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Pilot Study of Open-label Placebo to Treat Major Depressive Disorder

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01103271
First Posted: April 14, 2010
Last Update Posted: January 14, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Harvard University
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Maurizio Fava, MD, Massachusetts General Hospital
Results First Submitted: May 2, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Condition: Major Depressive Disorder
Intervention: Other: Open-label 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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 33 participants were screened for this study.

Reporting Groups
  Description
Immediate Treatment Participants will begin taking placebo pills for four weeks immediately after enrolling in the study.
Waitlist Treatment Participants will wait two weeks after enrolling in the study to begin taking placebo pills for four weeks.

Participant Flow:   Overall Study
    Immediate Treatment   Waitlist Treatment
STARTED   11   9 
COMPLETED   10   5 
NOT COMPLETED   1   4 



  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
Immediate Treatment Participants will begin taking placebo pills for four weeks immediately after enrolling in the study.
Waitlist Treatment Participants will wait two weeks after enrolling in the study to begin taking placebo pills for four weeks.
Total Total of all reporting groups

Baseline Measures
   Immediate Treatment   Waitlist Treatment   Total 
Overall Participants Analyzed 
[Units: Participants]
 11   9   20 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   11   9   20 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 37.2  (12.0)   40.8  (13.7)   38.8  (12.6) 
Gender 
[Units: Participants]
     
Female   8   6   14 
Male   3   3   6 
Region of Enrollment 
[Units: Participants]
     
United States   11   9   20 


  Outcome Measures
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1.  Primary:   Feasibility   [ Time Frame: One year ]

2.  Secondary:   Pre-Post Efficacy   [ Time Frame: Screen and 4 weeks (immediate treatment); Baseline and 4 weeks (waitlist treatment) ]


  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 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. Maurizio Fava
Organization: Massachusetts General Hospital
phone: 617-724-0838
e-mail: mfava@partners.org



Responsible Party: Maurizio Fava, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01103271     History of Changes
Other Study ID Numbers: 2009p002469
K24AT004095 ( U.S. NIH Grant/Contract )
First Submitted: April 9, 2010
First Posted: April 14, 2010
Results First Submitted: May 2, 2012
Results First Posted: January 14, 2013
Last Update Posted: January 14, 2013