Anti-INFLammatory to Address Mood and Endothelial Dysfunction (INFLAMED) (INFLAMED)

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
NCT01625845
First received: June 19, 2012
Last updated: October 30, 2015
Last verified: October 2015
Results First Received: May 28, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Major Depressive Disorder
Depression
Depressive Symptoms
Cardiovascular Disease (CVD)
Coronary Artery Disease (CAD)
Heart Disease
Interventions: Drug: Pentoxifylline
Other: Placebo
Behavioral: Standard Treatment

  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
Recruitment was open from June 28, 2012 to February 28, 2014. Participants were recruited from Eskenazi Health and Indiana University Health primary care clinics in Indianapolis. 1369 patients were screened, of whom 36 (2.6%) were eligible and provided informed consent. 16 patients (44%) attended the pre-treatment visit and were randomized.

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
Pentoxifylline + Standard Treatment

Pentoxifylline: Pentoxifylline is phosphodiesterase inhibitor that interferes with proinflammatory cytokine signaling and synthesis. Participants will be instructed to take pentoxifylline 400 mg p.o. t.i.d. for 12 weeks.

Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions.

Placebo + Standard Treatment

Placebos: Placebo pills will match the study drug for color, taste, texture, size, and smell. Participants will receive the same instructions as those randomized to pentoxifylline.

Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions.


Participant Flow:   Overall Study
    Pentoxifylline + Standard Treatment     Placebo + Standard Treatment  
STARTED     10     6  
COMPLETED     5     3  
NOT COMPLETED     5     3  
Adverse Event                 1                 2  
Lost to Follow-up                 2                 1  
Withdrawal by Subject                 2                 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
Pentoxifylline + Standard Treatment

Pentoxifylline: Pentoxifylline is phosphodiesterase inhibitor that interferes with proinflammatory cytokine signaling and synthesis. Participants will be instructed to take pentoxifylline 400 mg p.o. t.i.d. for 12 weeks.

Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions.

Placebo + Standard Treatment

Placebos: Placebo pills will match the study drug for color, taste, texture, size, and smell. Participants will receive the same instructions as those randomized to pentoxifylline.

Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions.

Total Total of all reporting groups

Baseline Measures
    Pentoxifylline + Standard Treatment     Placebo + Standard Treatment     Total  
Number of Participants  
[units: participants]
  10     6     16  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     9     6     15  
>=65 years     1     0     1  
Gender  
[units: participants]
     
Female     5     4     9  
Male     5     2     7  



  Outcome Measures
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1.  Primary:   Change in Brachial Flow-Mediated Dilation (FMD) From Pre- to Post- Treatment   [ Time Frame: 0 and 12 weeks ]

2.  Primary:   Change in Depressive Symptoms Severity (Hopkins Symptom Checklist Depression Scale; SCL-20) From Pre- to Post- Treatment   [ Time Frame: 0 and 12 weeks ]

3.  Secondary:   Change in Circulating Tumor Necrosis Factor-Alpha (TNF-a) From Pre- to Post-Treatment   [ Time Frame: 0 and12 weeks ]

4.  Secondary:   Change in Circulating Interleukin-6 (IL-6) From Pre- to Post-Treatment   [ Time Frame: 0 and 12 weeks ]

5.  Secondary:   Change in Circulating Interleukin-10 (IL-10) From Pre- to Post-Treatment   [ Time Frame: 0 and 12 weeks ]

6.  Secondary:   Change in Interleukin-1ra (IL-1ra) From Pre- to Post-Treatment   [ Time Frame: 0 and 12 weeks ]

7.  Secondary:   Change in Circulating C-Reactive Protein (CRP) From Pre- to Post-Treatment   [ Time Frame: 0 and 12 weeks ]


  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

Missing data precluded analysis of two secondary outcome variables: IL-1α and IL-1β.

Due to the very small sample of randomized patients, conclusions should not be drawn from the results of this pilot trial.



  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Jesse C. Stewart, Ph.D.
Organization: Indiana University-Purdue University Indianapolis (IUPUI)
phone: (317) 274-6761
e-mail: jstew@iupui.edu



Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT01625845     History of Changes
Other Study ID Numbers: 1110007119
R24MH080827 ( US NIH Grant/Contract Award Number )
1737 ( Other Identifier: Indiana Clinical Research Center )
Study First Received: June 19, 2012
Results First Received: May 28, 2015
Last Updated: October 30, 2015
Health Authority: United States: Institutional Review Board
United States: Federal Government