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

Major Depressive Disorder Clinical Trial

Official title:

Harnessing the Placebo Effect in Major Depressive Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01103271
• Other study ID #: 2009p002469
• Secondary ID: K24AT004095
• Status: Completed
• Phase: Phase 2
• First received: April 9, 2010
• Last updated: January 8, 2013
• Start date: May 2010
• Est. completion date: May 2011

Study information

• Verified date: January 2013
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Other:
• Open-label Placebo
Participants take open-label placebo pills - two twice daily for four weeks.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Harvard University, National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility	The primary outcome measure is feasibility, which was operationalized as the number of in-person screens for this study.	One year	No
Secondary	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)	No