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

This study has been completed.
Sponsor:
Collaborators:
Harvard University
Information provided by (Responsible Party):
Maurizio Fava, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01103271
First received: April 9, 2010
Last updated: January 8, 2013
Last verified: January 2013
  Purpose

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 Intervention Phase
Major Depressive Disorder
Other: Open-label Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Harnessing the Placebo Effect in Major Depressive Disorder

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Feasibility [ Time Frame: One year ] [ Designated as safety issue: No ]
    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 [ Time Frame: Screen and 4 weeks (immediate treatment); Baseline and 4 weeks (waitlist treatment) ] [ Designated as safety issue: No ]
    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.


Enrollment: 20
Study Start Date: May 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01103271

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Harvard University
Investigators
Principal Investigator: Maurizio Fava, M.D. Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Maurizio Fava, MD, Director, Depression Clinical and Research Program, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01103271     History of Changes
Other Study ID Numbers: 2009p002469, K24AT004095
Study First Received: April 9, 2010
Results First Received: May 2, 2012
Last Updated: January 8, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
depression
placebo effect
complementary therapies
alternative therapies

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

ClinicalTrials.gov processed this record on April 22, 2014