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

This study has been completed.
Sponsor:
Collaborators:
Harvard University
Information provided by (Responsible Party):
Maurizio Fava, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01103271
First received: April 9, 2010
Last updated: January 8, 2013
Last verified: January 2013
Results First Received: May 2, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Single Blind (Investigator);   Primary Purpose: Treatment
Condition: Major Depressive Disorder
Intervention: Other: Open-label Placebo

  Participant Flow
  Hide Participant Flow

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
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
  Hide Baseline Characteristics

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  
Number of Participants  
[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
  Show All Outcome Measures

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


  More Information
  Hide More Information

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.


Limitations and Caveats
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
No text entered.  


Results Point of Contact:  
Name/Title: Dr. Maurizio Fava
Organization: Massachusetts General Hospital
phone: 617-724-0838
e-mail: mfava@partners.org


No publications provided


Responsible Party: Maurizio Fava, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01103271     History of Changes
Other Study ID Numbers: 2009p002469, K24AT004095
Study First Received: April 9, 2010
Results First Received: May 2, 2012
Last Updated: January 8, 2013
Health Authority: United States: Institutional Review Board