Clinical trial NCT01103271: Pilot Study of Open-label Placebo to Treat Major Depressive Disorder
Official title: Harnessing the Placebo Effect in Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Major Depressive Disorder
Keywords: depression
placebo effect
complementary therapies
alternative therapies
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Harvard University
name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2010-04-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.
* Any concomitant form of psychotherapy (depression focused)

Primary outcomes:
measure: Feasibility
timeFrame: One year
Secondary outcomes:
measure: Pre-Post Efficacy
timeFrame: Screen and 4 weeks (immediate treatment); Baseline and 4 weeks (waitlist treatment)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Maurizio Fava, M.D.
role: PRINCIPAL_INVESTIGATOR
References: