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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Major
Depressive Disorder
Depression
Disease
Mood Disorders
Mental Disorders
Behavioral Symptoms
Pathologic Processes

ClinicalTrials.gov processed this record on September 22, 2014