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

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

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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Other: Open-label Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Harnessing the Placebo Effect in Major Depressive Disorder
Study Start Date : May 2010
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Open-label Placebo Immediate Treatment
Participants will begin taking placebo pills for four weeks immediately after enrolling in the study.
Other: Open-label Placebo
Participants take open-label placebo pills - two twice daily for four weeks.

Placebo Comparator: Open-label Placebo Waitlist Treatment
Participants will wait two weeks after enrolling in the study to begin taking placebo pills for four weeks.
Other: Open-label Placebo
Participants take open-label placebo pills - two twice daily for four weeks.

Primary Outcome Measures :
  1. Feasibility [ Time Frame: One year ]
    The primary outcome measure is feasibility, which was operationalized as the number of in-person screens for this study.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01103271

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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Harvard University
National Center for Complementary and Integrative Health (NCCIH)
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Principal Investigator: Maurizio Fava, M.D. Massachusetts General Hospital

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Responsible Party: Maurizio Fava, MD, Director, Depression Clinical and Research Program, Massachusetts General Hospital Identifier: NCT01103271     History of Changes
Other Study ID Numbers: 2009p002469
K24AT004095 ( U.S. NIH Grant/Contract )
First Posted: April 14, 2010    Key Record Dates
Results First Posted: January 14, 2013
Last Update Posted: January 14, 2013
Last Verified: January 2013

Keywords provided by Maurizio Fava, MD, Massachusetts General Hospital:
placebo effect
complementary therapies
alternative therapies

Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms