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

Study Overview
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Brief Summary
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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.

Official Title
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Harnessing the Placebo Effect in Major Depressive Disorder

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Other: Open-label Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open-label Placebo Immediate Treatment<br>Participants will begin taking placebo pills for four weeks immediately after enrolling in the study. | Other: Open-label Placebo<br>* Participants take open-label placebo pills - two twice daily for four weeks.<br>|
| Placebo Comparator: Open-label Placebo Waitlist Treatment<br>Participants will wait two weeks after enrolling in the study to begin taking placebo pills for four weeks. | Other: Open-label Placebo<br>* Participants take open-label placebo pills - two twice daily for four weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility | The primary outcome measure is feasibility, which was operationalized as the number of in-person screens for this study. | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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depression, placebo effect, complementary therapies, alternative therapies