Pilot Study of Open-label Placebo to Treat Major Depressive Disorder
This study has been completed.
Sponsor:
Massachusetts General Hospital
Collaborators:
Harvard University
Information provided by (Responsible Party):
Maurizio Fava, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01103271
First received: April 9, 2010
Last updated: January 8, 2013
Last verified: January 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Major Depressive Disorder |
Other: Open-label Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
| Official Title: | Harnessing the Placebo Effect in Major Depressive Disorder |
Resource links provided by NLM:
Further study details as provided by Massachusetts General Hospital:
Primary Outcome Measures:
- Feasibility [ Time Frame: One year ] [ Designated as safety issue: No ]The primary outcome measure is feasibility, which was operationalized as the number of in-person screens for this study.
Secondary Outcome Measures:
- Pre-Post Efficacy [ Time Frame: Screen and 4 weeks (immediate treatment); Baseline and 4 weeks (waitlist treatment) ] [ Designated as safety issue: No ]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.
| Enrollment: | 20 |
| Study Start Date: | May 2010 |
| Study Completion Date: | May 2011 |
| Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Open-label Placebo Immediate Treatment
Participants will begin taking placebo pills for four weeks immediately after enrolling in the study.
|
Other: Open-label Placebo
Participants take open-label placebo pills - two twice daily for four weeks.
|
|
Placebo Comparator: Open-label Placebo Waitlist Treatment
Participants will wait two weeks after enrolling in the study to begin taking placebo pills for four weeks.
|
Other: Open-label Placebo
Participants take open-label placebo pills - two twice daily for four weeks.
|
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01103271
Locations
| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
Sponsors and Collaborators
Massachusetts General Hospital
Harvard University
Investigators
| Principal Investigator: | Maurizio Fava, M.D. | Massachusetts General Hospital |
More Information
No publications provided
| Responsible Party: | Maurizio Fava, MD, Director, Depression Clinical and Research Program, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT01103271 History of Changes |
| Other Study ID Numbers: | 2009p002469, K24AT004095 |
| Study First Received: | April 9, 2010 |
| Results First Received: | May 2, 2012 |
| Last Updated: | January 8, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Massachusetts General Hospital:
|
depression placebo effect complementary therapies alternative therapies |
Additional relevant MeSH terms:
|
Depressive Disorder Depression Depressive Disorder, Major |
Mood Disorders Mental Disorders Behavioral Symptoms |
ClinicalTrials.gov processed this record on June 17, 2013