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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
Harvard University
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Maurizio Fava, MD, Massachusetts General Hospital

April 9, 2010
April 14, 2010
May 2, 2012
January 14, 2013
January 14, 2013
May 2010
May 2011   (Final data collection date for primary outcome measure)
Feasibility [ Time Frame: One year ]
The primary outcome measure is feasibility, which was operationalized as the number of in-person screens for this study.
Feasibility [ Time Frame: One year ]
Percentage of eligible patients with Major Depressive Disorder who consent to participate in the study.
Complete list of historical versions of study NCT01103271 on ClinicalTrials.gov Archive Site
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.
Efficacy [ Time Frame: One year ]
The magnitude of the pre-post effect across 4 weeks of treatment. The magnitude of the difference between non-deceptive antidepressant placebo and waitlist
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Pilot Study of Open-label Placebo to Treat Major Depressive Disorder
Harnessing the Placebo Effect in Major Depressive Disorder
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.
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Phase 2
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Major Depressive Disorder
Other: Open-label Placebo
Participants take open-label placebo pills - two twice daily for four weeks.
  • Experimental: Open-label Placebo Immediate Treatment
    Participants will begin taking placebo pills for four weeks immediately after enrolling in the study.
    Intervention: Other: Open-label Placebo
  • 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.
    Intervention: Other: Open-label Placebo
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
May 2011
May 2011   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
K24AT004095 ( U.S. NIH Grant/Contract )
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Not Provided
Maurizio Fava, MD, Massachusetts General Hospital
Massachusetts General Hospital
  • Harvard University
  • National Center for Complementary and Integrative Health (NCCIH)
Principal Investigator: Maurizio Fava, M.D. Massachusetts General Hospital
Massachusetts General Hospital
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP