Major Depressive Disorder
Conditions
Keywords
depression, placebo effect, complementary therapies, alternative therapies
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.
Interventions
OTHEROpen-label Placebo
Participants take open-label placebo pills - two twice daily for four weeks.
Sponsors
Harvard University
National Center for Complementary and Integrative Health (NCCIH)
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility | One year | The primary outcome measure is feasibility, which was operationalized as the number of in-person screens for this study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Pre-assignment details
A total of 33 participants were screened for this study.
Participants by arm
| Arm | Count |
|---|---|
| Immediate Treatment Participants will begin taking placebo pills for four weeks immediately after enrolling in the study. | 11 |
| Waitlist Treatment Participants will wait two weeks after enrolling in the study to begin taking placebo pills for four weeks. | 9 |
| Total | 20 |
Baseline characteristics
| Characteristic | Waitlist Treatment | Immediate Treatment | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 11 Participants | 20 Participants |
| Age Continuous | 40.8 years STANDARD_DEVIATION 13.7 | 37.2 years STANDARD_DEVIATION 12 | 38.8 years STANDARD_DEVIATION 12.6 |
| Region of Enrollment United States | 9 participants | 11 participants | 20 participants |
| Sex: Female, Male Female | 6 Participants | 8 Participants | 14 Participants |
| Sex: Female, Male Male | 3 Participants | 3 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 11 | 0 / 9 |
| serious Total, serious adverse events | 0 / 11 | 0 / 9 |
Outcome results
Primary
Feasibility
The primary outcome measure is feasibility, which was operationalized as the number of in-person screens for this study.
Time frame: One year
Population: The number of participants analyzed is the number of participants screened.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Placebo Effect Study | Feasibility | 33 screens | 0 |
Secondary
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.
Time frame: Screen and 4 weeks (immediate treatment); Baseline and 4 weeks (waitlist treatment)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Effect Study | Pre-Post Efficacy | 14.75 units on a scale | Standard Deviation 6.61 |
| Placebo Comparator: Waitlist Treatment | Pre-Post Efficacy | 3.25 units on a scale | Standard Deviation 6.01 |