Pilot Study of Open-label Placebo to Treat Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Open-label Placebo
Intervention description: Participants take open-label placebo pills - two twice daily for four weeks.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: depression; placebo effect; complementary therapies; alternative therapies

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)