Back to resultsPilot Study of Open-label Placebo to Treat Major Depressive Disorder
Primary Purpose
Major Depressive Disorder
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Open-label Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder focused on measuring depression, placebo effect, complementary therapies, alternative therapies
Eligibility Criteria
Inclusion Criteria:
- Men or women aged 18-60 years old.
- Current Major Depressive Disorder (MDD)
Exclusion Criteria:
- Pregnant women or women of child bearing potential not using a medically accepted means of contraception.
- Patients who are a serious suicide or homicide risk.
- Unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease.
- The following Diagnostic and Statistical Manual of Mental Disorders-IV diagnoses: 1) organic mental disorders; 2) substance use disorders, including alcohol, active within the last year; 3) schizophrenia; 4) delusional disorder; 5) psychotic disorders not elsewhere classified; 6) bipolar disorder; 7) acute bereavement; 9) severe borderline or antisocial personality disorder; 10) current primary diagnoses of panic disorder, social phobia, generalized anxiety disorder (GAD), or obsessive compulsive disorder (OCD) (disorders that present as chief complaint and/or have their onset preceding the onset of major depressive disorder).
- Uncontrolled seizure disorder.
- Patients with mood congruent or mood incongruent psychotic features.
- Current use of other psychotropic drugs. Exception: Patients who have been on a stable dose for 30 days of classes of medications such as non-benzodiazepine sedatives, anxiolytic benzodiazepines, non-narcotic analgesics may be included. Flexibility will be allowed based on physician discretion.
- Clinical or laboratory evidence of hypothyroidism.
- Patients who have taken an investigational psychotropic drug within the last year.
- Patients who have not responded to two or more antidepressant trials of adequate doses (e.g., fluoxetine 40 mg/day or higher) and duration (e.g.,for six weeks or more) over the past five years.
- Any concomitant form of psychotherapy (depression focused)
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Open-label Placebo Immediate Treatment
Open-label Placebo Waitlist Treatment
Arm 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.
Outcomes
Primary Outcome Measures
Feasibility
The primary outcome measure is feasibility, which was operationalized as the number of in-person screens for this study.
Secondary Outcome Measures
Pre-Post Efficacy
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.
Full Information
NCT ID
NCT01103271
First Posted
April 9, 2010
Last Updated
January 8, 2013
Sponsor
Massachusetts General Hospital
Collaborators
Harvard University, National Center for Complementary and Integrative Health (NCCIH)
1. Study Identification
Unique Protocol Identification Number
NCT01103271
Brief Title
Pilot Study of Open-label Placebo to Treat Major Depressive Disorder
Official Title
Harnessing the Placebo Effect in Major Depressive Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Harvard University, National Center for Complementary and Integrative Health (NCCIH)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Placebo pills (pills with no active ingredients) have been shown in research studies to somehow produce self-healing processes. The purpose of this study is to determine whether people will be willing to enter an open-label non-deceptive placebo treatment for Major Depressive Disorder (MDD) and whether open-label placebo can be effective for treating MDD in the context of a supportive physician-patient relationship.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
depression, placebo effect, complementary therapies, alternative therapies
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Open-label Placebo Immediate Treatment
Arm Type
Experimental
Arm Description
Participants will begin taking placebo pills for four weeks immediately after enrolling in the study.
Arm Title
Open-label Placebo Waitlist Treatment
Arm Type
Placebo Comparator
Arm Description
Participants will wait two weeks after enrolling in the study to begin taking placebo pills for four weeks.
Intervention Type
Other
Intervention Name(s)
Open-label Placebo
Intervention Description
Participants take open-label placebo pills - two twice daily for four weeks.
Primary Outcome Measure Information:
Title
Feasibility
Description
The primary outcome measure is feasibility, which was operationalized as the number of in-person screens for this study.
Time Frame
One year
Secondary Outcome Measure Information:
Title
Pre-Post Efficacy
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men or women aged 18-60 years old.
Current Major Depressive Disorder (MDD)
Exclusion Criteria:
Pregnant women or women of child bearing potential not using a medically accepted means of contraception.
Patients who are a serious suicide or homicide risk.
Unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease.
The following Diagnostic and Statistical Manual of Mental Disorders-IV diagnoses: 1) organic mental disorders; 2) substance use disorders, including alcohol, active within the last year; 3) schizophrenia; 4) delusional disorder; 5) psychotic disorders not elsewhere classified; 6) bipolar disorder; 7) acute bereavement; 9) severe borderline or antisocial personality disorder; 10) current primary diagnoses of panic disorder, social phobia, generalized anxiety disorder (GAD), or obsessive compulsive disorder (OCD) (disorders that present as chief complaint and/or have their onset preceding the onset of major depressive disorder).
Uncontrolled seizure disorder.
Patients with mood congruent or mood incongruent psychotic features.
Current use of other psychotropic drugs. Exception: Patients who have been on a stable dose for 30 days of classes of medications such as non-benzodiazepine sedatives, anxiolytic benzodiazepines, non-narcotic analgesics may be included. Flexibility will be allowed based on physician discretion.
Clinical or laboratory evidence of hypothyroidism.
Patients who have taken an investigational psychotropic drug within the last year.
Patients who have not responded to two or more antidepressant trials of adequate doses (e.g., fluoxetine 40 mg/day or higher) and duration (e.g.,for six weeks or more) over the past five years.
Any concomitant form of psychotherapy (depression focused)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maurizio Fava, M.D.
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Pilot Study of Open-label Placebo to Treat Major Depressive Disorder
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