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

Mass General Brigham

Status and phase: Completed; Phase 2

Conditions: Major Depressive Disorder

Treatments: Other: Open-label Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01103271

2009p002469

K24AT004095 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

---

20 participants in 2 patient groups, including a placebo group

Open-label Placebo Immediate Treatment

Experimental group

Description:

Participants will begin taking placebo pills for four weeks immediately after enrolling in the study.

Treatment:

Other: Open-label Placebo

Open-label Placebo Waitlist Treatment

Placebo Comparator group

Description:

Participants will wait two weeks after enrolling in the study to begin taking placebo pills for four weeks.

Treatment:

Other: Open-label Placebo