Harnessing the Placebo Effect in Major Depressive Disorder

Massachusetts General Hospital1 site in 1 country20 target enrollmentMay 2010

ConditionsMajor Depressive Disorder

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Major Depressive Disorder
Sponsor: Massachusetts General Hospital
Enrollment: 20
Locations: 1
Primary Endpoint: Feasibility
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 2010

End Date

May 2011

Last Updated

13 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Massachusetts General Hospital

Responsible Party

Principal Investigator

Maurizio Fava, MD

Director, Depression Clinical and Research Program

Massachusetts General Hospital

Eligibility 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.