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

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ClinicalTrials.gov Identifier: NCT01103271
Recruitment Status : Completed
First Posted : April 14, 2010
Results First Posted : January 14, 2013
Last Update Posted : January 14, 2013
Sponsor:
Collaborators:
Harvard University
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Maurizio Fava, MD, Massachusetts General Hospital

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
Enrollment 20
Recruitment Details  
Pre-assignment Details A total of 33 participants were screened for this study.
Arm/Group Title Immediate Treatment Waitlist Treatment
Hide Arm/Group Description Participants will begin taking placebo pills for four weeks immediately after enrolling in the study. Participants will wait two weeks after enrolling in the study to begin taking placebo pills for four weeks.
Period Title: Overall Study
Started 11 9
Completed 10 5
Not Completed 1 4
Arm/Group Title Immediate Treatment Waitlist Treatment Total
Hide Arm/Group Description Participants will begin taking placebo pills for four weeks immediately after enrolling in the study. Participants will wait two weeks after enrolling in the study to begin taking placebo pills for four weeks. Total of all reporting groups
Overall Number of Baseline Participants 11 9 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 9 participants 20 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
11
 100.0%
9
 100.0%
20
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants 9 participants 20 participants
37.2  (12.0) 40.8  (13.7) 38.8  (12.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 9 participants 20 participants
Female
8
  72.7%
6
  66.7%
14
  70.0%
Male
3
  27.3%
3
  33.3%
6
  30.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants 9 participants 20 participants
11 9 20
1.Primary Outcome
Title Feasibility
Hide Description The primary outcome measure is feasibility, which was operationalized as the number of in-person screens for this study.
Time Frame One year
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed is the number of participants screened.
Arm/Group Title Placebo Effect Study
Hide Arm/Group Description:
These were all participants who were screened for the study but not yet enrolled.
Overall Number of Participants Analyzed 33
Measure Type: Number
Unit of Measure: screens
33
2.Secondary Outcome
Title Pre-Post Efficacy
Hide Description The magnitude of the pre-post effect across 4 weeks of treatment, as measured by the Hamilton Rating Scale for Depression-17 (HAMD-17). The HAMD-17 measures depression severity, and has a minimum value of 0 and a maximum value of 52 units on a scale, where higher scores indicate more severe depression.
Time Frame Screen and 4 weeks (immediate treatment); Baseline and 4 weeks (waitlist treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open Label-Placebo: Immediate Treatment Placebo Comparator: Waitlist Treatment
Hide Arm/Group Description:
Participants assigned to immediate treatment will begin taking placebo pills for four weeks immediately after enrolling in the study.
Participants will wait two weeks after enrolling in the study to begin taking placebo pills for four weeks.
Overall Number of Participants Analyzed 11 9
Mean (Standard Deviation)
Unit of Measure: units on a scale
14.75  (6.61) 3.25  (6.01)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Immediate Treatment Waitlist Treatment
Hide Arm/Group Description Participants will begin taking placebo pills for four weeks immediately after enrolling in the study. Participants will wait two weeks after enrolling in the study to begin taking placebo pills for four weeks.
All-Cause Mortality
Immediate Treatment Waitlist Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Immediate Treatment Waitlist Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)   0/9 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Immediate Treatment Waitlist Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)   0/9 (0.00%) 
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
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