 2     18.8  ± 7.0     18.3  ± 6.2  
Week 4     18.8  ± 6.7     16.3  ± 5.7  
Week 6     17.9  ± 6.2     16.4  ± 5.9  
Week 8     17.5  ± 7.4     14.8  ± 6.8  
Week 10     17.4  ± 8.4     13.6  ± 8.3  
Week 12     16.6  ± 8.4     14.0  ± 8.1  

No statistical analysis provided for (Study Endpoint): Mean (SD) Hamilton Depression Rating Scale 17-item (HAM-D-17) Scores at Baseline and Each Post Baseline Time Point.



2.  Secondary:   Number of Patients With a 50% Reduction in HDRS Scores at Any Study Point   [ Time Frame: At any study point ]

3.  Secondary:   Between Group Difference in Percentage of Remitted Patients During Treatment (HDRS ≤7 or CGI of 1)   [ Time Frame: At any study point ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Between Group Differences in Self-reported Depression Scores Measured by the IDS—SR   [ Time Frame: At any study point ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   The Correlation Coefficient Between Changes in HDRS Symptom Score(Measured Numerically and as the Ratio of Change Score to Baseline Score) and Changes in the Plasma Concentrations of TNF-alpha, IL-6 and CRP.   [ Time Frame: Between baseline and any study point ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Between-group Differences (Mean ±SD) in the Change of Cortisol and ACTH Slope, p.m. Cortisol, Diurnal Plasma Cytokine and Cytokine Receptor Concentrations and Sleep Efficiency Between Baseline and Study Week 8.   [ Time Frame: Between baseline and study week 8. ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Correlation Coefficients Between Changes in HDRS Symptom Score and Changes in Diurnal Slope of Cortisol and ACTH, p.m. Cortisol Plasma Concentrations, Diurnal Plasma Concentrations of Inflammatory Cytokines and Their Receptors and Sleep Efficiency   [ Time Frame: Measured numerically and as the ratio of change score to baseline score ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

8.  Secondary:   CRP, IL-6, TNF-alpha, TNFR 1 and 2   [ Time Frame: Baseline ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  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
Our study was underpowered to adequately test placebo response typically reported for TRD. Also, no direct measures of the effect of either infliximab or placebo on the CNS were obtained.


  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: Andrew H. Miller
Organization: Emory University
phone: 404-727-8260
e-mail: amill02@emory.edu


No publications provided by Emory University

Publications automatically indexed to this study:

Responsible Party: Andrew H Miller, Emory University
ClinicalTrials.gov Identifier: NCT00463580     History of Changes
Other Study ID Numbers: IRB00011734, 1R21MH077172-01A2
Study First Received: April 19, 2007
Results First Received: August 13, 2013
Last Updated: April 14, 2014
Health Authority: United States: Institutional Review Board