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.

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Other: Open-label Placebo

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility	The primary outcome measure is feasibility, which was operationalized as the number of in-person screens for this study.	One year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Screen and 4 weeks (immediate treatment); Baseline and 4 weeks (waitlist treatment)

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: National Center for Complementary and Integrative Health (NCCIH); Harvard University

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: April 9, 2010
• First Submitted That Met QC Criteria: April 12, 2010
• First Posted (Estimate): April 14, 2010

Study Record Updates

• Last Update Posted (Estimate): January 14, 2013
• Last Update Submitted That Met QC Criteria: January 8, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: depression; placebo effect; complementary therapies; alternative therapies
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: 2009p002469; K24AT004095 (NIH)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No