Pilot Study of Open-label Placebo to Treat Major Depressive Disorder

NCT01103271 | Completed Phase 2 Results DMC

• 2 other identifiers: 2009p002469K24AT004095
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

depression; placebo effect; complementary therapies; alternative therapies

Outcome Measures

Primary Outcomes (1)

• Feasibility

  The primary outcome measure is feasibility, which was operationalized as the number of in-person screens for this study.

  One year

Secondary Outcomes (1)

• Pre-Post Efficacy

  Screen and 4 weeks (immediate treatment); Baseline and 4 weeks (waitlist treatment)

Study Arms (2)

Open-label Placebo Immediate Treatment

EXPERIMENTAL

Participants will begin taking placebo pills for four weeks immediately after enrolling in the study.

Other: Open-label Placebo

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.

Other: Open-label Placebo

Interventions

Open-label Placebo OTHER

Participants take open-label placebo pills - two twice daily for four weeks.

Open-label Placebo Immediate Treatment; Open-label Placebo Waitlist Treatment

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Men or women aged 18-60 years old.
• Current Major Depressive Disorder (MDD)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Harvard University: collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Dr. Maurizio Fava
• Organization: Massachusetts General Hospital

mfava@partners.org

617-724-0838

Study Officials

• Maurizio Fava, M.D.

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Depression Clinical and Research Program

Study Record Dates

• First Submitted: April 9, 2010
• First Posted: April 14, 2010
• Study Start: May 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: January 14, 2013
• Results First Posted: January 14, 2013

Record last verified: 2013-01

Locations

US (1)