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| ID | Type | Description | Link |
|---|---|---|---|
| K24AT004095 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Harvard University | OTHER |
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open-label Placebo Immediate Treatment | Experimental | Participants will begin taking placebo pills for four weeks immediately after enrolling in the study. |
|
| Open-label Placebo Waitlist Treatment | Placebo Comparator | Participants will wait two weeks after enrolling in the study to begin taking placebo pills for four weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Open-label Placebo | Other | Participants take open-label placebo pills - two twice daily for four weeks. |
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| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maurizio Fava, M.D. | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
A total of 33 participants were screened for this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Immediate Treatment | Participants will begin taking placebo pills for four weeks immediately after enrolling in the study. |
| FG001 | Waitlist Treatment | Participants will wait two weeks after enrolling in the study to begin taking placebo pills for four weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Immediate Treatment | Participants will begin taking placebo pills for four weeks immediately after enrolling in the study. |
| BG001 | Waitlist Treatment | Participants will wait two weeks after enrolling in the study to begin taking placebo pills for four weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility | The primary outcome measure is feasibility, which was operationalized as the number of in-person screens for this study. | The number of participants analyzed is the number of participants screened. | Posted | Number | screens | One year |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Immediate Treatment | Participants will begin taking placebo pills for four weeks immediately after enrolling in the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Maurizio Fava | Massachusetts General Hospital | 617-724-0838 | mfava@partners.org |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
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| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
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| 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. | Posted | Mean | Standard Deviation | units on a scale | Screen and 4 weeks (immediate treatment); Baseline and 4 weeks (waitlist treatment) |
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | Waitlist Treatment | Participants will wait two weeks after enrolling in the study to begin taking placebo pills for four weeks. | 0 | 9 | 0 | 9 |
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| D001519 |
| Behavior |