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

Phase 2

Completed

• Conditions: Major Depressive Disorder
• Interventions: Other: Open-label Placebo

• Registration Number: NCT01103271
• Lead Sponsor: Massachusetts General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-04-09
• Study First Submitted QC: 2010-04-12
• Study First Posted: 2010-04-14
• Study Start: 2010-05
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Results First Submitted: 2012-05-02
• Status Verified: 2013-01
• Results First Submitted QC: 2013-01-08
• Last Update Submitted: 2013-01-08
• Results First Posted: 2013-01-14
• Last Update Posted: 2013-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Open-label Placebo Immediate Treatment	Open-label Placebo	Participants will begin taking placebo pills for four weeks immediately after enrolling in the study.
Open-label Placebo Waitlist Treatment	Open-label Placebo	Participants will wait two weeks after enrolling in the study to begin taking placebo pills for four weeks.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Pre-Post Efficacy	Screen and 4 weeks (immediate treatment); Baseline and 4 weeks (waitlist treatment)	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.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States